Degenerative Disc Disease, Grade 1 Spondylolisthesis
Conditions
Keywords
degenerative disc disease, DDD, Grade 1 spondylolisthesis, spondylolisthesis, L2-S1
Brief summary
An evaluation of the incidence of complications resulting from far lateral spine surgery utilizing the K2M RAVINE® Lateral Access System (RAVINE) with ALEUTIAN® Lateral Interbody Spacer System versus literature reported results for the NuVasive XLIF® system (XLIF) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis.
Detailed description
An evaluation of the incidence of complications resulting from far lateral spine surgery utilizing the K2M RAVINE® Lateral Access System (RAVINE) with ALEUTIAN® Lateral Interbody Spacer System versus literature reported results for the NuVasive XLIF® system (XLIF) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at L2-S1 requiring surgical intervention at one or two contiguous levels. Safety will be assessed by the following: 1.) Evaluation of all adverse events including device related, procedure related and additional serious adverse events; 2.) Additional surgical intervention at the operative site including the need for removals, revisions, re-operations or supplemental fixation required to modify the device; and 3.) The incidence and severity of any psoas muscle injury, genital femoral nerve injury and lumbar plexus injury will be determined for all patients. Supplemental fixation of any kind may be included as long as the procedure is completed via a minimally invasive approach.
Interventions
None listed
Sponsors
K2M, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of DDD with up to Grade 1 spondylolisthesis, confirmed clinically and radiographically, requiring surgical intervention at one or two contiguous levels between L2-S1 * Inadequate response to conservative medical care over a period of at least 6 months * Willing and able to comply with the requirements of the protocol including follow-up requirements * Willing and able to sign a study specific informed consent * Skeletally mature and ≥ 18 years of age at the time of enrollment
Exclusion criteria
* Previous anterior/posterior/lateral spine surgery at the index level * Previous posterior/lateral spine surgery (e.g., posterior element decompression) that destabilizes the lumbar spine * Active systemic infection or infection at the operative site * Co-morbid medical conditions of the spine or upper/lower extremities that may affect the lumbar spine neurological and/or pain assessment * Metabolic bone disease such as osteoporosis that contradicts spinal surgery * History of an osteoporotic fracture * History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism * Taking medications that may interfere with bony/soft tissue healing including chronic steroid use * Known allergy to titanium, cobalt chrome or PEEK * Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia * Current medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion * Pregnant, or intend to become pregnant, during the course of the study * Severe obesity (Body Mass Index \> 40) * Physical or mental condition (e.g., psychiatric disorder, senile dementia, Alzheimer's disease, alcohol or drug addiction) that would interfere with patient self-assessment of function, pain or quality of life * Involved in current or pending spinal litigation where permanent disability benefits are being sought * Incarcerated at the time of study enrollment * Current participation in an investigational study that may impact study outcomes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) Change From Baseline | 24 months | Evaluation of the change of the Back VAS, Hip VAS and the Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms were captured and evaluated. VAS scale ranged from 0 - 10cm with the 10cm accounting for the highest level of pain. |
| Number of Patients With Adverse Events AEs) | Operative to 24 month | The evaluation of all adverse events including device related, procedure related and additional serious adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Health-Related Quality of Life From Baseline (Pre-op) | time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months | Health-related quality of life was evaluated in all study subjects using the SF-12v2 Health Survey. This shortened and simplified version of the SF-36 makes the questionnaire less ambiguous for patients. It has a self-administered form that makes it easy to read and complete, and that reduces missing responses. The physical and mental component summary scales, referred to as PCS-12 and MCS-12 were evaluated against published normative values and a 15% improvement in these scores was used as an assessment of success. In calculating the true value of a treatment, the scores from the SF-12v2 were converted into a utility index (SF-6D), which considered not only how many years a medical intervention could have added to a patient's life, but also the quality of that life. Use of the SF-6D did not expand the questions administered to the patients. The scale ranged from 0-100% with 100% being the best quality of life. |
| Radiographic Assessments | 12 mo to 24 mo | Quantitative and qualitative radiographic assessment of the pre and post-operative AP, and Lateral, Flexion/Extension images were performed. Radiographic and qualitative assessments performed include: * Device Condition: looks at both the cage inside the vertebrae and the hardware outside the vertebrae. It looks at whether or not the device is intact or not (subsidence or migration) * Fusion/Non-fusion: whether bone has grown within the space between the spinal vertebrae. If fusion occurs, it results in Bony Bridging |
| Patient Satisfaction | 12 month and 24 month | At the 12 month and 24 month follow-up visits, subjects were asked whether they were satisfied with the outcome of their surgery (Yes/No) and whether they would repeat the operation (Yes/No). |
| Odom's Criteria | 24 months | At the 24 month follow-up visit, the Investigator rated the clinical disposition of each study subject according to Odom's Criteria as follows: Excellent: all pre-operative symptoms relieved, able to carry out daily occupations without impairment. Good: minimum persistence of pre-operative symptoms, able to carry out daily occupations without significant interference. Fair/Satisfactory: relief of some pre-operative symptoms but physical activity is significantly limited. Poor: symptoms or signs unchanged or worse. |
| Surgery Time | During operation. | The length of the surgical procedure from the initial incision to final closure were captured from the Anesthesia Record. |
| Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months | Neurological evaluation of the patient, with specific evaluation of psoas muscle weakness, radiating radicular pain, knee extension weakness, dorsiflexion weakness, plantarflexion weakness and anterior thigh numbness was performed using Patient symptom Questionnaire (0-100mm analog scale with 100mm being the highest pain/weakness/numbness) |
| Estimated Blood Loss | During Operation | The amount of blood loss over the entire length of the surgery, documented on the Anesthesia Record, was captured. |
| Number of Participants With Abnormal Neuromonitoring System Results | During operation | Abnormal result(s) of neuromonitoring systems (Train of Four, Electromyography (EMG), Triggered EMG, Somato Sensory Evoked Potential (SSEP) and Motor Evoked Potential (MEP)) utilized during the surgery were captured. |
| Length of Hospital Stay | From admission to discharge | The length of hospital stay from the date of hospital admission to the date of discharge was calculated. |
| Change in Work/School Status Compared to Baseline | Pre-operative to 24 months | The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery was documented. |
| Change in Use of Narcotics Post-Surgery Compared to Baseline | Pre-operative to 24 months | The types and dosages of any narcotics taken by the patient post-surgery were documented. |
| Anesthesia Time | During operation. | The length of time the patient is under anesthesia were captured from the Anesthesia Record. |
| Change in Oswestry Disability Index From Baseline (Pre-Operative) | time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months | The Oswestry Disability Index (ODI) is a validated instrument including items that relate to subjective symptomatology and activities of daily living (pain intensity, personal care, lifting, walking, sitting, standing, sex life, traveling). This patient-reported outcome measure is a 10 item questionnaire that evaluates disability and functional impairment associated with back problems. Each item is scored from O up to 5, with higher scores corresponding to greater disability. A total ODI score is determined by adding the scores of the individual questions and dividing that total by the maximum possible score (i.e., 50 if all questions are answered) to yield a percentage. Therefore, the ODI score ranges from 0% to 100%. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Demographics and Baseline Characteristics This is a demographic and baseline characteristics of the patient population. This includes parameters such as Age, Gender, Height, Weight Body Mass Index (BMI) and Tobacco Usage. | 125 |
| Total | 125 |
Baseline characteristics
| Characteristic | Demographics and Baseline Characteristics |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 48 Participants |
| Age, Categorical Between 18 and 65 years | 77 Participants |
| Age, Continuous | 61.8 years STANDARD_DEVIATION 9.7 |
| Body Mass Index (BMI) | 28.48 lbs/(in^2)*703 STANDARD_DEVIATION 4.4 |
| Height | 65.96 inches STANDARD_DEVIATION 3.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 125 Participants |
| Sex: Female, Male Female | 78 Participants |
| Sex: Female, Male Male | 47 Participants |
| Tobacco Use Currently Use | 19 Participants |
| Tobacco Use Missing | 0 Participants |
| Tobacco Use Never | 63 Participants |
| Tobacco Use Quit | 43 Participants |
| Weight | 177.2 pounds STANDARD_DEVIATION 36.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 125 |
| other Total, other adverse events | 73 / 125 |
| serious Total, serious adverse events | 30 / 125 |
Outcome results
Primary
Number of Patients With Adverse Events AEs)
The evaluation of all adverse events including device related, procedure related and additional serious adverse events.
Time frame: Operative to 24 month
Population: This is an analysis of the number of participants that reported any form of adverse event. Participants were evaluated for all adverse events including device related, procedure related, and additional serious adverse events.~9 of the 30 SAE participants did not experience a non-SAE events. The other 21 participants had events in both categories
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Back | Number of Patients With Adverse Events AEs) | Any AE : Procedure Related | 23 participants |
| Back | Number of Patients With Adverse Events AEs) | Any SAE : Severe | 5 participants |
| Back | Number of Patients With Adverse Events AEs) | Any SAE : Moderate | 4 participants |
| Back | Number of Patients With Adverse Events AEs) | Any SAE : Mild | 3 participants |
| Back | Number of Patients With Adverse Events AEs) | Any SAE : Device Related | 1 participants |
| Back | Number of Patients With Adverse Events AEs) | Any SAE : Procedure Related | 4 participants |
| Back | Number of Patients With Adverse Events AEs) | Any Serious Adverse Event (SAE) | 10 participants |
| Back | Number of Patients With Adverse Events AEs) | Any AE : Severe | 5 participants |
| Back | Number of Patients With Adverse Events AEs) | Any AE | 45 participants |
| Back | Number of Patients With Adverse Events AEs) | Any AE : Moderate | 21 participants |
| Back | Number of Patients With Adverse Events AEs) | Any AE : Mild | 28 participants |
| Back | Number of Patients With Adverse Events AEs) | Any AE : Device Related | 4 participants |
| Left Hip | Number of Patients With Adverse Events AEs) | Any AE | 16 participants |
| Left Hip | Number of Patients With Adverse Events AEs) | Any AE : Procedure Related | 3 participants |
| Left Hip | Number of Patients With Adverse Events AEs) | Any AE : Device Related | 2 participants |
| Left Hip | Number of Patients With Adverse Events AEs) | Any AE : Mild | 7 participants |
| Left Hip | Number of Patients With Adverse Events AEs) | Any AE : Moderate | 7 participants |
| Left Hip | Number of Patients With Adverse Events AEs) | Any AE : Severe | 4 participants |
| Left Hip | Number of Patients With Adverse Events AEs) | Any Serious Adverse Event (SAE) | 4 participants |
| Left Hip | Number of Patients With Adverse Events AEs) | Any SAE : Procedure Related | 0 participants |
| Left Hip | Number of Patients With Adverse Events AEs) | Any SAE : Device Related | 1 participants |
| Left Hip | Number of Patients With Adverse Events AEs) | Any SAE : Mild | 0 participants |
| Left Hip | Number of Patients With Adverse Events AEs) | Any SAE : Moderate | 1 participants |
| Left Hip | Number of Patients With Adverse Events AEs) | Any SAE : Severe | 3 participants |
| Right Hip | Number of Patients With Adverse Events AEs) | Any AE : Severe | 3 participants |
| Right Hip | Number of Patients With Adverse Events AEs) | Any AE : Device Related | 3 participants |
| Right Hip | Number of Patients With Adverse Events AEs) | Any SAE : Device Related | 0 participants |
| Right Hip | Number of Patients With Adverse Events AEs) | Any SAE : Procedure Related | 0 participants |
| Right Hip | Number of Patients With Adverse Events AEs) | Any Serious Adverse Event (SAE) | 3 participants |
| Right Hip | Number of Patients With Adverse Events AEs) | Any AE : Procedure Related | 4 participants |
| Right Hip | Number of Patients With Adverse Events AEs) | Any AE : Mild | 7 participants |
| Right Hip | Number of Patients With Adverse Events AEs) | Any SAE : Moderate | 1 participants |
| Right Hip | Number of Patients With Adverse Events AEs) | Any AE : Moderate | 15 participants |
| Right Hip | Number of Patients With Adverse Events AEs) | Any SAE : Severe | 2 participants |
| Right Hip | Number of Patients With Adverse Events AEs) | Any AE | 22 participants |
| Right Hip | Number of Patients With Adverse Events AEs) | Any SAE : Mild | 0 participants |
| Left Leg | Number of Patients With Adverse Events AEs) | Any SAE : Mild | 1 participants |
| Left Leg | Number of Patients With Adverse Events AEs) | Any AE : Mild | 19 participants |
| Left Leg | Number of Patients With Adverse Events AEs) | Any AE : Severe | 5 participants |
| Left Leg | Number of Patients With Adverse Events AEs) | Any AE : Moderate | 12 participants |
| Left Leg | Number of Patients With Adverse Events AEs) | Any SAE : Moderate | 1 participants |
| Left Leg | Number of Patients With Adverse Events AEs) | Any Serious Adverse Event (SAE) | 7 participants |
| Left Leg | Number of Patients With Adverse Events AEs) | Any SAE : Procedure Related | 1 participants |
| Left Leg | Number of Patients With Adverse Events AEs) | Any SAE : Device Related | 0 participants |
| Left Leg | Number of Patients With Adverse Events AEs) | Any SAE : Severe | 5 participants |
| Left Leg | Number of Patients With Adverse Events AEs) | Any AE : Procedure Related | 6 participants |
| Left Leg | Number of Patients With Adverse Events AEs) | Any AE | 33 participants |
| Left Leg | Number of Patients With Adverse Events AEs) | Any AE : Device Related | 2 participants |
| Right Leg | Number of Patients With Adverse Events AEs) | Any AE : Device Related | 2 participants |
| Right Leg | Number of Patients With Adverse Events AEs) | Any SAE : Severe | 6 participants |
| Right Leg | Number of Patients With Adverse Events AEs) | Any AE : Severe | 6 participants |
| Right Leg | Number of Patients With Adverse Events AEs) | Any SAE : Device Related | 1 participants |
| Right Leg | Number of Patients With Adverse Events AEs) | Any AE : Mild | 9 participants |
| Right Leg | Number of Patients With Adverse Events AEs) | Any AE : Moderate | 14 participants |
| Right Leg | Number of Patients With Adverse Events AEs) | Any SAE : Mild | 2 participants |
| Right Leg | Number of Patients With Adverse Events AEs) | Any AE | 23 participants |
| Right Leg | Number of Patients With Adverse Events AEs) | Any Serious Adverse Event (SAE) | 10 participants |
| Right Leg | Number of Patients With Adverse Events AEs) | Any AE : Procedure Related | 4 participants |
| Right Leg | Number of Patients With Adverse Events AEs) | Any SAE : Moderate | 3 participants |
| Right Leg | Number of Patients With Adverse Events AEs) | Any SAE : Procedure Related | 1 participants |
| Overall | Number of Patients With Adverse Events AEs) | Any SAE : Moderate | 10 participants |
| Overall | Number of Patients With Adverse Events AEs) | Any SAE : Procedure Related | 6 participants |
| Overall | Number of Patients With Adverse Events AEs) | Any AE | 82 participants |
| Overall | Number of Patients With Adverse Events AEs) | Any Serious Adverse Event (SAE) | 30 participants |
| Overall | Number of Patients With Adverse Events AEs) | Any AE : Procedure Related | 34 participants |
| Overall | Number of Patients With Adverse Events AEs) | Any AE : Severe | 20 participants |
| Overall | Number of Patients With Adverse Events AEs) | Any SAE : Mild | 6 participants |
| Overall | Number of Patients With Adverse Events AEs) | Any SAE : Device Related | 2 participants |
| Overall | Number of Patients With Adverse Events AEs) | Any SAE : Severe | 18 participants |
| Overall | Number of Patients With Adverse Events AEs) | Any AE : Mild | 51 participants |
| Overall | Number of Patients With Adverse Events AEs) | Any AE : Moderate | 52 participants |
| Overall | Number of Patients With Adverse Events AEs) | Any AE : Device Related | 10 participants |
Primary
Visual Analog Scale (VAS) Change From Baseline
Evaluation of the change of the Back VAS, Hip VAS and the Leg VAS at the 24 month post-operative visit as compared to pre-op time periods. Information on all reports of pain/numbness/tingling and the location of symptoms were captured and evaluated. VAS scale ranged from 0 - 10cm with the 10cm accounting for the highest level of pain.
Time frame: 24 months
Population: All patients were accounted for
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Back | Visual Analog Scale (VAS) Change From Baseline | -4.3 score on a scale | Standard Deviation 3.7 |
| Left Hip | Visual Analog Scale (VAS) Change From Baseline | -2.3 score on a scale | Standard Deviation 3.8 |
| Right Hip | Visual Analog Scale (VAS) Change From Baseline | -4.0 score on a scale | Standard Deviation 3.7 |
| Left Leg | Visual Analog Scale (VAS) Change From Baseline | -2.1 score on a scale | Standard Deviation 3.4 |
| Right Leg | Visual Analog Scale (VAS) Change From Baseline | -3.5 score on a scale | Standard Deviation 4 |
Secondary
Anesthesia Time
The length of time the patient is under anesthesia were captured from the Anesthesia Record.
Time frame: During operation.
Population: 3 of 125 subjects did not have surgery time included. There were 12 staged procedures increasing the overall number of procedures to 134
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Back | Anesthesia Time | 219.8 Minutes | Standard Deviation 84.9 |
Secondary
Change in Health-Related Quality of Life From Baseline (Pre-op)
Health-related quality of life was evaluated in all study subjects using the SF-12v2 Health Survey. This shortened and simplified version of the SF-36 makes the questionnaire less ambiguous for patients. It has a self-administered form that makes it easy to read and complete, and that reduces missing responses. The physical and mental component summary scales, referred to as PCS-12 and MCS-12 were evaluated against published normative values and a 15% improvement in these scores was used as an assessment of success. In calculating the true value of a treatment, the scores from the SF-12v2 were converted into a utility index (SF-6D), which considered not only how many years a medical intervention could have added to a patient's life, but also the quality of that life. Use of the SF-6D did not expand the questions administered to the patients. The scale ranged from 0-100% with 100% being the best quality of life.
Time frame: time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months
Population: The number analyzed in Mental Health and Physical Health rows for 6 Months and 12 Months differ due to the inability for a participant to complete the required forms for those two intervals.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Back | Change in Health-Related Quality of Life From Baseline (Pre-op) | Mental Health | 0.01 score on a scale | Standard Deviation 10 |
| Back | Change in Health-Related Quality of Life From Baseline (Pre-op) | Physical Health | 0.6 score on a scale | Standard Deviation 6.8 |
| Left Hip | Change in Health-Related Quality of Life From Baseline (Pre-op) | Mental Health | 4.0 score on a scale | Standard Deviation 12.4 |
| Left Hip | Change in Health-Related Quality of Life From Baseline (Pre-op) | Physical Health | 4.6 score on a scale | Standard Deviation 9.3 |
| Right Hip | Change in Health-Related Quality of Life From Baseline (Pre-op) | Mental Health | 4.8 score on a scale | Standard Deviation 11.6 |
| Right Hip | Change in Health-Related Quality of Life From Baseline (Pre-op) | Physical Health | 8.2 score on a scale | Standard Deviation 9.2 |
| Left Leg | Change in Health-Related Quality of Life From Baseline (Pre-op) | Mental Health | 7.6 score on a scale | Standard Deviation 12.7 |
| Left Leg | Change in Health-Related Quality of Life From Baseline (Pre-op) | Physical Health | 9.7 score on a scale | Standard Deviation 11.5 |
| Right Leg | Change in Health-Related Quality of Life From Baseline (Pre-op) | Mental Health | 7.6 score on a scale | Standard Deviation 10.7 |
| Right Leg | Change in Health-Related Quality of Life From Baseline (Pre-op) | Physical Health | 12.9 score on a scale | Standard Deviation 9 |
| Overall | Change in Health-Related Quality of Life From Baseline (Pre-op) | Mental Health | 7.1 score on a scale | Standard Deviation 11.9 |
| Overall | Change in Health-Related Quality of Life From Baseline (Pre-op) | Physical Health | 11.5 score on a scale | Standard Deviation 10.1 |
Secondary
Change in Oswestry Disability Index From Baseline (Pre-Operative)
The Oswestry Disability Index (ODI) is a validated instrument including items that relate to subjective symptomatology and activities of daily living (pain intensity, personal care, lifting, walking, sitting, standing, sex life, traveling). This patient-reported outcome measure is a 10 item questionnaire that evaluates disability and functional impairment associated with back problems. Each item is scored from O up to 5, with higher scores corresponding to greater disability. A total ODI score is determined by adding the scores of the individual questions and dividing that total by the maximum possible score (i.e., 50 if all questions are answered) to yield a percentage. Therefore, the ODI score ranges from 0% to 100%.
Time frame: time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months
Population: 131 patients started the study at Pre-op, 6 patients did not complete the survey; 125 started operative, 34 patients did not complete the survey at Discharge; 121 started the Post-operative interval, 4 patients did not complete the survey; 111 patients started at 3 Month interval, 4 patients did not complete the survey; All patients who started at 6 months and 24 months completed their surveys at their respective intervals.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Back | Change in Oswestry Disability Index From Baseline (Pre-Operative) | 7.7 score on a scale | Standard Deviation 19.5 |
| Left Hip | Change in Oswestry Disability Index From Baseline (Pre-Operative) | -10.1 score on a scale | Standard Deviation 21.1 |
| Right Hip | Change in Oswestry Disability Index From Baseline (Pre-Operative) | -17.3 score on a scale | Standard Deviation 18.5 |
| Left Leg | Change in Oswestry Disability Index From Baseline (Pre-Operative) | -22.7 score on a scale | Standard Deviation 19 |
| Right Leg | Change in Oswestry Disability Index From Baseline (Pre-Operative) | -26.9 score on a scale | Standard Deviation 17.5 |
| Overall | Change in Oswestry Disability Index From Baseline (Pre-Operative) | -24.3 score on a scale | Standard Deviation 17.6 |
Secondary
Change in Pain/Dysesthesia Score From Baseline (Pre-Operative)
Neurological evaluation of the patient, with specific evaluation of psoas muscle weakness, radiating radicular pain, knee extension weakness, dorsiflexion weakness, plantarflexion weakness and anterior thigh numbness was performed using Patient symptom Questionnaire (0-100mm analog scale with 100mm being the highest pain/weakness/numbness)
Time frame: time of discharge, an average of 4.5 days, up to 8 weeks post-operatively, 3 months, 6 months, 12 months, 24 months
Population: The overall number of patients participated in each interval differed from the number of patients that were evaluated for the body location measurements.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Back | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Right Hip Cross Leg Weakness | 6.1 score on a scale | Standard Deviation 37.1 |
| Back | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Left Hip Cross Leg Weakness | 16.8 score on a scale | Standard Deviation 41.1 |
| Back | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Left Hip Stairs Weakness | 6.1 score on a scale | Standard Deviation 38 |
| Back | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Flexing Left Hip Weakness | 7.8 score on a scale | Standard Deviation 37.9 |
| Back | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Left Groin Pain | -0.3 score on a scale | Standard Deviation 28.3 |
| Back | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Right Hip Stairs Weakness | 0.4 score on a scale | Standard Deviation 36.2 |
| Back | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Pain Above Right Knee | -15.3 score on a scale | Standard Deviation 33.8 |
| Back | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Extending Right Hip Weakness | -2.8 score on a scale | Standard Deviation 33.1 |
| Back | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Flexing Right Hip Weakness | -0.3 score on a scale | Standard Deviation 34.1 |
| Back | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Extending Left Hip Weakness | 8.6 score on a scale | Standard Deviation 39.7 |
| Back | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Right Groin Pain | -7.2 score on a scale | Standard Deviation 29.9 |
| Back | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Pain Above Left Knee | -3.9 score on a scale | Standard Deviation 28.6 |
| Left Hip | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Right Groin Pain | -15.1 score on a scale | Standard Deviation 33.4 |
| Left Hip | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Flexing Right Hip Weakness | -17.3 score on a scale | Standard Deviation 34.7 |
| Left Hip | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Flexing Left Hip Weakness | -10.6 score on a scale | Standard Deviation 39.7 |
| Left Hip | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Pain Above Left Knee | -14.3 score on a scale | Standard Deviation 38.2 |
| Left Hip | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Right Hip Stairs Weakness | -20.7 score on a scale | Standard Deviation 39.6 |
| Left Hip | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Pain Above Right Knee | -21.3 score on a scale | Standard Deviation 35.8 |
| Left Hip | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Right Hip Cross Leg Weakness | -13.4 score on a scale | Standard Deviation 39 |
| Left Hip | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Left Hip Stairs Weakness | -15.9 score on a scale | Standard Deviation 42.5 |
| Left Hip | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Extending Right Hip Weakness | -15.6 score on a scale | Standard Deviation 36.2 |
| Left Hip | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Left Groin Pain | -10.4 score on a scale | Standard Deviation 33.5 |
| Left Hip | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Left Hip Cross Leg Weakness | -8.2 score on a scale | Standard Deviation 42.7 |
| Left Hip | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Extending Left Hip Weakness | -7.4 score on a scale | Standard Deviation 40.1 |
| Right Hip | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Extending Left Hip Weakness | -14.0 score on a scale | Standard Deviation 30.1 |
| Right Hip | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Pain Above Left Knee | -20 score on a scale | Standard Deviation 34.3 |
| Right Hip | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Pain Above Right Knee | -26.9 score on a scale | Standard Deviation 33.9 |
| Right Hip | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Left Groin Pain | -11.8 score on a scale | Standard Deviation 30.8 |
| Right Hip | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Right Groin Pain | -15.7 score on a scale | Standard Deviation 31.6 |
| Right Hip | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Flexing Left Hip Weakness | -15.1 score on a scale | Standard Deviation 33.3 |
| Right Hip | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Flexing Right Hip Weakness | -17.6 score on a scale | Standard Deviation 34 |
| Right Hip | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Extending Right Hip Weakness | -16.2 score on a scale | Standard Deviation 36.5 |
| Right Hip | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Left Hip Stairs Weakness | -20.5 score on a scale | Standard Deviation 38.9 |
| Right Hip | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Right Hip Stairs Weakness | -24.3 score on a scale | Standard Deviation 37.7 |
| Right Hip | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Left Hip Cross Leg Weakness | -16.7 score on a scale | Standard Deviation 40.1 |
| Right Hip | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Right Hip Cross Leg Weakness | -21.6 score on a scale | Standard Deviation 36.5 |
| Left Leg | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Flexing Left Hip Weakness | -17.8 score on a scale | Standard Deviation 33.2 |
| Left Leg | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Right Hip Stairs Weakness | -29.7 score on a scale | Standard Deviation 36.4 |
| Left Leg | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Flexing Right Hip Weakness | -23.5 score on a scale | Standard Deviation 33.8 |
| Left Leg | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Pain Above Right Knee | -29.2 score on a scale | Standard Deviation 33.9 |
| Left Leg | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Extending Left Hip Weakness | -16.9 score on a scale | Standard Deviation 30.7 |
| Left Leg | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Left Hip Stairs Weakness | -24.7 score on a scale | Standard Deviation 36.8 |
| Left Leg | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Right Groin Pain | -19.9 score on a scale | Standard Deviation 33.1 |
| Left Leg | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Left Hip Cross Leg Weakness | -21.0 score on a scale | Standard Deviation 34.7 |
| Left Leg | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Left Groin Pain | -14.5 score on a scale | Standard Deviation 28.7 |
| Left Leg | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Right Hip Cross Leg Weakness | -25.2 score on a scale | Standard Deviation 35.8 |
| Left Leg | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Pain Above Left Knee | -18.7 score on a scale | Standard Deviation 33.8 |
| Left Leg | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Extending Right Hip Weakness | -24.4 score on a scale | Standard Deviation 32.3 |
| Right Leg | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Left Hip Stairs Weakness | -26.8 score on a scale | Standard Deviation 36.6 |
| Right Leg | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Flexing Right Hip Weakness | -24.7 score on a scale | Standard Deviation 31.7 |
| Right Leg | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Left Groin Pain | -15.1 score on a scale | Standard Deviation 31.1 |
| Right Leg | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Extending Left Hip Weakness | -16.8 score on a scale | Standard Deviation 33.4 |
| Right Leg | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Extending Right Hip Weakness | -24.4 score on a scale | Standard Deviation 33.1 |
| Right Leg | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Pain Above Right Knee | -31 score on a scale | Standard Deviation 31.4 |
| Right Leg | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Left Hip Cross Leg Weakness | -25.5 score on a scale | Standard Deviation 36.3 |
| Right Leg | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Pain Above Left Knee | -22.4 score on a scale | Standard Deviation 34.6 |
| Right Leg | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Right Hip Cross Leg Weakness | -27.8 score on a scale | Standard Deviation 32.4 |
| Right Leg | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Right Hip Stairs Weakness | -30.1 score on a scale | Standard Deviation 35.2 |
| Right Leg | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Flexing Left Hip Weakness | -20.0 score on a scale | Standard Deviation 32.2 |
| Right Leg | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Right Groin Pain | -20.3 score on a scale | Standard Deviation 31 |
| Overall | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Flexing Left Hip Weakness | -12.5 score on a scale | Standard Deviation 29.2 |
| Overall | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Right Hip Stairs Weakness | -27.8 score on a scale | Standard Deviation 35.5 |
| Overall | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Left Hip Cross Leg Weakness | -19.2 score on a scale | Standard Deviation 31.8 |
| Overall | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Right Hip Cross Leg Weakness | -25.6 score on a scale | Standard Deviation 32.8 |
| Overall | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Pain Above Right Knee | -31.2 score on a scale | Standard Deviation 31.8 |
| Overall | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Right Groin Pain | -23.2 score on a scale | Standard Deviation 30.5 |
| Overall | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Extending Left Hip Weakness | -11.0 score on a scale | Standard Deviation 30.6 |
| Overall | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Left Hip Stairs Weakness | -20.0 score on a scale | Standard Deviation 33.7 |
| Overall | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Pain Above Left Knee | -17.8 score on a scale | Standard Deviation 34 |
| Overall | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Left Groin Pain | -10.8 score on a scale | Standard Deviation 25.2 |
| Overall | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Flexing Right Hip Weakness | -20.4 score on a scale | Standard Deviation 34.1 |
| Overall | Change in Pain/Dysesthesia Score From Baseline (Pre-Operative) | Extending Right Hip Weakness | -22.4 score on a scale | Standard Deviation 34.9 |
Secondary
Change in Use of Narcotics Post-Surgery Compared to Baseline
The types and dosages of any narcotics taken by the patient post-surgery were documented.
Time frame: Pre-operative to 24 months
Population: All patients who participated in each interval were accounted for including the missing category
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Back | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Missing | 0 Participants |
| Back | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Intermittent short-acting narcotics | 21 Participants |
| Back | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Chronic daily long-acting narcotics | 16 Participants |
| Back | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | None | 15 Participants |
| Back | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | IV or injected narcotics | 0 Participants |
| Back | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Chronic daily long-acting narcotics | 1 Participants |
| Back | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Chronic daily short-acting narcotics | 30 Participants |
| Back | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | None | 103 Participants |
| Back | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Non-narcotics or NSAIDs | 14 Participants |
| Back | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Intermittent short-acting narcotics | 2 Participants |
| Back | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | IV or injected narcotics | 1 Participants |
| Back | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Missing | 0 Participants |
| Back | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Non-narcotics or NSAIDs | 42 Participants |
| Back | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Chronic daily short-acting narcotics | 5 Participants |
| Left Hip | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Chronic daily short-acting narcotics | 5 Participants |
| Left Hip | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | None | 97 Participants |
| Left Hip | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Non-narcotics or NSAIDs | 14 Participants |
| Left Hip | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | None | 15 Participants |
| Left Hip | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | IV or injected narcotics | 0 Participants |
| Left Hip | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Non-narcotics or NSAIDs | 20 Participants |
| Left Hip | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Intermittent short-acting narcotics | 38 Participants |
| Left Hip | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Chronic daily short-acting narcotics | 24 Participants |
| Left Hip | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Missing | 0 Participants |
| Left Hip | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Chronic daily long-acting narcotics | 2 Participants |
| Left Hip | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Chronic daily long-acting narcotics | 19 Participants |
| Left Hip | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Intermittent short-acting narcotics | 4 Participants |
| Left Hip | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | IV or injected narcotics | 6 Participants |
| Left Hip | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Missing | 0 Participants |
| Right Hip | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Chronic daily long-acting narcotics | 7 Participants |
| Right Hip | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Non-narcotics or NSAIDs | 25 Participants |
| Right Hip | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Chronic daily short-acting narcotics | 2 Participants |
| Right Hip | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | None | 23 Participants |
| Right Hip | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | IV or injected narcotics | 1 Participants |
| Right Hip | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Missing | 1 Participants |
| Right Hip | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | IV or injected narcotics | 1 Participants |
| Right Hip | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Non-narcotics or NSAIDs | 11 Participants |
| Right Hip | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Chronic daily short-acting narcotics | 20 Participants |
| Right Hip | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Missing | 1 Participants |
| Right Hip | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Intermittent short-acting narcotics | 6 Participants |
| Right Hip | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Chronic daily long-acting narcotics | 0 Participants |
| Right Hip | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Intermittent short-acting narcotics | 34 Participants |
| Right Hip | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | None | 90 Participants |
| Left Leg | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Missing | 0 Participants |
| Left Leg | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | None | 26 Participants |
| Left Leg | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Non-narcotics or NSAIDs | 28 Participants |
| Left Leg | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Intermittent short-acting narcotics | 27 Participants |
| Left Leg | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Chronic daily short-acting narcotics | 17 Participants |
| Left Leg | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Chronic daily long-acting narcotics | 6 Participants |
| Left Leg | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | IV or injected narcotics | 0 Participants |
| Left Leg | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Missing | 0 Participants |
| Left Leg | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | None | 79 Participants |
| Left Leg | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Non-narcotics or NSAIDs | 17 Participants |
| Left Leg | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Intermittent short-acting narcotics | 5 Participants |
| Left Leg | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Chronic daily short-acting narcotics | 2 Participants |
| Left Leg | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Chronic daily long-acting narcotics | 1 Participants |
| Left Leg | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | IV or injected narcotics | 0 Participants |
| Right Leg | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Intermittent short-acting narcotics | 7 Participants |
| Right Leg | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Chronic daily long-acting narcotics | 3 Participants |
| Right Leg | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Chronic daily long-acting narcotics | 0 Participants |
| Right Leg | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Missing | 3 Participants |
| Right Leg | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Intermittent short-acting narcotics | 16 Participants |
| Right Leg | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Chronic daily short-acting narcotics | 1 Participants |
| Right Leg | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | None | 30 Participants |
| Right Leg | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Non-narcotics or NSAIDs | 29 Participants |
| Right Leg | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | IV or injected narcotics | 0 Participants |
| Right Leg | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Missing | 3 Participants |
| Right Leg | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | None | 64 Participants |
| Right Leg | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | IV or injected narcotics | 1 Participants |
| Right Leg | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Non-narcotics or NSAIDs | 22 Participants |
| Right Leg | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Chronic daily short-acting narcotics | 15 Participants |
| Overall | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Non-narcotics or NSAIDs | 12 Participants |
| Overall | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | IV or injected narcotics | 1 Participants |
| Overall | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Missing | 0 Participants |
| Overall | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Intermittent short-acting narcotics | 1 Participants |
| Overall | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Chronic daily long-acting narcotics | 1 Participants |
| Overall | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Chronic daily short-acting narcotics | 2 Participants |
| Overall | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Chronic daily short-acting narcotics | 9 Participants |
| Overall | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Intermittent short-acting narcotics | 7 Participants |
| Overall | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Non-narcotics or NSAIDs | 14 Participants |
| Overall | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | Chronic daily long-acting narcotics | 0 Participants |
| Overall | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | None | 24 Participants |
| Overall | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | None | 41 Participants |
| Overall | Change in Use of Narcotics Post-Surgery Compared to Baseline | Non-Back Meds | IV or injected narcotics | 0 Participants |
| Overall | Change in Use of Narcotics Post-Surgery Compared to Baseline | Back Meds | Missing | 0 Participants |
Secondary
Change in Work/School Status Compared to Baseline
The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery was documented.
Time frame: Pre-operative to 24 months
Population: All patients who participated in each interval were accounted for including the missing category
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Back | Change in Work/School Status Compared to Baseline | Unemployed, unrelated to back/leg conditions | 16 Participants |
| Back | Change in Work/School Status Compared to Baseline | Not attending work/school by choice | 42 Participants |
| Back | Change in Work/School Status Compared to Baseline | Unable to go due to back/leg pain/conditions | 30 Participants |
| Back | Change in Work/School Status Compared to Baseline | Attending work/school with some restrictions | 25 Participants |
| Back | Change in Work/School Status Compared to Baseline | Attending work/school with no restrictions | 12 Participants |
| Back | Change in Work/School Status Compared to Baseline | Missing | 0 Participants |
| Left Hip | Change in Work/School Status Compared to Baseline | Not attending work/school by choice | 35 Participants |
| Left Hip | Change in Work/School Status Compared to Baseline | Attending work/school with some restrictions | 15 Participants |
| Left Hip | Change in Work/School Status Compared to Baseline | Missing | 1 Participants |
| Left Hip | Change in Work/School Status Compared to Baseline | Unemployed, unrelated to back/leg conditions | 25 Participants |
| Left Hip | Change in Work/School Status Compared to Baseline | Unable to go due to back/leg pain/conditions | 41 Participants |
| Left Hip | Change in Work/School Status Compared to Baseline | Attending work/school with no restrictions | 5 Participants |
| Right Hip | Change in Work/School Status Compared to Baseline | Missing | 1 Participants |
| Right Hip | Change in Work/School Status Compared to Baseline | Attending work/school with no restrictions | 14 Participants |
| Right Hip | Change in Work/School Status Compared to Baseline | Attending work/school with some restrictions | 14 Participants |
| Right Hip | Change in Work/School Status Compared to Baseline | Unable to go due to back/leg pain/conditions | 24 Participants |
| Right Hip | Change in Work/School Status Compared to Baseline | Unemployed, unrelated to back/leg conditions | 22 Participants |
| Right Hip | Change in Work/School Status Compared to Baseline | Not attending work/school by choice | 36 Participants |
| Left Leg | Change in Work/School Status Compared to Baseline | Attending work/school with some restrictions | 15 Participants |
| Left Leg | Change in Work/School Status Compared to Baseline | Not attending work/school by choice | 31 Participants |
| Left Leg | Change in Work/School Status Compared to Baseline | Unable to go due to back/leg pain/conditions | 18 Participants |
| Left Leg | Change in Work/School Status Compared to Baseline | Missing | 1 Participants |
| Left Leg | Change in Work/School Status Compared to Baseline | Attending work/school with no restrictions | 17 Participants |
| Left Leg | Change in Work/School Status Compared to Baseline | Unemployed, unrelated to back/leg conditions | 22 Participants |
| Right Leg | Change in Work/School Status Compared to Baseline | Unemployed, unrelated to back/leg conditions | 16 Participants |
| Right Leg | Change in Work/School Status Compared to Baseline | Attending work/school with no restrictions | 20 Participants |
| Right Leg | Change in Work/School Status Compared to Baseline | Not attending work/school by choice | 35 Participants |
| Right Leg | Change in Work/School Status Compared to Baseline | Unable to go due to back/leg pain/conditions | 16 Participants |
| Right Leg | Change in Work/School Status Compared to Baseline | Attending work/school with some restrictions | 8 Participants |
| Right Leg | Change in Work/School Status Compared to Baseline | Missing | 2 Participants |
| Overall | Change in Work/School Status Compared to Baseline | Attending work/school with some restrictions | 5 Participants |
| Overall | Change in Work/School Status Compared to Baseline | Unable to go due to back/leg pain/conditions | 10 Participants |
| Overall | Change in Work/School Status Compared to Baseline | Attending work/school with no restrictions | 12 Participants |
| Overall | Change in Work/School Status Compared to Baseline | Missing | 0 Participants |
| Overall | Change in Work/School Status Compared to Baseline | Not attending work/school by choice | 21 Participants |
| Overall | Change in Work/School Status Compared to Baseline | Unemployed, unrelated to back/leg conditions | 8 Participants |
Secondary
Estimated Blood Loss
The amount of blood loss over the entire length of the surgery, documented on the Anesthesia Record, was captured.
Time frame: During Operation
Population: 11 of 125 subjects did not have blood loss included. There were 12 staged procedures increasing the overall number of procedures to 126.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Back | Estimated Blood Loss | 76.5 Cubic Centimeters | Standard Deviation 78.9 |
Secondary
Length of Hospital Stay
The length of hospital stay from the date of hospital admission to the date of discharge was calculated.
Time frame: From admission to discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Back | Length of Hospital Stay | 4.5 Days | Standard Deviation 3.3 |
Secondary
Number of Participants With Abnormal Neuromonitoring System Results
Abnormal result(s) of neuromonitoring systems (Train of Four, Electromyography (EMG), Triggered EMG, Somato Sensory Evoked Potential (SSEP) and Motor Evoked Potential (MEP)) utilized during the surgery were captured.
Time frame: During operation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Back | Number of Participants With Abnormal Neuromonitoring System Results | 1 Participants |
| Left Hip | Number of Participants With Abnormal Neuromonitoring System Results | 0 Participants |
| Right Hip | Number of Participants With Abnormal Neuromonitoring System Results | 0 Participants |
| Left Leg | Number of Participants With Abnormal Neuromonitoring System Results | 0 Participants |
| Right Leg | Number of Participants With Abnormal Neuromonitoring System Results | 0 Participants |
Secondary
Odom's Criteria
At the 24 month follow-up visit, the Investigator rated the clinical disposition of each study subject according to Odom's Criteria as follows: Excellent: all pre-operative symptoms relieved, able to carry out daily occupations without impairment. Good: minimum persistence of pre-operative symptoms, able to carry out daily occupations without significant interference. Fair/Satisfactory: relief of some pre-operative symptoms but physical activity is significantly limited. Poor: symptoms or signs unchanged or worse.
Time frame: 24 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Back | Odom's Criteria | Excellent | 33 Participants |
| Back | Odom's Criteria | Good | 17 Participants |
| Back | Odom's Criteria | Fair/Satisfactory | 5 Participants |
| Back | Odom's Criteria | Not Reported | 1 Participants |
Secondary
Patient Satisfaction
At the 12 month and 24 month follow-up visits, subjects were asked whether they were satisfied with the outcome of their surgery (Yes/No) and whether they would repeat the operation (Yes/No).
Time frame: 12 month and 24 month
Population: Patient self-assessment of the procedure at 12M and 24M
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Back | Patient Satisfaction | Satisfied | Yes | 80 Participants |
| Back | Patient Satisfaction | Satisfied | No | 11 Participants |
| Back | Patient Satisfaction | Satisfied | Not Reported | 6 Participants |
| Back | Patient Satisfaction | Repeat Procedure | Yes | 80 Participants |
| Back | Patient Satisfaction | Repeat Procedure | No | 11 Participants |
| Back | Patient Satisfaction | Repeat Procedure | Not Reported | 6 Participants |
| Left Hip | Patient Satisfaction | Repeat Procedure | No | 5 Participants |
| Left Hip | Patient Satisfaction | Satisfied | Yes | 51 Participants |
| Left Hip | Patient Satisfaction | Repeat Procedure | Yes | 51 Participants |
| Left Hip | Patient Satisfaction | Satisfied | No | 5 Participants |
| Left Hip | Patient Satisfaction | Repeat Procedure | Not Reported | 0 Participants |
| Left Hip | Patient Satisfaction | Satisfied | Not Reported | 0 Participants |
Secondary
Radiographic Assessments
Quantitative and qualitative radiographic assessment of the pre and post-operative AP, and Lateral, Flexion/Extension images were performed. Radiographic and qualitative assessments performed include: * Device Condition: looks at both the cage inside the vertebrae and the hardware outside the vertebrae. It looks at whether or not the device is intact or not (subsidence or migration) * Fusion/Non-fusion: whether bone has grown within the space between the spinal vertebrae. If fusion occurs, it results in Bony Bridging
Time frame: 12 mo to 24 mo
Population: The numbers are different from the overall number analyzed due to the different number of people who participated in each visit's radiographic analysis
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Back | Radiographic Assessments | 12 Month Cage Condition | Not Applicable | 0 Participants |
| Back | Radiographic Assessments | 12 Month Hardware Condition | Intact | 48 Participants |
| Back | Radiographic Assessments | 24 Month Fusion | Other | 0 Participants |
| Back | Radiographic Assessments | 24 Month Cage Condition | Fracture | 0 Participants |
| Back | Radiographic Assessments | 12 Month Hardware Condition | Loosening | 0 Participants |
| Back | Radiographic Assessments | 24 Month Fusion | Migration | 0 Participants |
| Back | Radiographic Assessments | 24 Month Fusion | Bridging / Fusion | 29 Participants |
| Back | Radiographic Assessments | 12 Month Hardware Condition | Fracture | 0 Participants |
| Back | Radiographic Assessments | 12 Month Cage Condition | Other | 0 Participants |
| Back | Radiographic Assessments | 24 Month Cage Condition | Not Applicable | 0 Participants |
| Back | Radiographic Assessments | 12 Month Hardware Condition | Not Applicable | 11 Participants |
| Back | Radiographic Assessments | 24 Month Fusion | Subsidence | 2 Participants |
| Back | Radiographic Assessments | 12 Month Cage Condition | Unable to Assess | 0 Participants |
| Back | Radiographic Assessments | 12 Month Hardware Condition | Unable to Assess | 1 Participants |
| Back | Radiographic Assessments | 24 Month Cage Condition | Unable to Assess | 0 Participants |
| Back | Radiographic Assessments | 12 Month Fusion | Unable to Assess | 15 Participants |
| Back | Radiographic Assessments | 12 Month Hardware Condition | Subsidence | 0 Participants |
| Back | Radiographic Assessments | 24 Month Cage Condition | Absent | 0 Participants |
| Back | Radiographic Assessments | 12 Month Cage Condition | Intact | 58 Participants |
| Back | Radiographic Assessments | 12 Month Hardware Condition | Migration | 0 Participants |
| Back | Radiographic Assessments | 24 Month Cage Condition | Subsidence | 0 Participants |
| Back | Radiographic Assessments | 24 Month Fusion | Unable to Assess | 0 Participants |
| Back | Radiographic Assessments | 12 Month Fusion | Subsidence & Migration | 0 Participants |
| Back | Radiographic Assessments | 12 Month Hardware Condition | Subsidence & Migration | 0 Participants |
| Back | Radiographic Assessments | 12 Month Hardware Condition | Absent | 0 Participants |
| Back | Radiographic Assessments | 24 Month Cage Condition | Migration | 0 Participants |
| Back | Radiographic Assessments | 12 Month Hardware Condition | Other | 0 Participants |
| Back | Radiographic Assessments | 24 Month Cage Condition | Partial Consolidation | 0 Participants |
| Back | Radiographic Assessments | 12 Month Cage Condition | Subsidence | 2 Participants |
| Back | Radiographic Assessments | 24 Month Hardware Condition | Absent | 0 Participants |
| Back | Radiographic Assessments | 12 Month Cage Condition | Fracture | 0 Participants |
| Back | Radiographic Assessments | 12 Month Fusion | Subsidence | 0 Participants |
| Back | Radiographic Assessments | 24 Month Hardware Condition | Partial Consolidation | 0 Participants |
| Back | Radiographic Assessments | 12 Month Cage Condition | Migration | 0 Participants |
| Back | Radiographic Assessments | 24 Month Hardware Condition | Bridging / Fusion | 0 Participants |
| Back | Radiographic Assessments | 24 Month Cage Condition | Subsidence & Migration | 0 Participants |
| Back | Radiographic Assessments | 12 Month Fusion | Migration | 0 Participants |
| Back | Radiographic Assessments | 24 Month Hardware Condition | Intact | 28 Participants |
| Back | Radiographic Assessments | 24 Month Fusion | Subsidence & Migration | 0 Participants |
| Back | Radiographic Assessments | 24 Month Fusion | Intact | 0 Participants |
| Back | Radiographic Assessments | 24 Month Hardware Condition | Loosening | 0 Participants |
| Back | Radiographic Assessments | 24 Month Cage Condition | Bridging / Fusion | 0 Participants |
| Back | Radiographic Assessments | 24 Month Cage Condition | Other | 0 Participants |
| Back | Radiographic Assessments | 24 Month Hardware Condition | Fracture | 0 Participants |
| Back | Radiographic Assessments | 12 Month Cage Condition | Loosening | 0 Participants |
| Back | Radiographic Assessments | 12 Month Hardware Condition | Partial Consolidation | 0 Participants |
| Back | Radiographic Assessments | 24 Month Hardware Condition | Not Applicable | 3 Participants |
| Back | Radiographic Assessments | 12 Month Fusion | Absent | 2 Participants |
| Back | Radiographic Assessments | 24 Month Fusion | Loosening | 0 Participants |
| Back | Radiographic Assessments | 24 Month Hardware Condition | Unable to Assess | 0 Participants |
| Back | Radiographic Assessments | 12 Month Fusion | Other | 0 Participants |
| Back | Radiographic Assessments | 24 Month Cage Condition | Intact | 31 Participants |
| Back | Radiographic Assessments | 24 Month Hardware Condition | Subsidence | 0 Participants |
| Back | Radiographic Assessments | 12 Month Fusion | Partial Consolidation | 10 Participants |
| Back | Radiographic Assessments | 12 Month Fusion | Fracture | 0 Participants |
| Back | Radiographic Assessments | 24 Month Hardware Condition | Migration | 0 Participants |
| Back | Radiographic Assessments | 12 Month Cage Condition | Subsidence & Migration | 0 Participants |
| Back | Radiographic Assessments | 24 Month Fusion | Fracture | 0 Participants |
| Back | Radiographic Assessments | 24 Month Hardware Condition | Subsidence & Migration | 0 Participants |
| Back | Radiographic Assessments | 24 Month Fusion | Partial Consolidation | 0 Participants |
| Back | Radiographic Assessments | 12 Month Fusion | Bridging / Fusion | 33 Participants |
| Back | Radiographic Assessments | 24 Month Hardware Condition | Other | 0 Participants |
| Back | Radiographic Assessments | 12 Month Hardware Condition | Bridging / Fusion | 0 Participants |
| Back | Radiographic Assessments | 12 Month Fusion | Intact | 0 Participants |
| Back | Radiographic Assessments | 12 Month Cage Condition | Absent | 0 Participants |
| Back | Radiographic Assessments | 24 Month Fusion | Absent | 0 Participants |
| Back | Radiographic Assessments | 24 Month Fusion | Not Applicable | 0 Participants |
| Back | Radiographic Assessments | 12 Month Cage Condition | Partial Consolidation | 0 Participants |
| Back | Radiographic Assessments | 24 Month Cage Condition | Loosening | 0 Participants |
| Back | Radiographic Assessments | 12 Month Fusion | Loosening | 0 Participants |
| Back | Radiographic Assessments | 12 Month Cage Condition | Bridging / Fusion | 0 Participants |
| Back | Radiographic Assessments | 12 Month Fusion | Not Applicable | 0 Participants |
| Left Hip | Radiographic Assessments | 12 Month Cage Condition | Bridging / Fusion | 0 Participants |
| Left Hip | Radiographic Assessments | 12 Month Cage Condition | Intact | 16 Participants |
| Left Hip | Radiographic Assessments | 12 Month Cage Condition | Loosening | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Fusion | Unable to Assess | 0 Participants |
| Left Hip | Radiographic Assessments | 12 Month Cage Condition | Fracture | 0 Participants |
| Left Hip | Radiographic Assessments | 12 Month Cage Condition | Unable to Assess | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Fusion | Subsidence | 0 Participants |
| Left Hip | Radiographic Assessments | 12 Month Cage Condition | Subsidence | 1 Participants |
| Left Hip | Radiographic Assessments | 12 Month Cage Condition | Migration | 0 Participants |
| Left Hip | Radiographic Assessments | 12 Month Fusion | Other | 0 Participants |
| Left Hip | Radiographic Assessments | 12 Month Cage Condition | Subsidence & Migration | 1 Participants |
| Left Hip | Radiographic Assessments | 12 Month Cage Condition | Other | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Fusion | Migration | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Cage Condition | Absent | 0 Participants |
| Left Hip | Radiographic Assessments | 12 Month Fusion | Not Applicable | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Cage Condition | Partial Consolidation | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Cage Condition | Bridging / Fusion | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Fusion | Subsidence & Migration | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Cage Condition | Intact | 13 Participants |
| Left Hip | Radiographic Assessments | 24 Month Cage Condition | Loosening | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Cage Condition | Fracture | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Fusion | Other | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Cage Condition | Not Applicable | 0 Participants |
| Left Hip | Radiographic Assessments | 12 Month Fusion | Loosening | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Cage Condition | Unable to Assess | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Fusion | Absent | 1 Participants |
| Left Hip | Radiographic Assessments | 24 Month Cage Condition | Subsidence | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Cage Condition | Migration | 0 Participants |
| Left Hip | Radiographic Assessments | 12 Month Hardware Condition | Absent | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Cage Condition | Subsidence & Migration | 0 Participants |
| Left Hip | Radiographic Assessments | 12 Month Fusion | Fracture | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Cage Condition | Other | 0 Participants |
| Left Hip | Radiographic Assessments | 12 Month Fusion | Absent | 3 Participants |
| Left Hip | Radiographic Assessments | 12 Month Hardware Condition | Partial Consolidation | 0 Participants |
| Left Hip | Radiographic Assessments | 12 Month Fusion | Partial Consolidation | 2 Participants |
| Left Hip | Radiographic Assessments | 12 Month Fusion | Intact | 0 Participants |
| Left Hip | Radiographic Assessments | 12 Month Hardware Condition | Bridging / Fusion | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Fusion | Partial Consolidation | 0 Participants |
| Left Hip | Radiographic Assessments | 12 Month Hardware Condition | Intact | 17 Participants |
| Left Hip | Radiographic Assessments | 12 Month Fusion | Subsidence | 0 Participants |
| Left Hip | Radiographic Assessments | 12 Month Hardware Condition | Loosening | 1 Participants |
| Left Hip | Radiographic Assessments | 12 Month Hardware Condition | Fracture | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Fusion | Bridging / Fusion | 12 Participants |
| Left Hip | Radiographic Assessments | 12 Month Hardware Condition | Not Applicable | 0 Participants |
| Left Hip | Radiographic Assessments | 12 Month Fusion | Bridging / Fusion | 11 Participants |
| Left Hip | Radiographic Assessments | 12 Month Hardware Condition | Unable to Assess | 0 Participants |
| Left Hip | Radiographic Assessments | 12 Month Hardware Condition | Subsidence | 0 Participants |
| Left Hip | Radiographic Assessments | 12 Month Fusion | Unable to Assess | 2 Participants |
| Left Hip | Radiographic Assessments | 12 Month Hardware Condition | Migration | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Hardware Condition | Partial Consolidation | 0 Participants |
| Left Hip | Radiographic Assessments | 12 Month Hardware Condition | Subsidence & Migration | 0 Participants |
| Left Hip | Radiographic Assessments | 12 Month Cage Condition | Not Applicable | 0 Participants |
| Left Hip | Radiographic Assessments | 12 Month Hardware Condition | Other | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Hardware Condition | Absent | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Hardware Condition | Bridging / Fusion | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Hardware Condition | Intact | 12 Participants |
| Left Hip | Radiographic Assessments | 24 Month Hardware Condition | Loosening | 1 Participants |
| Left Hip | Radiographic Assessments | 24 Month Fusion | Intact | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Hardware Condition | Fracture | 0 Participants |
| Left Hip | Radiographic Assessments | 12 Month Fusion | Migration | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Hardware Condition | Not Applicable | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Hardware Condition | Unable to Assess | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Fusion | Loosening | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Hardware Condition | Subsidence | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Hardware Condition | Migration | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Hardware Condition | Subsidence & Migration | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Fusion | Fracture | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Hardware Condition | Other | 0 Participants |
| Left Hip | Radiographic Assessments | 12 Month Fusion | Subsidence & Migration | 0 Participants |
| Left Hip | Radiographic Assessments | 12 Month Cage Condition | Absent | 0 Participants |
| Left Hip | Radiographic Assessments | 12 Month Cage Condition | Partial Consolidation | 0 Participants |
| Left Hip | Radiographic Assessments | 24 Month Fusion | Not Applicable | 0 Participants |
| Right Hip | Radiographic Assessments | 24 Month Cage Condition | Not Applicable | 0 Participants |
| Right Hip | Radiographic Assessments | 12 Month Fusion | Loosening | 0 Participants |
| Right Hip | Radiographic Assessments | 12 Month Fusion | Fracture | 0 Participants |
| Right Hip | Radiographic Assessments | 12 Month Fusion | Unable to Assess | 2 Participants |
| Right Hip | Radiographic Assessments | 12 Month Fusion | Not Applicable | 0 Participants |
| Right Hip | Radiographic Assessments | 12 Month Fusion | Subsidence | 0 Participants |
| Right Hip | Radiographic Assessments | 12 Month Fusion | Migration | 0 Participants |
| Right Hip | Radiographic Assessments | 12 Month Fusion | Subsidence & Migration | 0 Participants |
| Right Hip | Radiographic Assessments | 12 Month Fusion | Other | 0 Participants |
| Right Hip | Radiographic Assessments | 24 Month Fusion | Absent | 1 Participants |
| Right Hip | Radiographic Assessments | 24 Month Fusion | Partial Consolidation | 0 Participants |
| Right Hip | Radiographic Assessments | 12 Month Cage Condition | Subsidence | 1 Participants |
| Right Hip | Radiographic Assessments | 24 Month Fusion | Bridging / Fusion | 12 Participants |
| Right Hip | Radiographic Assessments | 24 Month Fusion | Intact | 0 Participants |
| Right Hip | Radiographic Assessments | 24 Month Fusion | Loosening | 0 Participants |
| Right Hip | Radiographic Assessments | 24 Month Fusion | Fracture | 0 Participants |
| Right Hip | Radiographic Assessments | 24 Month Fusion | Not Applicable | 0 Participants |
| Right Hip | Radiographic Assessments | 24 Month Fusion | Unable to Assess | 0 Participants |
| Right Hip | Radiographic Assessments | 24 Month Fusion | Subsidence | 0 Participants |
| Right Hip | Radiographic Assessments | 24 Month Fusion | Migration | 0 Participants |
| Right Hip | Radiographic Assessments | 24 Month Fusion | Subsidence & Migration | 0 Participants |
| Right Hip | Radiographic Assessments | 24 Month Fusion | Other | 0 Participants |
| Right Hip | Radiographic Assessments | 12 Month Hardware Condition | Absent | 0 Participants |
| Right Hip | Radiographic Assessments | 12 Month Hardware Condition | Partial Consolidation | 0 Participants |
| Right Hip | Radiographic Assessments | 12 Month Hardware Condition | Bridging / Fusion | 0 Participants |
| Right Hip | Radiographic Assessments | 12 Month Hardware Condition | Intact | 17 Participants |
| Right Hip | Radiographic Assessments | 12 Month Hardware Condition | Loosening | 1 Participants |
| Right Hip | Radiographic Assessments | 12 Month Hardware Condition | Fracture | 0 Participants |
| Right Hip | Radiographic Assessments | 12 Month Hardware Condition | Not Applicable | 0 Participants |
| Right Hip | Radiographic Assessments | 12 Month Hardware Condition | Unable to Assess | 0 Participants |
| Right Hip | Radiographic Assessments | 12 Month Hardware Condition | Subsidence | 0 Participants |
| Right Hip | Radiographic Assessments | 12 Month Hardware Condition | Migration | 0 Participants |
| Right Hip | Radiographic Assessments | 12 Month Hardware Condition | Subsidence & Migration | 0 Participants |
| Right Hip | Radiographic Assessments | 12 Month Hardware Condition | Other | 0 Participants |
| Right Hip | Radiographic Assessments | 24 Month Hardware Condition | Absent | 0 Participants |
| Right Hip | Radiographic Assessments | 24 Month Hardware Condition | Partial Consolidation | 0 Participants |
| Right Hip | Radiographic Assessments | 24 Month Hardware Condition | Bridging / Fusion | 0 Participants |
| Right Hip | Radiographic Assessments | 24 Month Hardware Condition | Intact | 12 Participants |
| Right Hip | Radiographic Assessments | 24 Month Hardware Condition | Loosening | 1 Participants |
| Right Hip | Radiographic Assessments | 24 Month Hardware Condition | Fracture | 0 Participants |
| Right Hip | Radiographic Assessments | 24 Month Hardware Condition | Not Applicable | 0 Participants |
| Right Hip | Radiographic Assessments | 24 Month Hardware Condition | Unable to Assess | 0 Participants |
| Right Hip | Radiographic Assessments | 24 Month Hardware Condition | Subsidence | 0 Participants |
| Right Hip | Radiographic Assessments | 24 Month Hardware Condition | Migration | 0 Participants |
| Right Hip | Radiographic Assessments | 24 Month Hardware Condition | Subsidence & Migration | 0 Participants |
| Right Hip | Radiographic Assessments | 24 Month Hardware Condition | Other | 0 Participants |
| Right Hip | Radiographic Assessments | 12 Month Cage Condition | Absent | 0 Participants |
| Right Hip | Radiographic Assessments | 12 Month Cage Condition | Partial Consolidation | 0 Participants |
| Right Hip | Radiographic Assessments | 12 Month Cage Condition | Bridging / Fusion | 0 Participants |
| Right Hip | Radiographic Assessments | 12 Month Cage Condition | Intact | 15 Participants |
| Right Hip | Radiographic Assessments | 12 Month Cage Condition | Loosening | 0 Participants |
| Right Hip | Radiographic Assessments | 12 Month Cage Condition | Fracture | 0 Participants |
| Right Hip | Radiographic Assessments | 12 Month Cage Condition | Not Applicable | 0 Participants |
| Right Hip | Radiographic Assessments | 12 Month Cage Condition | Unable to Assess | 0 Participants |
| Right Hip | Radiographic Assessments | 12 Month Cage Condition | Migration | 1 Participants |
| Right Hip | Radiographic Assessments | 12 Month Cage Condition | Subsidence & Migration | 0 Participants |
| Right Hip | Radiographic Assessments | 12 Month Cage Condition | Other | 1 Participants |
| Right Hip | Radiographic Assessments | 24 Month Cage Condition | Absent | 0 Participants |
| Right Hip | Radiographic Assessments | 24 Month Cage Condition | Partial Consolidation | 0 Participants |
| Right Hip | Radiographic Assessments | 24 Month Cage Condition | Bridging / Fusion | 0 Participants |
| Right Hip | Radiographic Assessments | 24 Month Cage Condition | Intact | 11 Participants |
| Right Hip | Radiographic Assessments | 24 Month Cage Condition | Loosening | 0 Participants |
| Right Hip | Radiographic Assessments | 24 Month Cage Condition | Fracture | 0 Participants |
| Right Hip | Radiographic Assessments | 24 Month Cage Condition | Unable to Assess | 0 Participants |
| Right Hip | Radiographic Assessments | 24 Month Cage Condition | Subsidence | 1 Participants |
| Right Hip | Radiographic Assessments | 24 Month Cage Condition | Migration | 0 Participants |
| Right Hip | Radiographic Assessments | 24 Month Cage Condition | Subsidence & Migration | 0 Participants |
| Right Hip | Radiographic Assessments | 24 Month Cage Condition | Other | 1 Participants |
| Right Hip | Radiographic Assessments | 12 Month Fusion | Absent | 3 Participants |
| Right Hip | Radiographic Assessments | 12 Month Fusion | Partial Consolidation | 2 Participants |
| Right Hip | Radiographic Assessments | 12 Month Fusion | Bridging / Fusion | 11 Participants |
| Right Hip | Radiographic Assessments | 12 Month Fusion | Intact | 0 Participants |
Secondary
Surgery Time
The length of the surgical procedure from the initial incision to final closure were captured from the Anesthesia Record.
Time frame: During operation.
Population: 3 of 125 subjects did not have surgery time included. There were 12 staged procedures increasing the overall number of procedures to 134
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Back | Surgery Time | 142 Minutes | Standard Deviation 62.7 |