Adolescent Idiopathic Scoliosis
Conditions
Keywords
Scoliosis, Spinal Curvatures, Spinal Diseases, Adolescent Idiopathic Scoliosis, Spinal Deformity
Brief summary
To evaluate the restoration and maintenance of thoracic kyphosis and coronal curve correction demonstrated through the surgical implantation of the K2M MESA Rail™ Deformity System as compared to literature reported outcomes for standard Cobalt Chrome (CoCr) rod systems in the treatment of Adolescent Idiopathic Scoliosis (AIS).
Detailed description
Patients treated with the Ø5.5mm or Ø4.5mm MESA Rail™ Deformity System that had: Diagnosis of AIS requiring surgical treatment for selective non-cervical fusion with a minimum of five (5) instrumented vertebrae between T1-S1 as confirmed by patient history and radiographic studies. AIS cases must be classified as a Lenke type 1 or type 2 curve (lumbar modifiers and thoracic sagittal profiles will be noted but not restrictive). Age at time of surgery of ≥ 11 years old and ≤ 21 years old.
Interventions
DEVICEMESA Rail™ Deformity System
MESA Rail™ (cross-sectioned rod) with MESA pedicle screws compared to traditional rod use in the literature
Sponsors
K2M, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
11 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of AIS requiring surgical treatment for selective thoracic/lumbar fusion with a minimum of five (5) instrumented vertebrae between T1-S1 as confirmed by patient history and radiographic studies. AIS cases must be classified as a Lenke type 1 or type 2 curve. No cervical vertebrae are to be incorporated into the construct. * Willingness and ability to comply with the requirements of the protocol including follow-up requirements. * Willing and able to sign a study specific informed consent form or, in the case of a patient who is a minor, provide assent and the minor patient's parent/legal guardian provides written consent to participate. * Age range of ≥ 11 years old and ≤ 21 years old at time of surgery.
Exclusion criteria
* Previous anterior or posterior spine surgery at the index levels. * Previous posterior spine surgery (e.g., posterior element decompression) that destabilizes the cervical/thoracic/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 thoracic or 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 or cobalt chrome. * Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia. * Insulin-dependent type 1 or type 2 diabetes. * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Thoracic Kyphosis and Coronal Curve Correction on X-ray at 24 Months | Baseline (up to 90 days before surgery), 24 months | Restoration and maintenance of thoracic kyphosis and coronal curve correction. Thoracic kyphosis (Coronal Curve): measurement of curvature from the upper endplate of T4 to the lower endplate of T12. |
| Number of Participants With Adverse Events | Up to 24 months | Number of participants with SAE and AE for the various intervals |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 12 months and 24 months | 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). |
| Investigator's Rating of Subject's Clinical Disposition Using 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 worsened. |
| Length of Surgery Time | During surgery | The length of the surgical procedure from the initial incision to final closure were captured. |
| Length of Anesthesia Time | During surgery | The length of time the patient is under anesthesia was captured. |
| Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months | Baseline (up to 90 days before surgery), 24 months | Evaluation of the improvement of the Back VAS and Hip/Leg VAS (assessed together) 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 - 100mm with the 100mm accounting for the highest level of pain. |
| Length of Hospital Stay | Admission to Discharge | The length of the hospital stay from the date of admission to the date of discharge. |
| Change in Percentage of Participants Able to Return to Work/School | Pre-Op 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 by looking at the change in percentage of participants who were able to return to work without any restrictions |
| Use of Narcotics Post-surgery | Pre-Op to 24 months | The types and dosages of any narcotics taken by the patient pre- and post-surgery was documented. |
| Estimated Blood Loss | During surgery | The amount of blood loss over the entire length of the surgery was captured. |
| Change From Baseline in Quality of Life Scores on the SRS-22r at 24 Months | Baseline (up to 90 days before surgery), 24 months | The Revised Scoliosis Research Society-22 (SRS-22r) is a specific questionnaire for spine conditions. It is applied to patients with idiopathic scoliosis, whose conditions and treatments have a great impact on their quality of life. The SRS 22r was created and revised with the purpose of evaluating this impact from the patient's point of view. The reviewed version contains 22 questions distributed into five domains: function/activity (FA), pain (P), self- image/appearance (SA), mental health (MH) and satisfaction with treatment (ST). The scores vary from 1 to 5 in which 5 is the best health quality of life of patients. |
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. | 188 |
| Total | 188 |
Baseline characteristics
| Characteristic | Demographics and Baseline Characteristics |
|---|---|
| Age, Categorical <=18 years | 180 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 14.65 years STANDARD_DEVIATION 2.16 |
| Body Mass Index (BMI) | 21.43 kg/m^2 STANDARD_DEVIATION 4.66 |
| Height | 160.4 cm STANDARD_DEVIATION 10.8 |
| 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 Australia | 14 participants |
| Region of Enrollment New Zealand | 4 participants |
| Region of Enrollment United States | 170 participants |
| Sex: Female, Male Female | 139 Participants |
| Sex: Female, Male Male | 49 Participants |
| Tobacco Use Currently Use | 1 Participants |
| Tobacco Use Never | 186 Participants |
| Tobacco Use Quit | 1 Participants |
| Weight | 55.3 kg STANDARD_DEVIATION 13.53 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 188 |
| other Total, other adverse events | 93 / 188 |
| serious Total, serious adverse events | 17 / 188 |
Outcome results
Primary
Change From Baseline in Thoracic Kyphosis and Coronal Curve Correction on X-ray at 24 Months
Restoration and maintenance of thoracic kyphosis and coronal curve correction. Thoracic kyphosis (Coronal Curve): measurement of curvature from the upper endplate of T4 to the lower endplate of T12.
Time frame: Baseline (up to 90 days before surgery), 24 months
Population: 98 of the 99 participants who returned at 24 Months had the thoracic kyphosis measurement.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Patients | Change From Baseline in Thoracic Kyphosis and Coronal Curve Correction on X-ray at 24 Months | -3.84 degrees |
Primary
Number of Participants With Adverse Events
Number of participants with SAE and AE for the various intervals
Time frame: Up to 24 months
Population: This is an analysis of the number of participants that reported any form of adverse event. Overall participants with any AE or SAE. 5 of the 17 SAE participants did not experience a non-SAE events. The other 12 participants had events in both categories. The study did not establish a frequency threshold, therefore, all AEs are listed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients | Number of Participants With Adverse Events | Any AE : Procedure Related | 44 participants |
| All Patients | Number of Participants With Adverse Events | Any SAE : Severe | 4 participants |
| All Patients | Number of Participants With Adverse Events | Any SAE : Mild | 3 participants |
| All Patients | Number of Participants With Adverse Events | Any SAE : Moderate | 4 participants |
| All Patients | Number of Participants With Adverse Events | Any SAE | 10 participants |
| All Patients | Number of Participants With Adverse Events | Any AE : Mild | 44 participants |
| All Patients | Number of Participants With Adverse Events | Any AE : Moderate | 19 participants |
| All Patients | Number of Participants With Adverse Events | Any AE : Severe | 5 participants |
| All Patients | Number of Participants With Adverse Events | Any AE | 62 participants |
| All Patients | Number of Participants With Adverse Events | Any SAE : Device Related | 2 participants |
| All Patients | Number of Participants With Adverse Events | Any AE : Device Related | 16 participants |
| All Patients | Number of Participants With Adverse Events | Any SAE : Procedure Related | 8 participants |
| Post-Operative to 3 Months | Number of Participants With Adverse Events | Any AE : Severe | 1 participants |
| Post-Operative to 3 Months | Number of Participants With Adverse Events | Any SAE : Procedure Related | 0 participants |
| Post-Operative to 3 Months | Number of Participants With Adverse Events | Any AE : Mild | 6 participants |
| Post-Operative to 3 Months | Number of Participants With Adverse Events | Any SAE : Moderate | 0 participants |
| Post-Operative to 3 Months | Number of Participants With Adverse Events | Any SAE : Mild | 0 participants |
| Post-Operative to 3 Months | Number of Participants With Adverse Events | Any AE | 7 participants |
| Post-Operative to 3 Months | Number of Participants With Adverse Events | Any AE : Moderate | 1 participants |
| Post-Operative to 3 Months | Number of Participants With Adverse Events | Any AE : Procedure Related | 0 participants |
| Post-Operative to 3 Months | Number of Participants With Adverse Events | Any SAE | 1 participants |
| Post-Operative to 3 Months | Number of Participants With Adverse Events | Any AE : Device Related | 0 participants |
| Post-Operative to 3 Months | Number of Participants With Adverse Events | Any SAE : Device Related | 0 participants |
| Post-Operative to 3 Months | Number of Participants With Adverse Events | Any SAE : Severe | 1 participants |
| 3 to 6 Months | Number of Participants With Adverse Events | Any SAE | 0 participants |
| 3 to 6 Months | Number of Participants With Adverse Events | Any AE : Moderate | 4 participants |
| 3 to 6 Months | Number of Participants With Adverse Events | Any AE : Procedure Related | 12 participants |
| 3 to 6 Months | Number of Participants With Adverse Events | Any AE : Mild | 17 participants |
| 3 to 6 Months | Number of Participants With Adverse Events | Any SAE : Mild | 0 participants |
| 3 to 6 Months | Number of Participants With Adverse Events | Any SAE : Device Related | 0 participants |
| 3 to 6 Months | Number of Participants With Adverse Events | Any AE | 21 participants |
| 3 to 6 Months | Number of Participants With Adverse Events | Any SAE : Severe | 0 participants |
| 3 to 6 Months | Number of Participants With Adverse Events | Any SAE : Procedure Related | 0 participants |
| 3 to 6 Months | Number of Participants With Adverse Events | Any SAE : Moderate | 0 participants |
| 3 to 6 Months | Number of Participants With Adverse Events | Any AE : Severe | 0 participants |
| 3 to 6 Months | Number of Participants With Adverse Events | Any AE : Device Related | 3 participants |
| 6 to 12 Months | Number of Participants With Adverse Events | Any AE : Moderate | 5 participants |
| 6 to 12 Months | Number of Participants With Adverse Events | Any AE : Mild | 20 participants |
| 6 to 12 Months | Number of Participants With Adverse Events | Any AE : Severe | 1 participants |
| 6 to 12 Months | Number of Participants With Adverse Events | Any SAE | 4 participants |
| 6 to 12 Months | Number of Participants With Adverse Events | Any SAE : Severe | 1 participants |
| 6 to 12 Months | Number of Participants With Adverse Events | Any SAE : Moderate | 2 participants |
| 6 to 12 Months | Number of Participants With Adverse Events | Any AE | 25 participants |
| 6 to 12 Months | Number of Participants With Adverse Events | Any AE : Procedure Related | 9 participants |
| 6 to 12 Months | Number of Participants With Adverse Events | Any AE : Device Related | 6 participants |
| 6 to 12 Months | Number of Participants With Adverse Events | Any SAE : Procedure Related | 1 participants |
| 6 to 12 Months | Number of Participants With Adverse Events | Any SAE : Device Related | 1 participants |
| 6 to 12 Months | Number of Participants With Adverse Events | Any SAE : Mild | 1 participants |
| 12 to 24+ Months | Number of Participants With Adverse Events | Any AE : Device Related | 7 participants |
| 12 to 24+ Months | Number of Participants With Adverse Events | Any SAE | 3 participants |
| 12 to 24+ Months | Number of Participants With Adverse Events | Any SAE : Mild | 1 participants |
| 12 to 24+ Months | Number of Participants With Adverse Events | Any AE : Mild | 29 participants |
| 12 to 24+ Months | Number of Participants With Adverse Events | Any SAE : Device Related | 2 participants |
| 12 to 24+ Months | Number of Participants With Adverse Events | Any SAE : Severe | 0 participants |
| 12 to 24+ Months | Number of Participants With Adverse Events | Any AE : Severe | 0 participants |
| 12 to 24+ Months | Number of Participants With Adverse Events | Any AE : Moderate | 10 participants |
| 12 to 24+ Months | Number of Participants With Adverse Events | Any AE : Procedure Related | 18 participants |
| 12 to 24+ Months | Number of Participants With Adverse Events | Any SAE : Procedure Related | 2 participants |
| 12 to 24+ Months | Number of Participants With Adverse Events | Any SAE : Moderate | 2 participants |
| 12 to 24+ Months | Number of Participants With Adverse Events | Any AE | 36 participants |
| Overall | Number of Participants With Adverse Events | Any SAE | 17 participants |
| Overall | Number of Participants With Adverse Events | Any AE : Device Related | 26 participants |
| Overall | Number of Participants With Adverse Events | Any SAE : Mild | 5 participants |
| Overall | Number of Participants With Adverse Events | Any SAE : Severe | 6 participants |
| Overall | Number of Participants With Adverse Events | Any SAE : Procedure Related | 11 participants |
| Overall | Number of Participants With Adverse Events | Any SAE : Moderate | 7 participants |
| Overall | Number of Participants With Adverse Events | Any AE : Severe | 7 participants |
| Overall | Number of Participants With Adverse Events | Any AE : Moderate | 31 participants |
| Overall | Number of Participants With Adverse Events | Any SAE : Device Related | 5 participants |
| Overall | Number of Participants With Adverse Events | Any AE : Mild | 79 participants |
| Overall | Number of Participants With Adverse Events | Any AE : Procedure Related | 67 participants |
| Overall | Number of Participants With Adverse Events | Any AE | 98 participants |
Secondary
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months
Evaluation of the improvement of the Back VAS and Hip/Leg VAS (assessed together) 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 - 100mm with the 100mm accounting for the highest level of pain.
Time frame: Baseline (up to 90 days before surgery), 24 months
Population: 13 out of the 99 participants who returned at 24 months, did not complete the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months | -16.9 score on a scale | Standard Deviation 29.5 |
| Post-Operative to 3 Months | Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months | -0.2 score on a scale | Standard Deviation 13.2 |
| 3 to 6 Months | Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 24 Months | -2 score on a scale | Standard Deviation 17.8 |
Secondary
Change From Baseline in Quality of Life Scores on the SRS-22r at 24 Months
The Revised Scoliosis Research Society-22 (SRS-22r) is a specific questionnaire for spine conditions. It is applied to patients with idiopathic scoliosis, whose conditions and treatments have a great impact on their quality of life. The SRS 22r was created and revised with the purpose of evaluating this impact from the patient's point of view. The reviewed version contains 22 questions distributed into five domains: function/activity (FA), pain (P), self- image/appearance (SA), mental health (MH) and satisfaction with treatment (ST). The scores vary from 1 to 5 in which 5 is the best health quality of life of patients.
Time frame: Baseline (up to 90 days before surgery), 24 months
Population: While 99 participants completed 24 month interval, 14 patients out of the 99 did not did not complete the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Change From Baseline in Quality of Life Scores on the SRS-22r at 24 Months | 0.6 score on a scale | Standard Deviation 0.7 |
Secondary
Change in Percentage of Participants Able to Return to Work/School
The ability to and the time it takes for the subject to be cleared to return to work/school from the date of surgery by looking at the change in percentage of participants who were able to return to work without any restrictions
Time frame: Pre-Op to 24 months
Population: Includes all participants who returned for each visit interval with those who did not respond to this question accounted for in the missing row.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Patients | Change in Percentage of Participants Able to Return to Work/School | Unable to go due to back/leg pain/conditions | 0 Participants |
| All Patients | Change in Percentage of Participants Able to Return to Work/School | Attending work/school with some restrictions | 5 Participants |
| All Patients | Change in Percentage of Participants Able to Return to Work/School | Attending work/school with no restrictions | 172 Participants |
| All Patients | Change in Percentage of Participants Able to Return to Work/School | Unemployed, unrelated to back/leg conditions | 0 Participants |
| All Patients | Change in Percentage of Participants Able to Return to Work/School | Not attending work/school by choice | 11 Participants |
| All Patients | Change in Percentage of Participants Able to Return to Work/School | Missing | 0 Participants |
| Post-Operative to 3 Months | Change in Percentage of Participants Able to Return to Work/School | Not attending work/school by choice | 22 Participants |
| Post-Operative to 3 Months | Change in Percentage of Participants Able to Return to Work/School | Unable to go due to back/leg pain/conditions | 57 Participants |
| Post-Operative to 3 Months | Change in Percentage of Participants Able to Return to Work/School | Attending work/school with no restrictions | 19 Participants |
| Post-Operative to 3 Months | Change in Percentage of Participants Able to Return to Work/School | Unemployed, unrelated to back/leg conditions | 0 Participants |
| Post-Operative to 3 Months | Change in Percentage of Participants Able to Return to Work/School | Missing | 0 Participants |
| Post-Operative to 3 Months | Change in Percentage of Participants Able to Return to Work/School | Attending work/school with some restrictions | 83 Participants |
| 3 to 6 Months | Change in Percentage of Participants Able to Return to Work/School | Attending work/school with no restrictions | 44 Participants |
| 3 to 6 Months | Change in Percentage of Participants Able to Return to Work/School | Missing | 1 Participants |
| 3 to 6 Months | Change in Percentage of Participants Able to Return to Work/School | Not attending work/school by choice | 7 Participants |
| 3 to 6 Months | Change in Percentage of Participants Able to Return to Work/School | Unable to go due to back/leg pain/conditions | 4 Participants |
| 3 to 6 Months | Change in Percentage of Participants Able to Return to Work/School | Unemployed, unrelated to back/leg conditions | 0 Participants |
| 3 to 6 Months | Change in Percentage of Participants Able to Return to Work/School | Attending work/school with some restrictions | 104 Participants |
| 6 to 12 Months | Change in Percentage of Participants Able to Return to Work/School | Unable to go due to back/leg pain/conditions | 0 Participants |
| 6 to 12 Months | Change in Percentage of Participants Able to Return to Work/School | Not attending work/school by choice | 2 Participants |
| 6 to 12 Months | Change in Percentage of Participants Able to Return to Work/School | Missing | 0 Participants |
| 6 to 12 Months | Change in Percentage of Participants Able to Return to Work/School | Attending work/school with some restrictions | 44 Participants |
| 6 to 12 Months | Change in Percentage of Participants Able to Return to Work/School | Unemployed, unrelated to back/leg conditions | 0 Participants |
| 6 to 12 Months | Change in Percentage of Participants Able to Return to Work/School | Attending work/school with no restrictions | 101 Participants |
| 12 to 24+ Months | Change in Percentage of Participants Able to Return to Work/School | Attending work/school with some restrictions | 14 Participants |
| 12 to 24+ Months | Change in Percentage of Participants Able to Return to Work/School | Attending work/school with no restrictions | 117 Participants |
| 12 to 24+ Months | Change in Percentage of Participants Able to Return to Work/School | Missing | 1 Participants |
| 12 to 24+ Months | Change in Percentage of Participants Able to Return to Work/School | Not attending work/school by choice | 3 Participants |
| 12 to 24+ Months | Change in Percentage of Participants Able to Return to Work/School | Unable to go due to back/leg pain/conditions | 0 Participants |
| 12 to 24+ Months | Change in Percentage of Participants Able to Return to Work/School | Unemployed, unrelated to back/leg conditions | 0 Participants |
| Overall | Change in Percentage of Participants Able to Return to Work/School | Missing | 2 Participants |
| Overall | Change in Percentage of Participants Able to Return to Work/School | Unemployed, unrelated to back/leg conditions | 0 Participants |
| Overall | Change in Percentage of Participants Able to Return to Work/School | Not attending work/school by choice | 0 Participants |
| Overall | Change in Percentage of Participants Able to Return to Work/School | Attending work/school with no restrictions | 93 Participants |
| Overall | Change in Percentage of Participants Able to Return to Work/School | Attending work/school with some restrictions | 4 Participants |
| Overall | Change in Percentage of Participants Able to Return to Work/School | Unable to go due to back/leg pain/conditions | 0 Participants |
Secondary
Estimated Blood Loss
The amount of blood loss over the entire length of the surgery was captured.
Time frame: During surgery
Population: 187 patients had blood loss included. There were 3 additional procedures staged increasing the overall number of units analyzed to 190.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Estimated Blood Loss | 672.34 Cubic Centimeters | Standard Deviation 588.14 |
Secondary
Investigator's Rating of Subject's Clinical Disposition Using 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 worsened.
Time frame: 24 months
Population: Patients who were rated based on the outcome of their treatment and would indicate either Excellent, Good or Fair/Satisfactory. No responses are shown under missing
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Patients | Investigator's Rating of Subject's Clinical Disposition Using Odom's Criteria | Fair/Satisfactory | 2 Participants |
| All Patients | Investigator's Rating of Subject's Clinical Disposition Using Odom's Criteria | Good | 15 Participants |
| All Patients | Investigator's Rating of Subject's Clinical Disposition Using Odom's Criteria | Excellent | 78 Participants |
| All Patients | Investigator's Rating of Subject's Clinical Disposition Using Odom's Criteria | Missing | 4 Participants |
Secondary
Length of Anesthesia Time
The length of time the patient is under anesthesia was captured.
Time frame: During surgery
Population: 183 subjects had anesthesia time included. There were 3 staged procedures increasing the overall number of units analyzed to 186.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Length of Anesthesia Time | 373.67 Minutes | Standard Deviation 91.97 |
Secondary
Length of Hospital Stay
The length of the hospital stay from the date of admission to the date of discharge.
Time frame: Admission to Discharge
Population: 186 patients completed admit and discharge dates
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Length of Hospital Stay | 5.28 Days | Standard Deviation 1.79 |
Secondary
Length of Surgery Time
The length of the surgical procedure from the initial incision to final closure were captured.
Time frame: During surgery
Population: 186 patients had their surgery times recorded. There were 3 additional procedures staged increasing the overall number of units analyzed to 189.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Length of Surgery Time | 267.01 Minutes | Standard Deviation 79.89 |
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 months and 24 months
Population: Patient self-assessment of the procedure at 12M and 24M
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Patients | Patient Satisfaction | Repeat Procedure | Not Reported | 7 Participants |
| All Patients | Patient Satisfaction | Satisfied | No | 4 Participants |
| All Patients | Patient Satisfaction | Repeat Procedure | No | 23 Participants |
| All Patients | Patient Satisfaction | Satisfied | Not Reported | 7 Participants |
| All Patients | Patient Satisfaction | Satisfied | Yes | 124 Participants |
| All Patients | Patient Satisfaction | Repeat Procedure | Yes | 105 Participants |
| Post-Operative to 3 Months | Patient Satisfaction | Satisfied | Yes | 86 Participants |
| Post-Operative to 3 Months | Patient Satisfaction | Repeat Procedure | No | 12 Participants |
| Post-Operative to 3 Months | Patient Satisfaction | Repeat Procedure | Not Reported | 11 Participants |
| Post-Operative to 3 Months | Patient Satisfaction | Repeat Procedure | Yes | 76 Participants |
| Post-Operative to 3 Months | Patient Satisfaction | Satisfied | No | 2 Participants |
| Post-Operative to 3 Months | Patient Satisfaction | Satisfied | Not Reported | 11 Participants |
Secondary
Use of Narcotics Post-surgery
The types and dosages of any narcotics taken by the patient pre- and post-surgery was documented.
Time frame: Pre-Op to 24 months
Population: Includes all participants who returned for each visit interval with those who did not respond to this question accounted for in the missing row.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| All Patients | Use of Narcotics Post-surgery | Back Meds | Chronic daily long-acting narcotics | 0 Participants |
| All Patients | Use of Narcotics Post-surgery | Non-Back Meds | Chronic daily short-acting narcotics | 0 Participants |
| All Patients | Use of Narcotics Post-surgery | Back Meds | Non-narcotics or NSAIDS | 53 Participants |
| All Patients | Use of Narcotics Post-surgery | Back Meds | Epidural/Facet injection | 0 Participants |
| All Patients | Use of Narcotics Post-surgery | Non-Back Meds | Missing | 0 Participants |
| All Patients | Use of Narcotics Post-surgery | Back Meds | IV or injected narcotics | 0 Participants |
| All Patients | Use of Narcotics Post-surgery | Back Meds | Chronic daily short-acting narcotics | 1 Participants |
| All Patients | Use of Narcotics Post-surgery | Non-Back Meds | Intermittent short-acting narcotics | 0 Participants |
| All Patients | Use of Narcotics Post-surgery | Non-Back Meds | None | 157 Participants |
| All Patients | Use of Narcotics Post-surgery | Non-Back Meds | Epidural/Facet injection | 0 Participants |
| All Patients | Use of Narcotics Post-surgery | Back Meds | None | 128 Participants |
| All Patients | Use of Narcotics Post-surgery | Non-Back Meds | IV or injected narcotics | 0 Participants |
| All Patients | Use of Narcotics Post-surgery | Non-Back Meds | Chronic daily long-acting narcotics | 0 Participants |
| All Patients | Use of Narcotics Post-surgery | Back Meds | Missing | 0 Participants |
| All Patients | Use of Narcotics Post-surgery | Non-Back Meds | Non-narcotics or NSAIDS | 31 Participants |
| All Patients | Use of Narcotics Post-surgery | Back Meds | Intermittent short-acting narcotics | 6 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Non-Back Meds | Missing | 0 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Non-Back Meds | Intermittent short-acting narcotics | 7 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Back Meds | Chronic daily short-acting narcotics | 18 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Non-Back Meds | IV or injected narcotics | 0 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Non-Back Meds | Chronic daily short-acting narcotics | 1 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Back Meds | None | 46 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Back Meds | Chronic daily long-acting narcotics | 6 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Back Meds | IV or injected narcotics | 6 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Back Meds | Epidural/Facet injection | 0 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Non-Back Meds | Chronic daily long-acting narcotics | 0 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Back Meds | Intermittent short-acting narcotics | 77 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Back Meds | Non-narcotics or NSAIDS | 28 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Non-Back Meds | Epidural/Facet injection | 0 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Back Meds | Missing | 0 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Non-Back Meds | None | 151 Participants |
| Post-Operative to 3 Months | Use of Narcotics Post-surgery | Non-Back Meds | Non-narcotics or NSAIDS | 22 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Back Meds | Missing | 1 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Back Meds | Non-narcotics or NSAIDS | 29 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Back Meds | Chronic daily short-acting narcotics | 2 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Non-Back Meds | Chronic daily long-acting narcotics | 0 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Non-Back Meds | Chronic daily short-acting narcotics | 0 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Non-Back Meds | Intermittent short-acting narcotics | 0 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Non-Back Meds | None | 141 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Back Meds | Intermittent short-acting narcotics | 9 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Back Meds | IV or injected narcotics | 0 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Back Meds | None | 118 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Non-Back Meds | Non-narcotics or NSAIDS | 18 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Non-Back Meds | Missing | 1 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Back Meds | Epidural/Facet injection | 0 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Non-Back Meds | Epidural/Facet injection | 0 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Back Meds | Chronic daily long-acting narcotics | 1 Participants |
| 3 to 6 Months | Use of Narcotics Post-surgery | Non-Back Meds | IV or injected narcotics | 0 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Non-Back Meds | Epidural/Facet injection | 0 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Non-Back Meds | Chronic daily long-acting narcotics | 0 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Non-Back Meds | Intermittent short-acting narcotics | 0 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Back Meds | Non-narcotics or NSAIDS | 28 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Back Meds | Intermittent short-acting narcotics | 5 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Back Meds | IV or injected narcotics | 0 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Back Meds | Chronic daily short-acting narcotics | 0 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Non-Back Meds | Non-narcotics or NSAIDS | 22 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Back Meds | Missing | 0 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Non-Back Meds | Chronic daily short-acting narcotics | 0 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Non-Back Meds | None | 125 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Back Meds | Chronic daily long-acting narcotics | 0 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Non-Back Meds | Missing | 0 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Back Meds | Epidural/Facet injection | 0 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Back Meds | None | 114 Participants |
| 6 to 12 Months | Use of Narcotics Post-surgery | Non-Back Meds | IV or injected narcotics | 0 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Back Meds | IV or injected narcotics | 0 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Back Meds | Intermittent short-acting narcotics | 1 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Back Meds | Chronic daily short-acting narcotics | 0 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Back Meds | Chronic daily long-acting narcotics | 0 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Back Meds | Epidural/Facet injection | 0 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Non-Back Meds | Chronic daily long-acting narcotics | 0 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Back Meds | None | 112 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Back Meds | Non-narcotics or NSAIDS | 22 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Back Meds | Missing | 0 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Non-Back Meds | None | 118 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Non-Back Meds | Non-narcotics or NSAIDS | 17 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Non-Back Meds | Intermittent short-acting narcotics | 0 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Non-Back Meds | Chronic daily short-acting narcotics | 0 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Non-Back Meds | IV or injected narcotics | 0 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Non-Back Meds | Epidural/Facet injection | 0 Participants |
| 12 to 24+ Months | Use of Narcotics Post-surgery | Non-Back Meds | Missing | 0 Participants |
| Overall | Use of Narcotics Post-surgery | Non-Back Meds | Non-narcotics or NSAIDS | 13 Participants |
| Overall | Use of Narcotics Post-surgery | Non-Back Meds | None | 84 Participants |
| Overall | Use of Narcotics Post-surgery | Back Meds | Intermittent short-acting narcotics | 1 Participants |
| Overall | Use of Narcotics Post-surgery | Non-Back Meds | IV or injected narcotics | 0 Participants |
| Overall | Use of Narcotics Post-surgery | Back Meds | Missing | 4 Participants |
| Overall | Use of Narcotics Post-surgery | Back Meds | Non-narcotics or NSAIDS | 16 Participants |
| Overall | Use of Narcotics Post-surgery | Back Meds | None | 78 Participants |
| Overall | Use of Narcotics Post-surgery | Back Meds | Epidural/Facet injection | 0 Participants |
| Overall | Use of Narcotics Post-surgery | Non-Back Meds | Missing | 2 Participants |
| Overall | Use of Narcotics Post-surgery | Non-Back Meds | Epidural/Facet injection | 0 Participants |
| Overall | Use of Narcotics Post-surgery | Back Meds | IV or injected narcotics | 0 Participants |
| Overall | Use of Narcotics Post-surgery | Back Meds | Chronic daily long-acting narcotics | 0 Participants |
| Overall | Use of Narcotics Post-surgery | Back Meds | Chronic daily short-acting narcotics | 0 Participants |
| Overall | Use of Narcotics Post-surgery | Non-Back Meds | Chronic daily long-acting narcotics | 0 Participants |
| Overall | Use of Narcotics Post-surgery | Non-Back Meds | Chronic daily short-acting narcotics | 0 Participants |
| Overall | Use of Narcotics Post-surgery | Non-Back Meds | Intermittent short-acting narcotics | 0 Participants |