AccuLIF® PROSPECTIVE PATIENT OUTCOMES STUDY

Conditions

Degenerative Disc Disease, Retrolisthesis, Spondylolisthesis, Grade 1

Brief summary

This is a post-market clinical study of the AccuLIF expandable transforaminal lumbar interbody fusion (TLIF) cage in patients requiring surgery for degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis, at one or two levels, between L2 and S1.

Detailed description

Study evaluations will be evaluated pre-operatively and at 6-weeks, 3-months, 6-months, 12-months and 24-months post-operatively to assess clinical outcomes, patient reported outcomes and radiographic status.

Related papers

No related papers found yet.

Interventions

DEVICEAccuLIF expandable TLIF cage

AccuLIF TL expandable interbody cage used with autogenous bone and/or allograft (cancellous or corticocancellous allograft chips) and supplemental fixation.

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

No

Inclusion criteria

1. Subject is skeletally mature and between 18 and 70 years of age. 2. DDD and up to Grade I spondylolisthesis or retrolisthesis, requiring decompression and arthrodesis at one or two contiguous levels between L2 and S1. 3. No previous surgery at the same or adjacent level (other than microdiscectomy / laminectomy) at the same or adjacent level. 4. Non-responsive to conservative (non-surgical) treatment for back pain for a minimum of 6 months. 5. Subject understands the conditions of enrollment and is willing to sign and date the Informed Consent. 6. Subject agrees to comply with visit schedule and completing study questionnaires.

Exclusion criteria

1. Significant instability of the spine. 2. Requires TLIF at more than 2 levels between L2 and S1. 3. Previously undergone lumbar spine surgery (other than microdiscectomy / laminectomy) at the same or adjacent level. 4. Younger than 18 years of age, or older than 70 years of age. 5. BMI of 40 or greater. 6. History of metabolic bone disease 7. Osteoporosis 8. Diabetes mellitus requiring daily insulin management. 9. Subject has any of the following: 1. Progressive neuromuscular disease; OR 2. Autoimmune disease; OR 3. Active malignancy within the last 15 years; OR 4. Active hepatitis; OR 5. AIDS, ARC, or is HIV positive; OR 6. Syringomyelia at any spinal level; OR 7. Any other condition that would interfere with the subject self -assessment of pain, function or quality of life. 10. Allergy to implant materials (titanium, titanium alloy). 11. Active systemic infection or infection localized to the site of implantation. 12. Primary or metastatic tumors involving the spine. 13. Open wounds or inadequate issue tissue coverage over the operative site. 14. History of significant mental illness or mental incapacity. 15. Pregnancy or intent to become pregnant. 16. Participating in another investigational study for a similar purpose. 17. Belongs to a vulnerable population that would compromise ability to provide informed consent or compliance with follow-up requirements. 18. Smokers unwilling to cease up to 3 months post-op or recent history of alcohol or other substance abuse within the past 2 years. 19. Workers compensation.

Design outcomes

Primary

Measure	Time frame	Description
Post-operative Radiographic Measurements to Evaluate Segmental Lordosis as Measured by Degree of Change From Pre-operative X-rays.	24 months	Post-operative radiographic measurements to evaluate segmental lordosis as measured by degree of change from pre-operative x-rays.
Pre-operative Comparison to Post-operative Radiographic Outcomes of Disc Height as Measured in mm.	24 months	Pre-operative comparison to post-operative radiographic outcomes of disc height as measured in mm.

Secondary

Measure	Time frame	Description
Surgical Outcomes: To Measure the Amount of Blood Loss at the Time of Surgery.	Operative Visit	Surgical Outcomes: To measure the amount of blood loss at the time of surgery.
Medical Outcomes: Incidence of Complications Associated With the Procedure and/or Device.	24 months	Medical Outcomes: Incidence of complications associated with the procedure and/or device.
Medical Outcomes: Comparison of Pre-operative Neurological Reflex Evaluations in the Lower Extremities to Post-operative Findings	24 months	Medical Outcomes: Comparison of pre-operative neurological Reflex evaluations in the lower extremities to post-operative findings
Medical Outcomes: Comparison of Pre-operative Neurological Sensory Responses in the Lower Extremities to Post-operative Findings.	24 months	Medical Outcomes: Comparison of pre-operative neurological Sensory Responses in the lower extremities to post-operative findings.
Medical Outcomes: Comparison of Pre-operative Neurological Motors Assessments Evaluated by Straight Leg Raise, Femoral Stretch, and Strength Assessments, to Post-operative Findings.	24 months	Medical Outcomes: Comparison of pre-operative neurological Motors assessments evaluated by Straight Leg Raise, Femoral Stretch, and Strength assessments, to post-operative findings.
Surgical Outcomes: To Measure the Length of Surgery as Measured in Time of Surgery Duration.	Operative Visit	Surgical Outcomes: To measure the length of surgery as measured in time of surgery duration.
Patient Reported Outcomes: Oswestry Disability Index Measurements for Comparison of Pre-operative to Post-operative Evaluations.	24 months	Patient Reported Outcomes: Oswestry Disability Index measurements for comparison of pre-operative to post-operative evaluations.
Patient Reported Outcomes: Evaluations of Quality of Life (QOL) as Measured by the SF-12.	24 months	Patient Reported Outcomes: Evaluations of Quality of Life (QOL) as measured by the SF-12.
Radiographic Outcomes: Fusion Status Evaluated by X-ray and/or CT Assessments.	24 months	Radiographic Outcomes: Fusion status evaluated by x-ray and/or CT assessments.
Radiographic Outcomes: Device Placement Status as Evaluated by X-ray and/or CT Imaging.	24 months	Radiographic Outcomes: Device placement status as evaluated by x-ray and/or CT imaging.
Patient Reported Outcomes: Comparison of Pre-operative Back Pain Scores to Post-operative Levels as Measured by the (Visual Analog Scale (VAS).	24 months	Patient Reported Outcomes: Comparison of pre-operative back pain scores to post-operative levels as measured by the (Visual Analog Scale (VAS).
Surgical Outcomes: To Evaluate the Length of Time Hospitalized for the Index Procedure as Measured in Days.	Peri-op	Surgical Outcomes: To evaluate the length of time hospitalized for the index procedure as measured in days.

Countries

United States

Participant flow

Participants by arm

Arm	Count
AccuLIF TL All subjects enrolled were assigned to receive lumbar interbody fusion via a TLIF approach with the AccuLIF TL cage.	9
Total	9

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Physician Decision	1
Overall Study	Study device not implanted	2

Baseline characteristics

Characteristic	AccuLIF TL
Age, Continuous	55 years STANDARD_DEVIATION 12.1
BMI	32 kg/m2 STANDARD_DEVIATION 5.4
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	1 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	8 Participants
Sex: Female, Male Female	3 Participants
Sex: Female, Male Male	6 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 9
other Total, other adverse events	2 / 9
serious Total, serious adverse events	2 / 9

Outcome results

Primary

Post-operative Radiographic Measurements to Evaluate Segmental Lordosis as Measured by Degree of Change From Pre-operative X-rays.

Post-operative radiographic measurements to evaluate segmental lordosis as measured by degree of change from pre-operative x-rays.

Time frame: 24 months

Population: The Primary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Primary Outcome Measure.

Primary

Pre-operative Comparison to Post-operative Radiographic Outcomes of Disc Height as Measured in mm.

Pre-operative comparison to post-operative radiographic outcomes of disc height as measured in mm.

Time frame: 24 months

Population: The Primary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Primary Outcome Measure.

Secondary

Medical Outcomes: Comparison of Pre-operative Neurological Motors Assessments Evaluated by Straight Leg Raise, Femoral Stretch, and Strength Assessments, to Post-operative Findings.

Medical Outcomes: Comparison of pre-operative neurological Motors assessments evaluated by Straight Leg Raise, Femoral Stretch, and Strength assessments, to post-operative findings.

Time frame: 24 months