Comparative Evaluation of Clinical Outcome in the Treatment of Degenerative Spinal Stenosis With Concomitant Low Back Pain by Decompression With and Without Additional Stabilization Using the Coflex™ Interlaminar Technology
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Stenosis
- Sponsor
- Paradigm Spine
- Enrollment
- 246
- Locations
- 8
- Primary Endpoint
- Change in ODI From Baseline to 24 Months
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
A 2 year comparative evaluation of clinical outcome in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with and without additional stabilization using the coflex® Interlaminar Technology
Detailed Description
The coflex® implant for interlaminar stabilization has been in clinical use for more than 10 years and is CE-certified according to the standards and approved in the United States. This was a randomized multicenter study to collect prospective data for potential improvement in the therapy of low back pain during the treatment of spinal stenosis. The study was conducted in Germany.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Radiographic confirmation of clinical symptoms of at least moderate degenerative spinal stenosis, with constriction of the central spinal canal of one or two adjacent segments in the region L3 to L5 with the need for decompression.
- •If necessary additional decompression in the adjacent segment(s) may be performed avoiding any instability in the affected segment.
- •In addition the following may exist (but is not obligatory):
- •hypertrophy of the facet joints and subarticular recessus stenosis in the relevant segment or
- •stenosis of the foramen in the relevant segment
- •and/or stable retrolisthesis up to grade I verified by flexion-/extension X-ray films.
- •Radiographic confirmation of no translatory instability in the main segment as well as in adjacent segments (dynamic translatory instability ≤ 3 mm).
- •VAS back pain score of at least 50 mm on a 100 mm scale (for acute back pain or a period of at least 3 month of back pain before the onset of leg pain).
- •Minimum of 3 months conservative therapy without improvement of symptoms.
- •Age \>40 years.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in ODI From Baseline to 24 Months
Time Frame: Baseline, 3, 12, and 24 months
The ODI, also known as the Oswestry Low Back Pain Disability Questionnaire is a questionnaire providing information on back and leg pain and the affects on managing everyday life by dividing questions into 10 sections. For this study, the questions on sexual activity will not be asked. The total possible score for each section is 0-5. The scores are then converted percentages ranging from 0% (minimal disability) to 100% (maximum possible disability).
Secondary Outcomes
- Number of Participants With Adverse Events - Operative Site(2 years)
- Neurological Status - Mean Change in Muscle Strength From Baseline to 24 Months(Baseline, Day 0 (Surgery), 3, 12, and 24 months)
- Neurological Status- Mean Change in Ilio Sacral Joint Affection Test From Baseline to 24 Months.(Baseline, Day 0 (Surgery), 3, 12, and 24 months)
- Change in Visual Analog Scale (VAS) Leg Pain From Baseline to 24 Months(Baseline, 3, 12, and 24 months)
- Neurological Status - Mean Change in Sensory Deficit From Baseline to 24 Months(Baseline, 3, 12, and 24 months)
- Number of Participants With Significant Migration or Expulsion of the Implant(2 years)
- Change in Visual Analog Scale (VAS) Back Pain From Baseline to 24 Months(Baseline, 3, 12, and 24 months)
- The Percentage of Patients With Survival Probability as Assessed by Evaluating Treatment Failure in Both Groups..(2 years)
- Change of Symptoms- Zurich Claudication Questionnaire (ZCQ) After 24 Months Compared to Baseline.(Baseline, 3, 12, and 24 months)
- Number of Participants Receiving Epidural Injections(2 years)
- Neurological Status- Mean Change in Trendelenburg Sign Test From Baseline to 24 Months.(Baseline, Day 0 (Surgery), 3, 12, and 24 months)
- Change in Functionality- Zurich Claudication Questionnaire (ZCQ) From Baseline to 24 Months(Baseline, 3, 12, and 24 months)
- Assessment of Time to Symptoms Utilizing Walking Distance Test(2 years)
- Assessment of Neurological Status Using the Laségue Test or Straight Leg Raise Test- Change From Baseline to 24 Months(Baseline, Day 0 (Surgery), 3, 12, and 24 months)