Clinical trial NCT01316211: Clinical Trial Comparing Decompression With and Without Coflex™ Interlaminar Technology Treating Lumbar Spinal Stenosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Stenosis
Keywords: Back Pains
Pain, Back
Pains, Back
Backache
Backaches
Back Ache
Ache, Back
Aches, Back
Back Aches
Back Pain without Radiation
Vertebrogenic Pain Syndrome
Pain Syndrome, Vertebrogenic
Pain Syndromes, Vertebrogenic
Syndrome, Vertebrogenic Pain
Syndromes, Vertebrogenic Pain
Vertebrogenic Pain Syndromes
Back Pain with Radiation
Stenosis, spinal
Caudal stenosis
Spondylopathy
Spondylopathies
Low back pain
Lower back pain
Lead sponsor: Paradigm Spine
Sponsor class: INDUSTRY
Collaborators: name: MDT Medical Device Testing GmbH
name: MCRA
First posted: 2011-03-16
Enrollment: 246
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Radiographic confirmation of no translatory instability in the main segment as well as in adjacent segments (dynamic translatory instability ≤ 3 mm).
3. 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).
4. Minimum of 3 months conservative therapy without improvement of symptoms.
5. Age \>40 years.
6. Oswestry Low Back Pain Disability Questionnaire score of at least 18/45 (40%) for German sites or 20/50 (40%) for the US sites (The question about sexual life will be excluded).
7. Suitability of the patient for a posterior surgery procedure.
8. Mental and physical ability of patient to follow the protocol according to compliance to time schedule, treatment plan, fill in of CRF pages and further study procedures.
9. Personally signed informed consent form before the start of any study related procedures.

Exclusion Criteria

Any of the following will exclude a subject from the study:

1. Preceding fusion or decompression surgery of the lumbar spine or preceding nucleotomy of the segments of concern (also if nucleotomy becomes necessary during surgery).
2. Radiographically confirmed damage of the vertebral body in the segment of concern in the lumbar spine (e.g. osteoporotic compression fracture or because of tumors)
3. Isthmic and degenerative spondylolisthesis (anterolisthesis; retrolisthesis \> grade I) or spondylolysis (Pars fracture).
4. Degenerative lumbar scoliosis (\> 25°).
5. Adipositas (obesity). Defined as a body mass index \>40.
6. Pregnancy, or wish to get pregnant during the course of the study.
7. Known allergy for titanium and titanium alloys.
8. Fluoride infections - both systemic and local.
9. History of severe peripheral neuropathy.
10. Significant peripheral vascular disease (claudication intermittens ≥ stage 2b).
11. M. Paget or osteomalacia or other metabolic bone disorders.
12. Cauda equina syndrome.
13. Communicating diseases, including HIV, active hepatitis
14. Patients who are lawfully kept in an institution.
15. Subjects who, in the opinion of the investigator, will be inappropriate for inclusion into this clinical trial or will not comply with requirements of the study.
16. Subjects who participated in a clinical observation or therapy with X-ray during the last 10 years.
17. Subjects who participate(d) in another clinical trial (within the last 4 weeks) that might influence the safety and effectiveness assessment of this trial.

Primary outcomes:
measure: Change in ODI From Baseline to 24 Months
timeFrame: Baseline, 3, 12, and 24 months
Secondary outcomes:
measure: Number of Participants With Significant Migration or Expulsion of the Implant
timeFrame: 2 years
measure: Change in Visual Analog Scale (VAS) Back Pain From Baseline to 24 Months
timeFrame: Baseline, 3, 12, and 24 months
measure: Change in Visual Analog Scale (VAS) Leg Pain From Baseline to 24 Months
timeFrame: Baseline, 3, 12, and 24 months
measure: Neurological Status - Mean Change in Sensory Deficit From Baseline to 24 Months
timeFrame: Baseline, 3, 12, and 24 months
measure: Assessment of Time to Symptoms Utilizing Walking Distance Test
timeFrame: 2 years
measure: Number of Participants With Adverse Events - Operative Site
timeFrame: 2 years
measure: The Percentage of Patients With Survival Probability as Assessed by Evaluating Treatment Failure in Both Groups..
timeFrame: 2 years
measure: Change of Symptoms- Zurich Claudication Questionnaire (ZCQ) After 24 Months Compared to Baseline.
timeFrame: Baseline, 3, 12, and 24 months
measure: Change in Functionality- Zurich Claudication Questionnaire (ZCQ) From Baseline to 24 Months
timeFrame: Baseline, 3, 12, and 24 months
measure: Neurological Status - Mean Change in Muscle Strength From Baseline to 24 Months
timeFrame: Baseline, Day 0 (Surgery), 3, 12, and 24 months
measure: Assessment of Neurological Status Using the Laségue Test or Straight Leg Raise Test- Change From Baseline to 24 Months
timeFrame: Baseline, Day 0 (Surgery), 3, 12, and 24 months
measure: Number of Participants Receiving Epidural Injections
timeFrame: 2 years
measure: Neurological Status- Mean Change in Trendelenburg Sign Test From Baseline to 24 Months.
timeFrame: Baseline, Day 0 (Surgery), 3, 12, and 24 months
measure: Neurological Status- Mean Change in Ilio Sacral Joint Affection Test From Baseline to 24 Months.
timeFrame: Baseline, Day 0 (Surgery), 3, 12, and 24 months
Other outcomes:
Locations:
city: Potsdam
country: Germany
facility: Oberlinklinik Potsdam Orthopädische Fachklinik
state: Brandenburg
city: Frankfurt a.M.
country: Germany
facility: Orthopädische Universitätsklinik Frankfurt a.M.
state: Hesse
city: Rostock
country: Germany
facility: Chirurgische Universitätsklinik Rostock Neurochirurgie
state: Mecklenburg-Western Pomerania
city: Magdeburg
country: Germany
facility: Otto-von-Guericke-Universität Magdeburg Klinik für Orthopädie
state: Saxony-Anhalt
city: Damp
country: Germany
facility: Ostseeklinik Damp Neurochirurgie
state: Schleswig-Holstein
city: Lübeck
country: Germany
facility: Klinik für Neurochirurgie Lübeck
state: Schleswig-Holstein
city: Neustadt
country: Germany
facility: Klinik für Wirbelsäulenchirurgie mit Skoliosezentrum Klinikum Neustadt
state: Schleswig-Holstein
city: Ingolstadt
country: Germany
facility: Klinikum Ingolstadt Neurochirurgie
Study officials:
References:
citation: Schmidt S, Franke J, Rauschmann M, Adelt D, Bonsanto MM, Sola S. Prospective, randomized, multicenter study with 2-year follow-up to compare the performance of decompression with and without interlaminar stabilization. J Neurosurg Spine. 2018 Apr;28(4):406-415. doi: 10.3171/2017.11.SPINE17643. Epub 2018 Jan 26.