Clinical trial NCT01727752: A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis
Official title: A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intermittent Neurogenic Claudication (INC) as a Result of Spinal Stenosis
Lead sponsor: Paradigm Spine
Sponsor class: INDUSTRY
First posted: 2012-11-16
Enrollment: 386
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Randomized, Blinded Comparison of Surgical Intervention with the Coflex® Interspinous Implant versus Surgical Decompression for Patients with Intermittent Neurogenic Claudication caused by Lumbar Stenosis

Detailed description: In this investigation, it will be investigated whether the effectiveness of surgical intervention with Coflex® is equivalent to surgical decompression after 12 months in people with intermittent claudication. The main advantage of coflex® might be a faster recovery after surgery, but after long term follow-up it is unknown if this treatment effect remains. Therefore in addition, it will be investigated whether surgical intervention with coflex® is more effective than surgical decompression on short-term follow-up (8 weeks to 6 months) and whether surgical intervention with coflex® is more cost-effective after 12 months than surgical decompression.

Eligibility criteria: Inclusion Criteria:

* signed informed consent
* is 40 to 85 years old at time of surgery
* has INC, as noted by leg/buttock/groin pain with or without back pain. Leg/buttock/groin pain needs to be strongly relieved when flexed such as when sitting in a chair
* has received at least three months of conservative care therapy which may have included, but is not limited to, physical therapy, bracing, systemic and/or injected medications
* has a regular indication for surgical intervention of INC
* has a narrowed lumbar spinal canal, nerve root canal or intervertebral foramen at one or two levels confirmed by MRI
* is physically and mentally willing and able to comply with, or has a caregiver who is willing and able to comply with, the post-operative evaluations.

Exclusion Criteria:

* has cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder dysfunction (bladder retention or incontinence)
* has Paget's disease, severe osteoporosis or metastasis to the vertebrae
* has significant scoliosis (Cobb angle \> 25 degrees)
* has a Body Mass Index (BMI) \> 40 kg/m2
* has had any surgery of the lumbar spine
* has degenerative spondylolisthesis \> grade 1 (on a scale 1 to 4) at the affected level
* has significant instability of the lumbar spine
* has severe comorbid conditions that will increase the risk to the patient or interfere with the evaluability of this study
* has a fused segment at the indicated level.
* has a herniated disk on the level of interest

Primary outcomes:
measure: Zurich Claudication Questionnaire (ZCQ)
timeFrame: 5 years
Secondary outcomes:
measure: EuroQOL (EQ-5D)
timeFrame: 5 years
measure: MRDQ
timeFrame: 5 years
measure: SF-36
timeFrame: 5 years
measure: McGill Pain Questionnaire
timeFrame: 5 years
measure: VAS Leg Pain
timeFrame: 5 years
measure: Re-operations, revisions, and major complications
timeFrame: 5 years
measure: Radiographic Assessment
timeFrame: 12 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Sint Lucas Andreas Ziekenhuis
city: Delft
country: Netherlands
facility: Reinier De Graaf Gasthuis
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis
city: Holland
country: Netherlands
facility: Medical Center Alkmaar
city: Leiden
country: Netherlands
facility: Diaconessenhuis
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Leiderdorp
country: Netherlands
facility: Rijnland ziekenhuis,
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Ziekenhuis
city: Schiedam
country: Netherlands
facility: Vlietland Ziekenhuis
city: The Hague/Leidschendam
country: Netherlands
facility: Medical Center Haaglanden
city: The Hague
country: Netherlands
facility: Bronovo Ziekenhuis
city: The Hague
country: Netherlands
facility: HAGA ziekenhuis
city: Zwolle
country: Netherlands
facility: Isala Klinieken
Study officials:
References: