A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

386 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2015-06-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Intermittent Neurogenic Claudication (INC) as a Result of Spinal Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgical decompression

Group Type ACTIVE_COMPARATOR

Decompression

Intervention Type PROCEDURE

coflex Interlaminar Technology

Surgical decompression followed by implantation of coflex Interlaminar Technology.

Group Type ACTIVE_COMPARATOR

Decompression

Intervention Type PROCEDURE

Interventions

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Decompression

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No