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

Paradigm Spine

Status

Completed

Conditions

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

Treatments

Procedure: Decompression

Study type

Interventional

Funder types

Industry

Identifiers

NCT01727752

NTR1307

Details and patient eligibility

About

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

Full 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.

Enrollment

386 patients

Sex

All

Ages

40 to 85 years old

Volunteers

No Healthy Volunteers

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