Effects of X-STOP® Versus Laminectomy Study

NCT00558129 | Withdrawn Phase 4

• 1 other identifier: LSS0702
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine if the effectiveness of the X-STOP® implant is equivalent (non-inferior) to that of conventional laminectomy in patients with lumbar spinal stenosis as measured by the Zurich Claudication Questionnaire.

Conditions

Lumbar Spinal Stenosis

Keywords

Lumbar Spinal Stenosis; X-STOP® IPD; Interspinous process decompression; Neurogenic Intermittent Claudication

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the Zurich Claudication Questionnaire (ZCQ)

  1 year post-operative

Secondary Outcomes (1)

• ZCQ symptom severity, physical function and satisfaction; pain rating; quality of life (SF-36®); operative data; canal, subarticular and neuroforaminal measurements on MRI; spinal stability using flexion/extension (serious adverse events)

  Out to 2 years postoperative

Study Arms (2)

Investigational

EXPERIMENTAL

X-STOP® PEEK IPD

Device: X-STOP®

Control

ACTIVE COMPARATOR

Laminectomy

Procedure: Laminectomy

Interventions

X-STOP® DEVICE

Surgical implantation of X-STOP IPD device

Also known as: X-STOP® PEEK IPD

Investigational

Laminectomy PROCEDURE

Standard laminectomy techniques will be used and may include laminotomy, foraminotomy and/or laminectomy as appropriate. In some cases at the discretion of the treating physician, fusion may indicated to stabilize the segment.

Control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 50
• Has completed at least 6 months of conservative therapy which may include but is not limited to epidural steroid injection, oral steroids, NSAIDS, analgesics, physical therapy, and/or spinal manipulation.
• Symptoms of leg/buttock/groin pain with or without back pain that are exacerbated by lumbar extension and relieved in flexion. If back pain is also present it must be partially relieved when the patient flexes.
• Diagnosis of NIC due to lumbar stenosis at 1 or 2 lumbar levels confirmed by X-ray, MRI or CT.
• Subject is a surgical candidate with disease severity justifying that BOTH laminectomy and X-STOP IPD placement are clinically appropriate treatment options.
• Subject is able to walk at least 50 feet.
• Subject is willing and able to comply with required follow-up testing and expected to be physically able to return for evaluation at scheduled follow-up visits.
• Subject is able to understand the risks and benefits of participating in the study.
• Subject understands and has signed the study informed consent form.

You may not qualify if:

• Spinal stenosis involving more than 2 lumbar levels.
• Any previous lumbar spine surgery.
• Subject has unremitting pain in any spinal position or axial back pain only without leg/buttock/groin pain.
• Evidence that subject's symptoms are due to vascular claudication.
• Subject has significant instability of the lumbar spine, e.g., isthmic spondylolisthesis or degenerative spondylolisthesis greater than Grade 1 (on a scale of 1 to 4).
• Subject has an ankylosed segment at the affected level(s).
• Subject has significant scoliosis (Cobb angle is greater than 25 degrees).
• Subject has cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction.
• Subject has a fixed motor deficit or known peripheral neuropathy.
• Subject has a degenerative neurologic disease.
• Subject has any mass lesions (e.g. disc herniations, synovial cysts, spinal tumors).
• Any evidence of spinal or systemic infection.
• Subject has a history of spinous process fracture or pars interarticularis fracture.
• Subject has history or radiographic evidence of 1 or more osteoporotic fractures (e.g., vertebral, hip, wrist) OR subject has severe osteoporosis of the spine or hip, defined as bone mineral density (BMD) in the spine or hip more than 2.5 SD below the mean of adult normals. If the Investigator suspects osteoporosis, a DEXA scan should be done.
• Subject has a known allergy to the implant materials (this includes titanium or titanium alloy and polyetheretherketone for X-STOP IPD).

Sponsors & Collaborators

• Medtronic Spine LLC: lead

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Laminectomy

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Decompression, Surgical; Surgical Procedures, Operative; Neurosurgical Procedures

Study Officials

• Volker Sonntag, MD

  Barrow Neurological Institute, St. Joseph's Hospital and Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2007
• First Posted: November 14, 2007
• Study Start: November 1, 2007
• Study Completion: November 1, 2011
• Last Updated: December 8, 2017

Record last verified: 2012-01