Clinical Trial to Evaluate Safety and Efficacy of Hyalospine® in Lumbar Laminectomy or Laminotomy

Phase 2

Completed

• Conditions: Degenerative Spinal Stenosis; Disk Herniation

• Registration Number: NCT00939406
• Lead Sponsor: AO Clinical Investigation and Publishing Documentation

Brief Summary

The aim of this Phase II trial is to evaluate safety and efficacy of Hyalospine in patients undergoing lumbar laminectomy or laminotomy for degenerative spinal stenosis or disk herniation. The device is used as an adjunct in lumbar spine surgery to prevent post- surgical fibrosis and adhesions, and improve patient outcomes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-14
• Study First Submitted QC: 2009-07-14
• Study First Posted: 2009-07-15
• Study Start: 2009-11
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-19
• Last Update Posted: 2012-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Scheduled for elective single- or two-level lumbar laminectomy or laminotomy procedure for treatment of spinal stenosis and/or disk herniation.
• Subjects who have failed conservative care for at least 6 weeks.

Exclusion Criteria

• Contraindication to MRI
• Instrumented fusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of adverse events	6 months
Extent of epidural fibrosis	12 months

Secondary Outcome Measures

Name	Time	Method
differences in pain, neurological status, neurological symptoms, function, quality of life, patient satisfaction, immunologic and clinical laboratory results	12 months

Trial Locations

Locations (3)

Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie, BG Unfallklinik Frankfurt/Main; 🇩🇪 Frankfurt, Germany

Sint Maartenskliniek, Nijmegen, The Netherlands; 🇳🇱 Woerden, Netherlands

Klinik Sonnehof; 🇨🇭 Bern, Switzerland