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

Degenerative Spinal Stenosis Clinical Trial

— Hyalospine  

Official title:

A Multi-center Prospective Randomized Phase II Clinical Trial to Evaluate Safety and Efficacy of Hyalospine® in Lumbar Laminectomy or Laminotomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00939406
• Other study ID #: Hyalospine
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 14, 2009
• Last updated: December 19, 2012
• Start date: November 2009
• Est. completion date: November 2012

Study information

• Verified date: December 2012
• Source: AO Clinical Investigation and Documentation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionSwitzerland: SwissmedicGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesNetherlands: Medical Ethics Review Committee (METC)Netherlands:Health care inspectorate
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Degenerative Spinal Stenosis
• Disk Herniation
• Spinal Stenosis

Intervention

Device:
• Hyalospine
Intervention group consists of subjects randomized to the treatment arm who will receive lumbar decompression surgery (laminotomy or laminectomy) and HyaloSpine.

Locations

Country	Name	City	State
Germany	Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie, BG Unfallklinik Frankfurt/Main	Frankfurt
Netherlands	Sint Maartenskliniek, Nijmegen, The Netherlands	Woerden
Switzerland	Klinik Sonnehof	Bern

Sponsors (1)

Lead Sponsor	Collaborator
AO Clinical Investigation and Documentation

Countries where clinical trial is conducted

Germany,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of adverse events		6 months	Yes
Primary	Extent of epidural fibrosis		12 months	No
Secondary	differences in pain, neurological status, neurological symptoms, function, quality of life, patient satisfaction, immunologic and clinical laboratory results		12 months	No