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

AO Clinical Investigation and Publishing Documentation

Status and phase: Completed; Phase 3; Phase 2

Conditions: Degenerative Spinal Stenosis; Disk Herniation

Treatments: Device: Hyalospine

Study type: Interventional

Funder types: Other

Identifiers

NCT00939406

Hyalospine

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 2 patient groups

Control

No Intervention group

Description:

Control group consists of subjects randomized to the control arm who will receive lumbar decompression surgery (laminotomy or laminectomy) alone

Hyalospine

Experimental group

Description:

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

Treatment:

Device: Hyalospine