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

AO Clinical Investigation and Publishing Documentation45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Degenerative Spinal Stenosis Disk Herniation

Interventions

HyalospineDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (3)

Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie, BG Unfallklinik Frankfurt/Main

Frankfurt, Germany

Sint Maartenskliniek, Nijmegen, The Netherlands

Woerden, Netherlands

Klinik Sonnehof

Bern, Canton of Bern, Switzerland

Outcomes

Primary Outcomes

Rate of adverse events

Time frame: 6 months

Extent of epidural fibrosis

Time frame: 12 months

Secondary Outcomes

differences in pain, neurological status, neurological symptoms, function, quality of life, patient satisfaction, immunologic and clinical laboratory results

Time frame: 12 months

Data from ClinicalTrials.gov

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