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

NCT ID: NCT00939406

Last Updated: 2012-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-11-30

Brief Summary

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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

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Conditions

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Degenerative Spinal Stenosis Disk Herniation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Hyalospine

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

Group Type EXPERIMENTAL

Hyalospine

Intervention Type DEVICE

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

Interventions

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Hyalospine

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AO Clinical Investigation and Publishing Documentation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Pavlov, MD

Role: PRINCIPAL_INVESTIGATOR

Sint Maartenskliniek, Nijmegen, The Netherlands

Locations

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Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie, BG Unfallklinik Frankfurt/Main

Frankfurt, , Germany

Site Status

Sint Maartenskliniek, Nijmegen, The Netherlands

Woerden, , Netherlands

Site Status

Klinik Sonnehof

Bern, Canton of Bern, Switzerland

Site Status

Countries

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Germany Netherlands Switzerland

Other Identifiers

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Hyalospine

Identifier Type: -

Identifier Source: org_study_id