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Completed

NCT Number: NCT00939406

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

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.

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Key information

Conditions

Degenerative Spinal Stenosis Bone Diseases Disk Herniation Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyalospine

Device

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

Primary outcomes

  1. Rate of adverse events

    Time frame: 6 months

  2. Extent of epidural fibrosis

    Time frame: 12 months

Secondary outcomes

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

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

AO Clinical Investigation and Publishing Documentation

Other

Registry information

Official study title

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

Acronym: Hyalospine

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 15, 2009
Registry last updated
Dec 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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