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

20:32 EDT 20th October 2014 | BioPortfolio

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.

Study Design

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

Conditions

Degenerative Spinal Stenosis

Intervention

Hyalospine

Location

Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie, BG Unfallklinik Frankfurt/Main
Frankfurt
Germany
60389

Status

Recruiting

Source

AO Clinical Investigation and Documentation

Results (where available)

View Results

Links

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Medical and Biotech [MESH] Definitions

Narrowing of the spinal canal.

A pathological constriction that can occur above (supravalvular stenosis), below (subvalvular stenosis), or at the AORTIC VALVE. It is characterized by restricted outflow from the LEFT VENTRICLE into the AORTA.

A degenerative spinal disease that can involve any part of the VERTEBRA, the INTERVERTEBRAL DISK, and the surrounding soft tissue.

The ratio of maximum blood flow to the MYOCARDIUM with CORONARY STENOSIS present, to the maximum equivalent blood flow without stenosis. The measurement is commonly used to verify borderline stenosis of CORONARY ARTERIES.

Outgrowth of immature bony processes or bone spurs (OSTEOPHYTE) from the VERTEBRAE, reflecting the presence of degenerative disease and calcification. It commonly occurs in cervical and lumbar SPONDYLOSIS.

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