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An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation

Study:

An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation

Rationale:

n/a

Purpose:

The aim of this trial is to evaluate if P-15 bone putty (investigational device) is not inferior in effectiveness and safety to local autologous bone (control device) when applied in instrumented anterior cervical discectomy and fusion (ACDF) with use of a structural allograft ring in patients with degenerative cervical disc disease..

Study Status: Active, not recruiting

Recruiting:
n/a

Condition Intervention Phase
Degenerative Disc Disease in Cervical Spine Device: P-15 Synthetic osteoconductive bone substitute
Other: Autologous bone
Phase 3

Verified by AO Clinical Investigation and Documentation May, 2013

Sponsored by: AO Clinical Investigation and Documentation
Information provided by: AO Clinical Investigation and Documentation
ClinicalTrials.gov identifier: NCT00310440

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Cleveland Clinic
Cleveland, Ohio 44195
United States

Michael Janssen, MD / DO., Principal Investigator

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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