Study of OP-1 Putty in Uninstrumented Posterolateral Fusions

Trial ID or NCT#

NCT00678353

Status

not recruiting iconNOT RECRUITING

Purpose

This study is to provide additional data to support the safety and efficacy of OP-1 Putty as a replacement for autograft in patients undergoing posterolateral spinal fusion.

Official Title

Prospective Data Collection From the Stryker Biotech Pivotal IDE Study of OP-1 Putty in Uninstrumented Posterolateral Fusions

Eligibility Criteria

Ages Eligible for Study: 18 to 85
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. The patient was treated in Stryker Biotech clinical protocol S01-01US (Pivotal IDE study) and not a retreatment failure at the time of completion.2. The patient or legal guardian is willing and able to understand, sign and date the study specific Patient Informed Consent.3. The patient agrees to complete the necessary clinical and radiographic evaluations.
    1. Exclusion Criteria:
  2. 1. There are no exclusion criteria for participation in this protocol.
Exclusion Criteria:
  1. 1. There are no exclusion criteria for participation in this protocol.
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