Study of OP-1 Putty in Uninstrumented Posterolateral Fusions

Olympus Biotech Corporation202 enrolled

Overview

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.

Follow-up study 06-UPLF-01 was a prospective collection of longer-term data on the patient population from pivotal study S01-01US, and was conducted to expand the information regarding efficacy, particularly with regard to radiographic assessment of fusion, as well as the longer-term safety of OP-1 Putty in uninstrumented posterolateral fusion (PLF) as compared to autograft

Study Type

OBSERVATIONAL

Enrollment

202

Conditions

Degenerative Lumbar Spondylolisthesis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 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. Exclusion Criteria: 1\. There are no exclusion criteria for participation in this protocol.

Locations (22)

Unnamed facility

Santa Monica, California, United States

Unnamed facility

Stanford, California, United States

Outcomes

Primary Outcomes

Evidence of bone by CT scan

Time frame: 3+ years post-treatment from the Pivotal study S01-01US

Secondary Outcomes

Re-assessments of all clinical parameters from S01-01US

Time frame: 3+ years post-treatment from the Pivotal study S01-01US

Data from ClinicalTrials.gov

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