Study of OP-1 Putty in Uninstrumented Posterolateral Fusions

Olympus

Status: Completed

Conditions: Degenerative Lumbar Spondylolisthesis

Study type: Observational

Funder types: Industry

Identifiers

NCT00678353

06-UPLF-01

Details and patient eligibility

About

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.

Full description

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

Enrollment: 202 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

202 participants in 1 patient group

1

Description:

Follow-up to S01-01US, conducted to expand information