A Prospective Single-Center Clinical Study of a Single Intra-Articular Injection of Autologous Protein Solution ("APS(TM)") in Patients With Osteoarthritis (OA) of the Knee

Zimmer Biomet1 site in 1 country11 target enrollmentMarch 2013

ConditionsGonarthrosis Knee Osteoarthritis Osteoarthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gonarthrosis
Sponsor: Zimmer Biomet
Enrollment: 11
Locations: 1
Primary Endpoint: Number of Adverse Events
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This prospective single-center study will evaluate the safety and tolerability of a single dose of "APS(TM)" treated patients with OA of the knee who have failed conservative OA therapy. The study will also evaluate efficacy by assessing patient pain and functionality.

Registry

clinicaltrials.gov

Start Date

March 2013

End Date

June 2014

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Zimmer Biomet

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Number of Adverse Events

Time Frame: Up to 6 months post-injection

Safety and tolerability will be assessed from AEs and injection-site reactions, physical examinations, knee examinations, vital signs, ECGs, and clinical laboratory tests (hematology, coagulation, blood chemistry, and urinalysis) evaluated at baseline (pre-injection) and post-injection up to 6 months.