A Pilot Study of a Single Intra-articular Injection of Autologous Protein Solution in Patients With Knee Osteoarthritis

Zimmer Biomet1 site in 1 country11 target enrollmentNovember 2014

ConditionsOsteoarthritis, Knee

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Osteoarthritis, Knee
Sponsor: Zimmer Biomet
Enrollment: 11
Locations: 1
Primary Endpoint: Adverse Events
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to assess the safety of a single injection of APS.

Detailed Description

The primary objective of this study is to assess the safety of a single injection of APS in patients with painful unilateral knee osteoarthritis and who have not been able to get satisfactory pain relief with other treatments through one-month post treatment and monitor subjects for adverse events through 12 months.

Registry

clinicaltrials.gov

Start Date

November 2014

End Date

October 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Zimmer Biomet

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female ≥40 and ≤75 years old at time of injection..
•A standing radiograph of the knee showing a Kellgren-Lawrence grade of 2 to 4 (within 6 months of screening).
•Body mass index ≤40 kg/m
•A Western Ontario and McMaster Universities osteoarthritis index using the Likert scale, Version
•(WOMAC LK 3.1) pain subscale total score ≥ 10 and ≤
•Has undergone at least two prior conservative OA therapies without satisfactory pain relief.
•Patient has failed to get satisfactory pain relief from either HA or steroid injections or would be considered an appropriate patient to receive either HA or steroid injections

Exclusion Criteria

•Presence of active infection or abnormal effusion in the knee immediately preceding treatment injection.
•Presence of symptomatic OA in the non-study knee
•Diagnosed with rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, chondromalacia, arthritis secondary to other inflammatory diseases, or of metabolic origin; HIV, viral hepatitis; chondrocalcinosis, Paget's disease, villonodular synovitis, and other non-OA joint disease.
•Disease of spine, hip or other lower extremity joints of sufficient degree to affect assessment of the index knee
•Untreated symptomatic injury of index knee (e.g., acute traumatic injury, anterior cruciate ligament injury, meniscus injury, cartilage lesion).
•Knee radiographs showing bone-on-bone or other gross cartilage deficits.
•Presence of surgical hardware or other foreign body in the index knee.
•Intra-articular steroid injections in the index knee within 3 months of screening.
•Intra-articular HA in the index knee within 6 months of screening.
•Other intra-articular therapy in the index knee within 6 months prior to screening.

Outcomes

Primary Outcomes

Adverse Events

Time Frame: 1 Year

Adverse Events and Serious Adverse Events

Secondary Outcomes

Change From Baseline to 12 Months in Pain, Stiffness, and Function in Daily Living Measured With WOMAC Questionnaire(12 months)
Change From Baseline to 12 Months in Pain as Measured by the Numeric Rating Scale (NRS)(12 months)
Change From Baseline to 12 Months in Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS)(12 months)