Evaluation of Intra-articular Injection of Autologous Protein Solution ("APS(TM)") for the Treatment of Osteoarthritis (OA)

Zimmer Biomet

Status: Completed

Conditions: Osteoarthritis; Gonarthrosis; Knee Osteoarthritis

Treatments: Device: Autologous Protein Solution "APS(TM)"

Study type: Interventional

Funder types: Industry

Identifiers

NCT01773226

APSS-11-00

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility Criteria:

• Male or female ≥40 years.
• Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions.
• A standing radiograph of the knee showing a Kellgren grade of 2 or 3
• Frequency of knee pain on most days over the last month.
• Diagnosis of unilateral knee OA
• Body mass index (BMI) ≤40 kg/m2.
• Failed conservative OA therapy.
• Signed an independent ethics committee (IEC)-approved informed consent form (ICF).
• Willingness to abstain from the use of topical pain therapies, intra-articular corticosteroids, and viscosupplementation during the study.
• Willingness to abstain from systemic pain medications except rescue medication.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Autologous Protein Solution "APS(TM)"

Experimental group

Description:

Patients who have been treated with a single, intra-articular injection.

Treatment:

Device: Autologous Protein Solution "APS(TM)"