Overview

This trial is active, not recruiting.

Condition osteoarthritis, knee
Treatments aps, placebo
Phase phase 2
Sponsor Biomet, Inc.
Start date May 2014
End date October 2015
Trial size 46 participants
Trial identifier NCT02138890, BBI.CR.APS1.14

Summary

This double-blind, multicenter, randomized, controlled trial (RCT) will evaluate the efficacy of a single dose of Autologous Protein Solution (APS) in patients with osteoarthritis (OA) of the knee who have failed at least 1 conservative osteoarthritis (OA) therapy (e.g. physiotherapy, simple analgesics, intra-articular injection).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Autologous Protein Solution
aps
Intra-articular Injection
(Placebo Comparator)
Placebo
placebo
Intra-articular injection

Primary Outcomes

Measure
Visual Analogue Scale - Pain
time frame: 60 Month

Secondary Outcomes

Measure
Knee injury and Osteoarthritis Outcome Score - Function
time frame: 60 months
Knee injury and Osteoarthritis Outcome Score - Stiffness
time frame: 60 months
Radiographic Imaging - Joint Structure
time frame: 24 months
Quality of Life Questionnaires (QoL)
time frame: 60 months
Number of patients with adverse events (Safety)
time frame: 60 months

Eligibility Criteria

Male or female participants from 40 years up to 75 years old.

Inclusion Criteria: - Male or female ≥40 years and ≤75 years. - Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions. - Diagnosis of knee osteoarthritis (OA) Grade 2 or 3 according to the Kellgren-Lawrence scale - Body mass index (BMI) ≤ 40. - Failed at least 1 conservative OA therapy - Signed an independent ethics committee (IEC) approved informed consent form (ICF). Exclusion Criteria: - Intra-articular Hyaluronic (HA) injection within 6 months

Additional Information

Official title A Multicenter, Double-Blind, Randomized, Placebo-Controlled Pilot Study of a Single, Intra-Articular Injection of Autologous Protein Solution (APS) in Patients With Osteoarthritis (OA) of the Knee
Principal investigator E. Kon, MD
Description A double-blind, multicenter, randomized, controlled trial (RCT) that will evaluate the efficacy of a single dose of Autologous Protein Solution (APS) in patients with Osteoarthritis (OA) of the knee who have failed at least 1 conservative OA therapy (e.g. physiotherapy, simple analgesics, intra-articular injection).
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Biomet, Inc..