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Comparative Evaluation of A-CP HA Kit, Hyaluronic Acid and Placebo for the Treatment of Knee Osteoarthritis

NCT03201614 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2020-12-21

No results posted yet for this study

Summary

Hyaluronic acid (HA) is a major component of synovial fluid, to which it confers viscosity and elasticity. It has been shown that the rheological properties of the synovial fluid decrease in patients with osteoarthritis. Intra-articular injections of hyaluronic acid represents a commonly used therapeutic option to relieve osteoarthritic symptoms, by exerting a mechanical action on cartilaginous structures of the joints, thus leading to reduced pain and improved joint function.

Platelet-rich Plasma is an autologous product prepared from the patient's own blood. Potential benefits of platelet-rich plasma for the treatment of cartilage defects have been suggested by many in vitro and animal studies. There are an increasing number of clinical studies assessing the benefits of platelet rich plasma in the treatment of osteoarthritis, showing that platelet rich plasma improves symptoms with no serious adverse events reported.

On the basis of the above, HA and platelet-rich plasma have the potential to provide added benefits in osteoarthritis symptoms when combined, in particular in patients who have had previous intra-articular HA treatment but who are still experiencing pain. Preliminary evidence to this effect was presented at the 2014 Annual Congress of the French Rheumatology Society by a group of French investigators. Renevier and Marc enrolled patients who had not experienced adequate symptom relief from previous intra-articular HA treatment and treated them with HA plus platelet-rich plasma prepared using A-CP HA Kit. Of the 71 patients treated, approximately 90% were classified as responders based on the OMERACT-OARSI criteria.

The A-CP HA Kit allows for the preparation of a homogenous solution of platelet-rich plasma and HA, intended to be injected intra-articularly for the treatment of pain in osteoarthritis. In patients who had previous intra-articular HA treatment but who are still experiencing pain, treatment with HA plus platelet rich plasma could provide a safe and reproducible option before surgery.

Conditions

Interventions

DEVICE

A-CP HA Kit

Patients randomized in this group will receive two injections of platelet-rich plasma/hyaluronic acid prepared with the A-CP HA Kit at Day 0 and Month 2

DEVICE

ArthroVisc 40

Patients randomized in this group will receive two injections of hyaluronic acid only (ArthroVisc 40) at Day 0 and Month 2

DRUG

Placebo

Patients randomized in this group will receive two injections of a saline placebo at Day 0 and Month 2

Sponsors & Collaborators

  • Regen Lab SA

    lead INDUSTRY

Principal Investigators

  • Bert Mandelbaum, MD · Santa Monica Orthopaedic & Sports Medicine Group

  • Nicholas Sgaglione, MD · Northwell Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-22
Primary Completion
2022-04-30
Completion
2022-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03201614 on ClinicalTrials.gov