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

NCT03201614 | Unknown DMC FDA Device

• 1 other identifier: RL 04
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief 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

Knee Osteoarthritis

Keywords

platelet-rich plasma, hyaluronic acid, knee osteroarthritis

Outcome Measures

Primary Outcomes (2)

• Variation in overall OA-related symptoms

  It will be assessed by the mean difference in total WOMAC score on a 100-mm VAS between baseline and Month 6

  6 Months

• Variation in pain at walking (WOMAC A1 score)

  II t will be assessed by the mean difference on a 100-mm VAS between baseline (D0) and Month 6

  6 Months

Secondary Outcomes (10)

• Variation in overall OA-related symptoms, between baseline (D0) and Month 1 (D30), Month 2, Month 3, Month 4, and Month 12

  12 Months

• Variation in pain at walking (WOMAC A1 score), between baseline (D0) and Month 1 (Day 30), Month 2, Month 3, Month 4, and Month 12

  12 Months

• Variation of general pain, between baseline (D0) and Month 1 (Day 30), Month 2, Month 3, Month 4, Month 6 and Month 12

  12 Months

• Variation of joint stiffness, between baseline (D0) and Month 1 (Day 30), Month 2, Month 3, Month 4, Month 6 and Month 12

  12 Months

• Variation of joint function, between baseline (D0) and Month 1 (Day 30), Month 2, Month 3, Month 4, Month 6 and Month 12

  12 Months

Study Arms (3)

A-CP HA

EXPERIMENTAL

Patients randomized in this group will be treated with a combination of platelet-rich plasma plus hyaluronic acid prepared with A-CP HA Kit.

Device: A-CP HA Kit

ArthroVisc 40

ACTIVE COMPARATOR

Patients randomized in this group will be treated with hyaluronic acid only (ArthroVisc 40); hyaluronic acid is the same as the one contained in the A-CP HA Kit.

Device: ArthroVisc 40

Placebo

PLACEBO COMPARATOR

Patients randomized in this group will be treated with a saline solution.

Drug: Placebo

Interventions

A-CP HA Kit DEVICE

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

A-CP HA

ArthroVisc 40 DEVICE

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

ArthroVisc 40

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Osteoarthritis grade 2-3 according to the Kellgren \& Lawrence grading scale, as defined on knee radiographs (less than 3 months old: face view, schuss view, profile and patellar axial view at 30°)
• Knee Pain level of at least 3 on the 0-10-point WOMAC A subscale
• Bilateral osteoarthritis provided that the contralateral knee has a pain no more than 2 on the 0-10 point scale, and not requiring systemic analgesic treatment except paracetamol until the maximum dose of 4g per day

You may not qualify if:

• Grade \<2 or \>3 OA according to the Kellgren and Lawrence grading scale
• Bilateral osteoarthritis provided that the contralateral knee has a pain more than 2 on the 0-10 point scale and requiring systemic analgesic treatment or paracetamol more than 4g per day
• Viscosupplementation in the treatment site in the past 3 months
• Corticosteroid injection in the treatment site in the previous 3 months
• Systematic use of corticosteroid (except those that are inhaled) within 3 months
• History of allergy to hyaluronic acid
• Rheumatological disorders
• Clinical evidence of local inflammation such as redness or heat of the joint
• Current or medical history of autoimmune disease
• Surgery or arthroscopy surgery in the affected knee in the past 3 months
• Local infection in the affected knee
• Hematologic or clotting disorders (thrombocytopenia) or blood coagulation (deficit-blood dyscrasia)
• Anaemia (Haemoglobin \< 10g/dl)
• Platelet count below 150/mmc
• Anticoagulant treatment

Sponsors & Collaborators

• Regen Lab SA: lead

Study Sites (1)

Bert Mandelbaum, MD

Santa Monica, California, 90404, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Bert Mandelbaum, MD

  Santa Monica Orthopaedic & Sports Medicine Group

  PRINCIPAL INVESTIGATOR

• Nicholas Sgaglione, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerie De Fourmestraux, PhD

CONTACT

+41(0)21 864 01 18; vdefourmestraux@regenlab.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: June 28, 2017
• Study Start: May 22, 2018
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: December 21, 2020

Record last verified: 2020-12

Locations

US (1)