Clinical Efficacy of Platelet-Rich Plasma and Hyaluronic Acid Versus Hyaluronic Acid for Knee Osteoarthritis with MRI Analysis

NCT06636695 | Completed Phase 3 DMC

• 1 other identifier: 2020-2035
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The study hypothesizes that the combination of Cellular Matrix PRP-HA is superior to Hyaluronic Acid (HA) alone, specifically from the Orthovisc Kit, in relieving pain and function associated with knee osteoarthritis. The primary objective is to assess pain reduction following treatment. The secondary objectives, includes assessing the treatment's impact on function, stiffness, and overall quality of life for patients. In addition, non-invasive MRI will be employed at baseline and 12 months to evaluate changes in bone marrow edema, cartilage structure, and joint effusion. The study also aims to compare the safety of Cellular Matrix PRP-HA and HA.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Pain score

  Visual Analogue Score (VAS) on a scale of 0 to 10. 10 being the worst possible pain.

  Baseline, Month 1, Month 2, Month 6, Month 12

Secondary Outcomes (3)

• Quality of life

  Baseline, Month 1, Month 2, Month 6, Month 12

• MRI

  Baseline and Month 12

• Function Score

  Baseline, Month 1, Month 2, Month 6, Month 12

Study Arms (2)

PRP and HA

EXPERIMENTAL

Cellular-Matrix

Device: Cellular Matrix

HA

ACTIVE COMPARATOR

Orthovisc

Device: Orthovisc

Interventions

Cellular Matrix DEVICE

Group 1 (Cellular Matrix): Patients randomized to this group will be treated with two intra-articular injections of Cellular Matrix at D0 and M1.

PRP and HA

Orthovisc DEVICE

Group 2 (HA): Patients randomized to this group will be treated with two intra-articular injections of HA alone provided by ORTHOVISC at D0 and M1

HA

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 40 and 80 years (inclusive) of age
• Femoro-tibial knee osteoarthritis defined
• OA grade 2-3 according to the Kellgren \& Lawrence grading scale, as defined on knee radiographs (less than 6 months old: Antero-posterior view; lateral view and skyline view)
• Symptomatic knee osteoarthritis of a unilateral knee, characterized by pain at walking VAS ≥40 on a 0 to 100mm scale
• \*Bilateral knee osteoarthritis is allowed, provided the contralateral knee is characterized by a maximum pain at walkingof 30 on a 0 to 100 mm scale and doesn't require systemic analgesic treatment, with the exception of paracetamol up to the maximum dose of 4 g per day
• Outpatient capableof walking 50 meters without assistance
• Signature of the informed consent form
• Capable of understanding the study's imperatives, as well as written instructions

You may not qualify if:

• Grade \< 2 or \> 3 OA according to the Kellgren \& Lawrence gradingscale
• Viscosupplementation in the treatment site within the past 3 months
• Patients suffering from femoropatellar osteoarthritis
• Use of NSAIDs within the past 7 days
• Corticosteroid injection in the treatment site within the past 3 months
• Chronic use of corticosteroids (except those that are inhaled) or level III analgesics in the past 3 months and NSAID during the past month2 weeks
• PRP or PRP/HA injection in the past 12 months
• Any surgery of the knee planned within the next 12 months
• Unstable knee injury
• Systemic use of level III analgesics in the past 3 months
• History of allergy to HA
• Rheumatological disorders(exceptKOA)
• Clinical evidence of local inflammation such as redness or heat of the joint
• Current or medical history of autoimmunediseases
• Surgery or arthroscopy surgery in the affected knee within the past 3 months

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Changi General Hospital

Singapore, Singapore, 529889, Singapore

Location

Related Publications (7)

• Campbell KA, Saltzman BM, Mascarenhas R, Khair MM, Verma NN, Bach BR Jr, Cole BJ. Does Intra-articular Platelet-Rich Plasma Injection Provide Clinically Superior Outcomes Compared With Other Therapies in the Treatment of Knee Osteoarthritis? A Systematic Review of Overlapping Meta-analyses. Arthroscopy. 2015 Nov;31(11):2213-21. doi: 10.1016/j.arthro.2015.03.041. Epub 2015 May 29.

  PMID: 26033459 BACKGROUND

• Abate M, Verna S, Schiavone C, Di Gregorio P, Salini V. Efficacy and safety profile of a compound composed of platelet-rich plasma and hyaluronic acid in the treatment for knee osteoarthritis (preliminary results). Eur J Orthop Surg Traumatol. 2015 Dec;25(8):1321-6. doi: 10.1007/s00590-015-1693-3. Epub 2015 Sep 24.

  PMID: 26403468 BACKGROUND

• Barac, B., N. Damjanov, and A. Zekovic, The new treatment approach in knee osteoarthritis: Efficacy of cellular matrix combination of platelet rich plasma with hyaluronic acid versus two different types of hyaluronic acid (HA). Int. J. Clin. Rheumatol., 2018. 13(5): p. 289-295.

  BACKGROUND

• Pham T, van der Heijde D, Altman RD, Anderson JJ, Bellamy N, Hochberg M, Simon L, Strand V, Woodworth T, Dougados M. OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthritis Cartilage. 2004 May;12(5):389-99. doi: 10.1016/j.joca.2004.02.001.

  PMID: 15094138 BACKGROUND

• Renevier, J.L., et al., "Cellular matrix™ PRP-HA": A new treatment option with platelet-rich plasma and hyaluronic acid for patients with osteoarthritis having had an unsatisfactory clinical response to hyaluronic acid alone: Results of a pilot, multicenter French study with long-term follow-up. Int. J. Clin. Rheumatol., 2018. 13(4): p. 230-238.

  BACKGROUND

• LaBaze, D. and H. Li, Platelet Rich Plasma: Biology and Clinical Usage in Orthopedics, in Orthopedic Biomaterials : Progress in Biology, Manufacturing, and Industry Perspectives, B. Li and T. Webster, Editors. 2018, Springer International Publishing: Cham. p. 243-286.

  BACKGROUND

• Yu W, Xu P, Huang G, Liu L. Clinical therapy of hyaluronic acid combined with platelet-rich plasma for the treatment of knee osteoarthritis. Exp Ther Med. 2018 Sep;16(3):2119-2125. doi: 10.3892/etm.2018.6412. Epub 2018 Jul 6.

  PMID: 30186448 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 15, 2024
• Study Start: November 11, 2021
• Primary Completion: March 9, 2023
• Study Completion: March 30, 2023
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data available upon publication
• Access Criteria: Request to lead author

Locations

SG (1)