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Osteoarthritis, KneePhase 3NCT06636695

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

A Phase 3 study testing Cellular Matrix and Orthovisc in people with Osteoarthritis, Knee, run by Changi General Hospital at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
Cellular Matrix and Orthovisc
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteSingapore
Study dates
11 Nov 2021to 30 Mar 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants fulfilling all of the inclusion criteria, listed below, are eligible to participate in this study:
  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 28Show fewer
  • 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
  • Local infection in the affected knee
  • Haematologic or clotting disorders (thrombocytopenia platelet count <150,000 platelets/µ) or blood coagulation (deficit-blood dyscrasia)
  • Anaemia (Haemoglobin <10g/dl)
  • Anticoagulant treatment or Antiaggregant treatment
  • Acute infection
  • Immunosuppressive states
  • Malignant disease
  • Recent fever (within previous 2 weeks) or serious disorders (liver disease, active gastroduodenal ulcer, digestive haemorrhage, etc.)
  • Pregnancy or breastfeeding or planning to become pregnant during the course of the study
  • Uncontrolled diabeted
  • Participation ongoing or in the past 3 months in another clinical trial
  • Participation in another OA clinical study in the past year
  • Refusal to sign or inability to give Informed Consent Inability to understand or comply with the requirements of the study

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • Changi General Hospital

    Singapore, Singapore, 529889

Other trials in Singapore

About this study

Official title: Clinical Efficacy of Platelet-Rich Plasma and Hyaluronic Acid Versus Hyaluronic Acid for Knee Osteoarthritis With MRI Analysis: A Randomized Controlled Trial

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.

Being tested
Cellular Matrix, Orthovisc
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cellular MatrixDevice

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

  • OrthoviscDevice

    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

Study groups in NCT06636695
Study groupRoleWhat they receive
PRP and HAExperimentalCellular-Matrix
Receives: Device: Cellular Matrix
HAActive comparatorOrthovisc
Receives: Device: Orthovisc

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain score

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

    Measured: Baseline, Month 1, Month 2, Month 6, Month 12

Secondary outcomes (3)

  1. Quality of life

    EQ-5D-5L. It consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity: 1- no problem; 5- extreme problem

    Measured: Baseline, Month 1, Month 2, Month 6, Month 12

  2. MRI

    Whole-Organ Magnetic Resonance Imaging Score (WORMS). WORMS evaluates 14 specific features. Each feature is scored on a scale: 0 = Normal; 1-6 = Increasing severity of abnormalities.

    Measured: Baseline and Month 12

  3. Function Score

    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The total WOMAC score is calculated by summing the scores from all three subscales: Pain, Stiffness, Physical Function. This can range from a minimum of 0 (indicating no symptoms) to a maximum of 96 (indicating severe symptoms).

    Measured: Baseline, Month 1, Month 2, Month 6, Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2024
  2. Study start11 Nov 2021
  3. Primary completion9 Mar 2023
  4. Study completion30 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06636695
Sponsor's protocol ID
2020-2035
Status last verified
Oct 2024
First submitted
8 Oct 2024
Last updated
15 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 26033459

  • 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.

    PubMed 26403468

  • 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.

  • 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.

    PubMed 15094138

  • 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.

  • 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.

  • 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.

    PubMed 30186448

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cellular Matrix and Orthovisc in people with Osteoarthritis, Knee, run by Changi General Hospital at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain score (time frame: Baseline, Month 1, Month 2, Month 6, Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06636695, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.

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