Health TrialsbyHealthPanel

Study to Evaluate a New Cartilage Regeneration Platform for Knee Cartilage Repair

ConditionCartilage Defects of the Knee
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19-64
SponsorROKIT Healthcare

About this trial

The goal of this clinical trial is to learn if a new treatment works to help regrow knee cartilage in people with knee cartilage damage. The main questions it aims to answer are:

Does the treatment help the knee work better and lower pain more than the standard surgery?

Is the treatment safe and does it help grow stronger new cartilage?

Researchers will compare participants who get the standard surgery (microfracture) to participants who get both the standard surgery and the new treatment. This is to see if the new treatment leads to a better and faster recovery.

Participants will:

Have a surgery to treat their knee cartilage damage.

Visit the clinic for check-ups to see how well their knee moves.

Take imaging tests, like an MRI, so researchers can look at the new cartilage.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 19 years to <65 years at the time of consent.

Cartilage lesion severity of the target knee is ICRS grade 3 or 4.

Focal cartilage defect size in the target knee is ≥5 cm² and ≤10 cm².

The target knee is clinically considered to require microfracture, or microfracture with high tibial osteotomy (HTO).

Disqualifiers

Traumatic or secondary osteoarthritis (Secondary OA) in the target knee.

Inflammatory arthritis in the target knee (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, systemic lupus erythematosus, gout, pseudogout, Behçet's disease, etc.).

Currently receiving immunosuppressive therapy or having a serious systemic disease (e.g., severe cardiovascular disease; long-term use of immunosuppressants; cancer patient receiving chemotherapy; systemic autoimmune disease; severe liver or kidney disease; uncontrolled endocrine disease, etc.).

Advanced severe osteoarthritis in the target knee (Kellgren-Lawrence [KL] grade 4).

Trial design

Design model

Parallel

Treatments tested in this trial

  • MAECM transplantation

    Procedure/Surgery

    This intervention is a multi-step, autologous tissue-based regenerative procedure. Arthroscopic debridement is first performed at the focal cartilage defect. Microfracture is then performed at the defect bed according to standard technique. Infrapatellar fat pad (IFP) tissue is subsequently harvested through a small incision. The harvested autologous tissue is processed intra-operatively to generate micronized autologous ECM and prepared as a printable formulation. A patient-specific patch is fabricated using a 3D bioprinting system and implanted to cover the focal cartilage defect. The study evaluates patch integration and regenerative outcomes following implantation.

  • Micronfracture

    Procedure/Surgery

    This intervention consists of arthroscopic debridement of the focal cartilage defect followed by microfracture performed at the defect bed according to standard technique. The study evaluates clinical and structural outcomes following microfracture.

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: TestExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) total score at 1year

Time frame
Baseline to 12 months

Secondary outcomes

1

Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) total score, assessed at 3, 6, and 9 months

Time frame
Baseline, 3 months, 6 months, and 9 months
2

Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score assessed by an independent evaluator at 6 and 12 months

Time frame
Baseline, 6 months, and 12 months
3

Change from baseline in 100-mm Visual Analog Scale (VAS) pain score at 3, 6, 9, and 12 months

Time frame
Baseline, 3 months, 6 months, 9 months, and 12 months
4

Change from baseline in International Knee Documentation Committee (IKDC) score at 3, 6, 9, and 12 months

Time frame
Change from baseline in IKDC

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ROKIT Healthcare

Lead sponsor

Source ClinicalTrials.gov
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