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Knee implant shows promise in repairing cartilage damage

NCT ID NCT03299959

Disease control Sponsor: Smith & Nephew, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new implant called Agili-C for people with knee cartilage damage or early arthritis. 251 participants received either the implant or standard surgery. The goal was to see if the implant improved pain and function over 5 years. Results suggest it may be a helpful option for some patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Agili-C implant
What this could lead to
If successful, this implant could offer a better option for people with knee cartilage damage, reducing pain and improving mobility without needing a full knee replacement.
What could go wrong
This is a completed trial, but results may not apply to everyone. The implant is a device, so risks include infection, implant failure, or no improvement over standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

251 people

The number who actually took part.

Started

Sep 2017

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 21 -75 years 2. Up to 3 treatable joint surface lesion(s), ICRS Grade III or above, on the femoral condyles and/or trochlea 3. Symptomatic total treatable area 1-7 cm2. Asymptomatic lesions will not be included in the calculation 4. Must be physically and mentally willing and able to comply with the post-operative rehabilitation protocol and scheduled clinical and radiographic visits 5. Signed and dated the IRB/Ethics Committee approved Informed Consent Form and HIPPA (if applicable) 6. Non-responsive to physical therapy for at least 3-4 weeks Exclusion Criteria: 1. KOOS Pain Subscale score at baseline is less than 20 or more than 65 (scale: maximum pain =0, pain free =100) 2. Bony defect depth deeper than 8mm, according to baseline MRI/X-ray/arthroscopy 3. Articular cartilage lesions in the tibia or the patella, ICRS grades IVa or above 4. Osteoarthritis of the index knee graded 4 according to the Kellgren-Lawrence Grading 5. Significant instability of the index knee according to IKDC Knee Examination Form 2000, Grade C (abnormal) or D (severely abnormal) 6. Malalignment more than 8 degrees varus OR 8 degrees valgus according to standing X-ray 7. Lack of functional remaining meniscus, at least 5mm rim at the end of the procedure 8. Meniscal transplantation in the past 6 months 9. Any known tumor of the index knee 10. Any known history of intra-articular or osseous infection of the index knee 11. Any evidence of active infection anywhere in the body. Urinary Tract Infection (UTI) patients can be included following antibiotic treatment, and provided that two consecutive cultures are negative (taken within at least 2 weeks of each other) 12. Any known history of inflammatory arthropathy or crystal-deposition arthropathy 13. Any known systemic cartilage and/or bone disorder, such as but not limited to, osteoporosis, chondrodysplasia or osteogenesis imperfecta 14. Body Mass Index (BMI) \> 35 15. Chemotherapy in the past 12 months 16. Any previous surgical cartilage treatment (such as: microfracture, ACI, OATS, etc.) in the index knee within the last 6 months 17. Any previous ligamentous repair or malalignment correction in the index knee within the last 6 months 18. History of allergic reaction or intolerance of materials containing calcium carbonate or hyaluronate 19. Patient who is pregnant or intends to become pregnant during the study 20. History of any significant systemic disease, such as but not limited to: HIV, hepatitis, HTLV, syphilis, and coagulopathies 21. Known substance or alcohol abuse 22. Participation in other clinical trials within 60 days prior to the study or concurrent with the study 23. Known insulin dependent diabetes mellitus 24. Unable to undergo either MRI or X-ray 25. Use of anticoagulation medication or antiaggregant medication; however up to 100 mg Acetylsalicylic acid (ASA) daily is allowed 26. Previous intra-articular steroid injection within the last 1 month 27. Prisoners 28. Uncontained lesion - Lack of vital bone wall, at least 2mm thick, completely surrounding the lesion - based on MRI/X-ray/arthroscopy 29. Inability to position the implant 2mm recessed relative to the articular surface - based on MRI/X-ray/arthroscopy

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Conditions

The condition(s) this trial relates to.

osteoarthritis osteoarthritis, knee osteochondritis dissecans

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cartilage or osteochondral defects in the knee Up to moderate osteoarthritis

Contacts and locations

Locations

  • "Carmel" Medical Center

    Haifa, 3436212, Israel

  • AZ Monica

    Antwerp, Belgium

  • Arlington Orthopedic Associates

    Arlington, Texas, 76015, United States

  • Assaf Harofeh Medical Center

    Be’er Ya‘aqov, 60930, Israel

  • Atlas General hospital

    Belgrade, Serbia

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02467, United States

  • Clinic for Orthopedic Surgery "Banjica"

    Belgrade, Serbia

  • Clinical Center of Vojvodina

    Novi Sad, Serbia

  • County Hospital Timis Othopedy and Trauma Clinic

    Timișoara, Romania

  • Hadassah Medical Center

    Jerusalem, Israel

  • Hasharon Hospital, Petach Tikva

    Petah Tikva, Israel

  • Horizon Clinical Research

    San Diego, California, 91942, United States

  • Hospital for Special Surgery

    New York, New York, 10021, United States

  • Humanitas Gavazzeni

    Bergamo, Italy

  • Istituto Clinico Humanitas

    Rozzano, Italy

  • Kastélypark Klinika

    Tata, 2892, Hungary

  • LSU Healthcare Network Orthopedic & Sports Medicine

    New Orleans, Louisiana, 70112, United States

  • NYU Langone Orthopedic Hospital

    New York, New York, 10003, United States

  • Ohio State University, Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • OrthoVirginia

    Richmond, Virginia, 23294, United States

  • Peninsula Orthopaedic Associates

    Salisbury, Maryland, 21804, United States

  • Souraski Medical Center

    Tel Aviv, 6423906, Israel

  • Specialist Hospital. Louis Rydygier in Krakow

    Krakow, Poland

  • University of Missouri, Missouri Orthopaedic Institute

    Columbia, Missouri, 65212, United States

  • Uzsoki Utcai Kórház

    Budapest, 1114, Hungary

More trials for these conditions

Other studies related to the condition(s) this trial covers.