New donor cartilage implant aims to fix knee damage in one surgery
NCT ID NCT03873545
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a special donor tissue called ProChondrix CR to repair damaged knee cartilage in 34 adults aged 18 to 60. The tissue is implanted during surgery to help reduce pain and improve knee function over 5 years. Researchers will track changes in pain, movement, and quality of life to see if this single-step approach works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ProChondrix CR (cryopreserved donor cartilage and bone tissue)
- What this could lead to
- If it works, this could provide a single-step surgical option to repair knee cartilage damage, reducing pain and improving mobility without needing multiple procedures.
- What could go wrong
- This is a small, early-stage study with only 34 participants, so results may not apply to everyone. The implant may fail to integrate or symptoms may not improve significantly.
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.
- Participants
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34 people
The number who actually took part.
- Started
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Mar 2019
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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.
Who is studied
Skeletally mature patients between the ages of ≥18 and ≤ 60 who have a symptomatic cartilage defect (Grade 3 or 4) on the femoral condyle or patella, in a mechanically stable knee, or is being mechanically stabilized in the same procedure, between ≥ 1 cm2 and ≤ 5 cm2, measured as a rectangle length x width, as confirmed by MRI or arthroscopy.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Patient is ≥18 and ≤ 60 years old at the time of surgery; * Symptomatic patient presenting with moderate to severe pain in the index knee - unresponsive to conservative treatment (i.e. medication, bracing, physical therapy) and/or previous surgical intervention; * Radiographically diagnosed, by MRI, or through arthroscopy, to have a cartilage defect on the femoral condyle or patella between ≥ 1 cm2 and ≤ 5 cm2, measured as a rectangle length x width; * Will be having a marrow stimulation plus ProChondrix CR procedure; * Has an intact meniscus (maximum of ≤50% resected); * Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol. Exclusion Criteria: * Has \> 5° of varus or valgus deformity; * Bipolar articular cartilage involvement (kissing lesions) of the ipsilateral compartment (i.e. \> than ICRS Grade 2 on the opposing articular surface); * Associated damage to the underlying subchondral bone \>2 mm requiring osseous repair; * Requires concomitant ligament repair other than Anterior Cruciate Ligament (ACL) or Medial Patella-Femoral Ligament (MPFL) reconstruction; * Body Mass Index (BMI)of ≥ 35 kg/m2; * Active malignancy: undergoing treatment for tumor or boney traumatic injury or a history of any invasive malignancy (except non-melanoma skin cancer), unless the patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years; * Clinical and/or radiographic disease in the affected joint that includes: osteoarthritis or avascular necrosis, gout or a history of gout or pseudogout, osteochondritis dissecans with significant bone loss; * Cartilage lesion location such that the implanted graft will not be adequately shouldered; * Active local microbial infection or a systemic infection, including prior or pending treatment for HIV, syphilis, Hepatitis B or Hepatitis C; * Currently immunologically suppressed or immunocompromised, or a medical condition requiring radiation, chemotherapy or immunosuppression; * Unstable cardiovascular, renal, hepatic, endocrine and/or pulmonary disease, cancer or uncontrolled diabetes; * Has a history of any inflammatory or connective tissue disease, such as, systemic lupus erythematosus (SLE), Addison's disease, Crohn's disease, multiple sclerosis, polychondritis or rheumatoid arthritis; * Received hyaluronic acid injections into the joint space ≤ 90 days prior to surgery; * Is a female patient who is pregnant; * Physically or mentally compromised (i.e. being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease) in a manner that would compromise his/her ability to participate in the clinical study; * Has a history of substance abuse (recreational drugs, alcohol) or has been treated in the last 6 months before enrollment for alcohol and/or drug abuse in an in-patient substance abuse program; * Patients who, in the opinion of the Investigator, would not be able or willing to comply with the protocol; * Is currently involved in a study of another investigational product for similar purpose or has been in the previous 90 days; * Has any contraindications for MRI; * Is a ward of the state, prisoner, or transient.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beacon Orthopaedics & Sports Medicine
Cincinnati, Ohio, 45247, United States
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Midwest Orthopaedics at Rush
Chicago, Illinois, 60612, United States
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University of Kentucky Research Foundation
Lexington, Kentucky, 40506, United States
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