Cartilage InjuryNCT03873545
Prospective Evaluation of ProChondrix CR for Repair of Articular Cartilage Defects on Femoral Condyle and Patella
An observational study of Cartilage Injury and Cartilage Damage, run by AlloSource at 3 sites in United States.
Trial summary
The purpose of this clinical study is to evaluate the use of ProChondrix Cryopreserved Osteochondral Allograft to obtain evidence of effectiveness, defined as an improvement in physical function and pain, when used on a symptomatic cartilage defect on the femoral condyle or patella in a mechanically stable knee. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cartilage Injury, Cartilage Damage
- What is being tested?
- Cryopreserved Osteochondral Allograft
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Mar 2019to 30 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 20Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Midwest Orthopaedics at Rush
Chicago, Illinois, 60612
Beacon Orthopaedics & Sports Medicine
Cincinnati, Ohio, 45247
University of Kentucky Research Foundation
Lexington, Kentucky, 40506
About this study
Official title: A Prospective, Multi-Center Study Evaluating ProChondrix® CR for the Repair of Focal Articular Cartilage Defects in the Knee
The purpose of this clinical study is to evaluate the use of ProChondrix Cryopreserved Osteochondral Allograft to obtain evidence of effectiveness, defined as an improvement in physical function and pain, when used on a symptomatic cartilage defect on the femoral condyle or patella in a mechanically stable knee.
Read the detailed description
This clinical study will use a multi-center, prospective design, to evaluate ProChondrix CR in approximately 80 patients who are scheduled to undergo treatment of a cartilage defect on the femoral condyle or patella.Patient follow-up will include a period of 60 months after surgery. During this follow-up period, each patient will be evaluated seven (7) times at: 3, 6, 12, 24, 36, 48 and 60 months after surgical intervention.
- Conditions
- Cartilage Injury, Cartilage Damage
- Being tested
- Cryopreserved Osteochondral Allograft
- Keywords
- Cartilage, Cartilage Injury, Cartilage Repair, Cartilage Damage, Cartilage Lesion, Cartilage Defect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryopreserved Osteochondral AllograftProcedure or surgery
Also called ProChondrix CR
This tissue is a laser-etched, cryopreserved fresh osteochondral allograft that was developed as a single-stage alternative for articular cartilage restoration.
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective International Knee Documentation Committee (IKDC) Score
Change in physical pain and function as assessed by IKDC score from baseline to 60 months post-surgery
Measured: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
Secondary outcomes (3)
Knee injury and Osteoarthritis Outcome Score (KOOS)
Change of physical pain as assessed by KOOS score from baseline to 60 months post-surgery
Measured: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
SF-12 survey
Change in functional health and well-being as assessed by SF-12 survey from baseline to 60 months post-surgery
Measured: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Scores
Assessment of repair cartilage structure
Measured: 12, 24 and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start18 Mar 2019
- Primary completion1 Nov 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- AlloSource
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873545
- Sponsor's protocol ID
- PRO-002
- Status last verified
- Nov 2025
- First submitted
- 12 Mar 2019
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center Study Evaluating ProChondrix® CR for the Repair of Focal Articular Cartilage Defects in the Knee
- ClinicalTrials.gov ID
- NCT03873545
- Acronym / sponsor ID
- PRO-002
- Conditions
- Cartilage Injury, Cartilage Damage
- Keywords
- Cartilage, Cartilage Injury, Cartilage Repair, Cartilage Damage, Cartilage Lesion, Cartilage Defect
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (actual)
- Lead sponsor
- AlloSourceIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical study is to evaluate the use of ProChondrix Cryopreserved Osteochondral Allograft to obtain evidence of effectiveness, defined as an improvement in physical function and pain, when used on a symptomatic cartilage defect on the femoral condyle or patella in a mechanically stable knee.
Detailed description
This clinical study will use a multi-center, prospective design, to evaluate ProChondrix CR in approximately 80 patients who are scheduled to undergo treatment of a cartilage defect on the femoral condyle or patella.Patient follow-up will include a period of 60 months after surgery. During this follow-up period, each patient will be evaluated seven (7) times at: 3, 6, 12, 24, 36, 48 and 60 months after surgical intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryopreserved Osteochondral AllograftAlso: ProChondrix CRThis tissue is a laser-etched, cryopreserved fresh osteochondral allograft that was developed as a single-stage alternative for articular cartilage restoration. | Procedure or surgery | – |
Primary outcome
Subjective International Knee Documentation Committee (IKDC) Score
Time frame: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
Change in physical pain and function as assessed by IKDC score from baseline to 60 months post-surgery
3 secondary outcomes
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
SF-12 survey
Time frame: Baseline, 3, 6, 12, 24, 36, 48 and 60 months
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Scores
Time frame: 12, 24 and 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cartilage Injury and Cartilage Damage, run by AlloSource at 3 sites in United States.
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 6 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Subjective International Knee Documentation Committee (IKDC) Score (time frame: Baseline, 3, 6, 12, 24, 36, 48 and 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2025.