Prospective Evaluation of ProChondrix CR for Repair of Articular Cartilage Defects on Femoral Con… (NCT03873545) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Prospective Evaluation of ProChondrix CR for Repair of Articular Cartilage Defects on Femoral Condyle and Patella
United States34 participantsStarted 2019-03-18
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 malignan…
What they're measuring
1
Subjective International Knee Documentation Committee (IKDC) Score