ProChondrix® CR Articular Cartilage Restoration Evaluation (PACE) Registry

Study Overview
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Brief Summary
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The primary objective of this registry is to obtain long-term outcomes on ProChondrix CR in cartilage repair procedures of the knee, ankle, foot and hip.

Detailed Description
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This multi-center, observational registry will be used to evaluate the effectiveness of ProChondrix CR in patients who undergo treatment for an articular cartilage defect in the knee, ankle, foot or hip. This registry will be performed at up to 30 clinical sites across the United States. Patient follow-up will occur following an articular cartilage repair procedure in which the patient receives ProChondrix CR. During this follow-up period, each patient will be evaluated at least four (4) times at: 3, 6, 12 and 24 months after surgical intervention and will continue annually for as long as patients are willing to fill out questionnaires and outcomes assessments up to 10 years post operatively.

Official Title
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ProChondrix® CR Articular Cartilage Restoration Evaluation (PACE) Registry

Conditions
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Cartilage Injury, Cartilage Damage

Intervention / Treatment
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* Other: Articular cartilage repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed by physician to have a cartilage defect in the knee, ankle, foot or hip that requires surgical intervention; Will be having, or has had, a cartilage repair procedure using ProChondrix CR; Has the ability to understand the requirements of the registry, to provide written informed consent and to comply with the registry protocol; Exclusion Criteria: • Is a ward of the state, prisoner, or transient.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Articular Cartilage Defect of the Knee<br>Patients, who undergo an articular cartilage repair of the knee using ProChondrix CR. | Other: Articular cartilage repair<br>* Patient reported outcomes will be collected on patients who have had a cartilage repair procedure using ProChondrix CR in the knee, hip, foot or ankle.<br>* Other names: ProChondrix CR;|
| Articular Cartilage Defect of the Ankle<br>Patients, who undergo an articular cartilage repair of the ankle using ProChondrix CR. | Other: Articular cartilage repair<br>* Patient reported outcomes will be collected on patients who have had a cartilage repair procedure using ProChondrix CR in the knee, hip, foot or ankle.<br>* Other names: ProChondrix CR;|
| Articular Cartilage Defect of the Foot<br>Patients, who undergo an articular cartilage repair of the foot using ProChondrix CR. | Other: Articular cartilage repair<br>* Patient reported outcomes will be collected on patients who have had a cartilage repair procedure using ProChondrix CR in the knee, hip, foot or ankle.<br>* Other names: ProChondrix CR;|
| Articular Cartilage Defect of the Hip<br>Patients, who undergo an articular cartilage repair of the hip using ProChondrix CR. | Other: Articular cartilage repair<br>* Patient reported outcomes will be collected on patients who have had a cartilage repair procedure using ProChondrix CR in the knee, hip, foot or ankle.<br>* Other names: ProChondrix CR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-Term Outcomes of ProChondrix CR | Obtain long-term results on patients who have undergone an articular cartilage repair procedure using ProChondrix CR, as assessed by patient reported outcomes. | 10 Years Post-Operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cartilage, Cartilage Injury, Cartilage Repair, Cartilage Damage, Cartilage Lesion, Cartilage Defect