ProChondrix® CR

ProChondrix® CR Articular Cartilage Restoration Evaluation (PACE) Registry

Primary Sponsor: ALLOSOURCE

Principal Investigator: Scott Faucett, MD, MS

Brief Summary: 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.

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Condition or disease - Cartilage Injury;Cartilage Damage

Intervention/treatment - Other: Articular cartilage repair

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Detailed Description: 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.

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Study Design:

Study Type  - Observational [Patient Registry]
Estimated Enrollment - 500 participants
Observational Model - Cohort
Time Perspective - Other
Target Follow-Up Duration - 10 Years
Official Title - ProChondrix® CR Articular Cartilage Restoration Evaluation (PACE) Registry
Actual Study Start Date - January 6, 2020
Estimated Primary Completion Date - December 2040
Estimated Study Completion Date - December 2040