ProChondrix® CR Articular Cartilage Restoration Evaluation (PACE) Registry

AlloSource48 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cartilage Injury Cartilage Damage

Interventions

Articular cartilage repairOTHER

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.

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (5)

University of Southern Alabama

Mobile, Alabama, United States

Rocky Mountain Foot and Ankle Center

Wheat Ridge, Colorado, United States

CAO Research Foundation

Washington D.C., District of Columbia, United States

University of Kentucky Research Foundation

Lexington, Kentucky, United States

Outcomes

Primary Outcomes

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.

Time frame: 10 Years Post-Operative

Data from ClinicalTrials.gov

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