ProChondrix® CR Articular Cartilage Restoration Evaluation (PACE) Registry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- AlloSource
- Enrollment
- 48
- Locations
- 5
- Primary Endpoint
- Long-Term Outcomes of ProChondrix CR
Study Overview
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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Long-Term Outcomes of ProChondrix CR
Time Frame: 10 Years Post-Operative
Obtain long-term results on patients who have undergone an articular cartilage repair procedure using ProChondrix CR, as assessed by patient reported outcomes.
Secondary Outcomes
No secondary outcomes reported