ProChondrix® CR Articular Cartilage Restoration Evaluation (PACE) Registry

Cartilage Injury Clinical Trial

Official title:

ProChondrix® CR Articular Cartilage Restoration Evaluation (PACE) Registry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04301258
• Other study ID #: REG-PRO-002
• Status: Terminated
• Start date: January 6, 2020
• Est. completion date: September 14, 2023

Study information

• Verified date: September 2023
• Source: AlloSource
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: September 14, 2023
• Est. primary completion date: September 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cartilage Damage
• Cartilage Injury

Intervention

Other:
• Articular cartilage repair
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.

Locations

Country	Name	City	State
United States	Beacon Orthopaedics & Sports Medicine	Cincinnati	Ohio
United States	University of Kentucky Research Foundation	Lexington	Kentucky
United States	University of Southern Alabama	Mobile	Alabama
United States	CAO Research Foundation	Washington	District of Columbia
United States	Rocky Mountain Foot and Ankle Center	Wheat Ridge	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
AlloSource

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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