ProChondrix® CR Articular Cartilage Restoration Evaluation (PACE) Registry

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.

Study Overview

• Status: Terminated
• Conditions: Cartilage Injury; Cartilage Damage
• Intervention / Treatment: Other: Articular cartilage repair

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 Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

• Study Contact: Name: Claire McFadyen; Phone Number: 720-484-2452; Email: cmcfadyen@allosource.org
• Study Contact Backup: Name: Elizabeth Esterl, DNP, MS, RN; Phone Number: 720-873-4700; Email: eesterl@allosource.org

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36604
      • University of Southern Alabama
  • Colorado
    • Wheat Ridge, Colorado, United States, 80033
      • Rocky Mountain Foot and Ankle Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • CAO Research Foundation
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University of Kentucky Research Foundation
  • Ohio
    • Cincinnati, Ohio, United States, 45247
      • Beacon Orthopaedics & Sports Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients, who diagnosed by their treating physician, have a cartilage defect in the knee, ankle, foot or hip that requires surgical intervention utilizing ProChondrix CR.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Articular Cartilage Defect of the Knee; Patients, who undergo an articular cartilage repair of the knee using ProChondrix CR.	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.; Other Names: ProChondrix CR
Articular Cartilage Defect of the Ankle; Patients, who undergo an articular cartilage repair of the ankle using ProChondrix CR.	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.; Other Names: ProChondrix CR
Articular Cartilage Defect of the Foot; Patients, who undergo an articular cartilage repair of the foot using ProChondrix CR.	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.; Other Names: ProChondrix CR
Articular Cartilage Defect of the Hip; Patients, who undergo an articular cartilage repair of the hip using ProChondrix CR.	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.; Other Names: ProChondrix CR

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AlloSource
• Investigators: Study Director: Elizabeth Esterl, DNP, MS, RN, AlloSource

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Actual): September 14, 2023
• Study Completion (Actual): September 14, 2023

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Cartilage Damage; Cartilage; Cartilage Repair; Cartilage Defect; Cartilage Injury; Cartilage Lesion
• Other Study ID Numbers: REG-PRO-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No