ProChondrix® CR Articular Cartilage Restoration Evaluation (PACE) Registry

NCT ID: NCT04301258

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-06

Study Completion Date

2023-09-14

Brief Summary

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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

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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.

Conditions

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Cartilage Injury Cartilage Damage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Articular Cartilage Defect of the Knee

Patients, who undergo an articular cartilage repair of the knee using ProChondrix CR.

Articular cartilage repair

Intervention Type OTHER

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.

Articular Cartilage Defect of the Ankle

Patients, who undergo an articular cartilage repair of the ankle using ProChondrix CR.

Articular cartilage repair

Intervention Type OTHER

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.

Articular Cartilage Defect of the Foot

Patients, who undergo an articular cartilage repair of the foot using ProChondrix CR.

Articular cartilage repair

Intervention Type OTHER

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.

Articular Cartilage Defect of the Hip

Patients, who undergo an articular cartilage repair of the hip using ProChondrix CR.

Articular cartilage repair

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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ProChondrix CR

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AlloSource

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Southern Alabama

Mobile, Alabama, United States

Site Status

Rocky Mountain Foot and Ankle Center

Wheat Ridge, Colorado, United States

Site Status

CAO Research Foundation

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

Site Status

University of Kentucky Research Foundation

Lexington, Kentucky, United States

Site Status

Beacon Orthopaedics & Sports Medicine

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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REG-PRO-002

Identifier Type: -

Identifier Source: org_study_id

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