ProChondrix® CR Articular Cartilage Restoration Evaluation (PACE) Registry

AlloSource

Status: Terminated

Conditions: Cartilage Injury; Cartilage Damage

Treatments: Other: Articular cartilage repair

Study type: Observational

Funder types: Industry

Identifiers

NCT04301258

REG-PRO-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

48 participants in 4 patient groups

Articular Cartilage Defect of the Knee

Description:

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

Treatment:

Other: Articular cartilage repair

Articular Cartilage Defect of the Ankle

Description:

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

Treatment:

Other: Articular cartilage repair

Articular Cartilage Defect of the Foot

Description:

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

Treatment:

Other: Articular cartilage repair

Articular Cartilage Defect of the Hip

Description:

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

Treatment:

Other: Articular cartilage repair