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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04301258
Other study ID # REG-PRO-002
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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