Cartilage InjuryNCT04301258
ProChondrix® CR Articular Cartilage Restoration Evaluation (PACE) Registry
An observational study of Cartilage Injury and Cartilage Damage, run by AlloSource at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cartilage Injury, Cartilage Damage
- What is being tested?
- Articular cartilage repair
- How many people
- 48 participants
- Where
- 5 sitesUnited States
- Study dates
- 6 Jan 2020to 14 Sep 2023
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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;
Who cannot join
- Is a ward of the state, prisoner, or transient.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Beacon Orthopaedics & Sports Medicine
Cincinnati, Ohio, 45247
University of Kentucky Research Foundation
Lexington, Kentucky, 40506
University of Southern Alabama
Mobile, Alabama, 36604
CAO Research Foundation
Washington D.C., District of Columbia, 20037
Rocky Mountain Foot and Ankle Center
Wheat Ridge, Colorado, 80033
About this study
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.
Read the 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.
- Conditions
- Cartilage Injury, Cartilage Damage
- Being tested
- Articular cartilage repair
- Keywords
- Cartilage, Cartilage Injury, Cartilage Repair, Cartilage Damage, Cartilage Lesion, Cartilage Defect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Articular cartilage repairOther
Also called ProChondrix CR
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.
| Study group | Role | What they receive |
|---|---|---|
| Articular Cartilage Defect of the Knee | Patients, who undergo an articular cartilage repair of the knee using ProChondrix CR. Receives: Other: Articular cartilage repair | |
| Articular Cartilage Defect of the Ankle | Patients, who undergo an articular cartilage repair of the ankle using ProChondrix CR. Receives: Other: Articular cartilage repair | |
| Articular Cartilage Defect of the Foot | Patients, who undergo an articular cartilage repair of the foot using ProChondrix CR. Receives: Other: Articular cartilage repair | |
| Articular Cartilage Defect of the Hip | Patients, who undergo an articular cartilage repair of the hip using ProChondrix CR. Receives: Other: Articular cartilage repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 Years Post-Operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start6 Jan 2020
- Primary completion14 Sep 2023
- Study completion14 Sep 2023
Why it stopped: Duplicative data/insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 48 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- AlloSource
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301258
- Sponsor's protocol ID
- REG-PRO-002
- Status last verified
- Nov 2025
- First submitted
- 6 Mar 2020
- Last updated
- 21 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProChondrix® CR Articular Cartilage Restoration Evaluation (PACE) Registry
- ClinicalTrials.gov ID
- NCT04301258
- Acronym / sponsor ID
- REG-PRO-002
- Conditions
- Cartilage Injury, Cartilage Damage
- Keywords
- Cartilage, Cartilage Injury, Cartilage Repair, Cartilage Damage, Cartilage Lesion, Cartilage Defect
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Duplicative data/insufficient enrollment
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AlloSourceIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 14 Sep 2023 (actual)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Articular Cartilage Defect of the Knee | – | Other: Articular cartilage repairPatients, who undergo an articular cartilage repair of the knee using ProChondrix CR. |
| Articular Cartilage Defect of the Ankle | – | Other: Articular cartilage repairPatients, who undergo an articular cartilage repair of the ankle using ProChondrix CR. |
| Articular Cartilage Defect of the Foot | – | Other: Articular cartilage repairPatients, who undergo an articular cartilage repair of the foot using ProChondrix CR. |
| Articular Cartilage Defect of the Hip | – | Other: Articular cartilage repairPatients, who undergo an articular cartilage repair of the hip using ProChondrix CR. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (1 listed)
- Is a ward of the state, prisoner, or transient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Articular cartilage repairAlso: ProChondrix CRPatient 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 | Articular Cartilage Defect of the Ankle, Articular Cartilage Defect of the Foot, Articular Cartilage Defect of the Hip, Articular Cartilage Defect of the Knee |
Primary outcome
Long-Term Outcomes of ProChondrix CR
Time frame: 10 Years Post-Operative
Obtain long-term results on patients who have undergone an articular cartilage repair procedure using ProChondrix CR, as assessed by patient reported outcomes.
Results and safety
The study was stopped early (reason given: Duplicative data/insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cartilage Injury and Cartilage Damage, run by AlloSource at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Duplicative data/insufficient enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-Term Outcomes of ProChondrix CR (time frame: 10 Years Post-Operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.