Knee cartilage repair registry data collection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational registry that gathers data from patients receiving knee cartilage repair procedures, including the marketed product MP01 and other surgical options. It combines prospective and retrospective data to reflect routine clinical practice. The goal is to understand how different surgical approaches perform in real-world settings and support future research on treatment outcomes for knee cartilage lesions. Data are entered into a centralized database to analyze patterns of care and effectiveness. Participation requires informed consent and completion of electronic outcomes assessments and questionnaires.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Prospective Subjects

* Provides written informed consent.
* Is eighteen (18) years of age or older at time of consent and considered skeletally mature in the opinion of the investigator.
* Scheduled to undergo knee cartilage surgery with the Marketed Product-MP01 OR other knee cartilage repair surgery.
* For subjects having other knee cartilage repair surgery:

  \- Falls within Marketed Product-MP01 on label indication: Knee chondral or osteochondral lesions (ICRS grade III and above, 1-7cm2) in patients with or without mild-moderate knee osteoarthritis (K/L 0-3).
* Has an electronic device and is willing and able to use the device to complete the 'Electronic Clinical Outcomes Assessment' (eCOA).
* Willing and able to complete all requested questionnaires.
* Able to follow instructions and deemed capable of completing registry protocol requirements.

Retrospective/Prospective Subjects

* Provides written informed consent.
* Was eighteen (18) years of age or older at time of surgery and considered skeletally mature at that time in the opinion of the investigator.
* Underwent knee cartilage repair surgery with the Marketed Product-MP01 within the last 2-years.
* Has an electronic device and is willing and able to use the device to complete the eCOA.
* Willing and able to complete all requested questionnaires.
* Able to follow instructions and deemed capable of completing registry protocol requirements.
* Consents to retrospective data being collected from pre-operative visit(s) and surgery through to the point of consent as available in their medical notes.

Exclusion Criteria:

* History of allergic reaction or intolerance of materials containing calcium carbonate or hyaluronate/coral derivatives.
* Is actively participating in a cartilage repair clinical trial.
* For subjects having other knee cartilage repair surgery:

  \- Treatment will be on patellar lesion(s).
* Has participated previously in this registry (with the index or contralateral knee).
* Meets the definition of a Vulnerable Subject per ISO 14155 Section 3.56.

Where it's running

• Orthopedic Centers of Colorado
  Parker, Colorado, United States Recruiting
• CAO Research Foundation
  Washington D.C., District of Columbia, United States Recruiting
• The Orthopaedic Research Foundation, Inc.
  Indianapolis, Indiana, United States Recruiting
• Penn Highlands DuBois
  DuBois, Pennsylvania, United States Recruiting
• Western Kentucky Heart and Lung Research Foundation
  Bowling Green, Kentucky, United States Not yet recruiting
• The Physician's Group, LLC
  Oklahoma City, Oklahoma, United States Not yet recruiting

Study contacts

• Study coordinator: Judith Horner
• Email: Judith.Horner@smith-nephew.com
• Phone: +44 (0)1482 673251

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.