NCT07786207

Brief Summary

This registry is designed to collect information on how different surgical procedures are used and how well they work in treating knee cartilage damage. Information will be collected from patients undergoing knee surgery for cartilage damage and entered into a large database that reflects routine clinical practice ("real-world" data). The data collected will be used to support future research and improve understanding of treatment outcomes for knee cartilage repair.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
91mo left

Started Sep 2026

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 30, 2026

Expected
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2034

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2034

Last Updated

August 25, 2026

Status Verified

June 1, 2026

Enrollment Period

7.5 years

First QC Date

August 21, 2026

Last Update Submit

August 21, 2026

Conditions

Keywords

Knee cartilage lesionsjoint surface lesions of the knee

Outcome Measures

Primary Outcomes (1)

  • International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score change from Baseline to 24-months

    The IKDC Subjective Knee Evaluation Form assesses the subject's opinion of their knee across 3 domains: symptoms (7 items), sports activity (2 items), and knee function (2 items; note: 'function prior to knee injury' is not included in the overall score). Responses vary for each item. The sum of all items is converted to a scale of 0 to 100, where 100 represents no limitation with activities \& absence of symptoms (i.e., the best outcome) and 0 represents the worst outcome.

    Baseline and 24 months

Study Arms (2)

Marketed Product - MP01

Participants who are having knee cartilage surgery with Marketed Product - MP01

Device: Marketed Product - MP01

Other Knee Cartilage Procedures

Participants who are having knee cartilage surgery with a procedure other than using Marketed Product - MP01

Procedure: Other Surgical Treatments

Interventions

Marketed Product - MP01 is a medical device used in the treatment of knee-joint surface lesions.

Marketed Product - MP01

Any other surgical procedures used in the treatment of knee-joint surface lesions that fall within the Marketed Product - MP01 on label indication.

Other Knee Cartilage Procedures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants undergoing routine knee cartilage repair

You may qualify if:

  • 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.
  • +2 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CAO Research Foundation

Washington D.C., District of Columbia, 20036, United States

Location

The Orthopaedic Research Foundation, Inc.

Indianapolis, Indiana, 46278, United States

Location

Oklahoma Sports Science and Orthopedics

Oklahoma City, Oklahoma, 73114, United States

Location

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Nick DePhillipo, PhD, MBA, ATC

    Smith & Nephew, Inc.

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2026

First Posted

August 25, 2026

Study Start (Estimated)

September 30, 2026

Primary Completion (Estimated)

March 31, 2034

Study Completion (Estimated)

March 31, 2034

Last Updated

August 25, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations