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Not yet recruitingNCT07786207C-SHOREUpdated Sep 24, 2026

Knee Cartilage Repair Registry

An observational study in Knee Injuries and Joint Surface Knee Lesions, sponsored by Smith & Nephew, Inc.. Not yet recruiting at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Smith & Nephew, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

The registry will collect both prospective and retrospective/prospective data.

02

Conditions studied

  • Knee Injuries
  • Joint Surface Knee Lesions

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Keywords

  • Knee cartilage lesions
  • joint surface lesions of the knee
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants undergoing routine knee cartilage repair

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

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.
04

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
1,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • 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

  • DeviceMarketed Product - MP01

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

  • ProcedureOther Surgical Treatments

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

05

What researchers measure

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.

    Time frame: Baseline and 24 months

06

Study locations

6 sites
  • Orthopedic Centers of Colorado
    Parker, Colorado 80134, United States
  • CAO Research Foundation
    Washington D.C., District of Columbia 20036, United States
  • The Orthopaedic Research Foundation, Inc.
    Indianapolis, Indiana 46278, United States
  • Western Kentucky Heart and Lung Research Foundation
    Bowling Green, Kentucky 42101, United States
  • The Physician's Group, LLC
    Oklahoma City, Oklahoma 73114, United States
    • Elaine Justice · Contact · elaine@ojri.com
    • R. Garrett Steinmetz, MD · Principal investigator
  • Penn Highlands DuBois
    DuBois, Pennsylvania 15801, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07786207
Lead sponsor
Smith & Nephew, Inc.
Responsible party
Sponsor
First posted
Aug 25, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Mar 31, 2034 (estimated)
Completion
Mar 31, 2034 (estimated)
Last update
Sep 24, 2026

Study contacts

Judith Horner
Contact
Judith.Horner@smith-nephew.com
+44 (0)1482 673251
Laura Everson
Contact
Laura.Everson@smith-nephew.com
Nick DePhillipo, PhD, MBA, ATC
study chair · Smith & Nephew, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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