Knee InjuriesC-SHORENCT07786207
Knee Cartilage Repair Registry
An observational study of Knee Injuries and Joint Surface Knee Lesions, run by Smith & Nephew, Inc. at 6 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Injuries, Joint Surface Knee Lesions
- What is being tested?
- Marketed Product - MP01 and Other Surgical Treatments
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 1,000 participants
- Where
- 6 sitesUnited States
- Study dates
- 23 Sep 2026to 31 Mar 2034
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants undergoing routine knee cartilage repair
Who may be able to join
- 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).
Show all 17Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Laura Everson contact
6 sites in 1 country
United States6 sites, 6 recruiting
- Not yet recruiting
Western Kentucky Heart and Lung Research Foundation
Bowling Green, Kentucky, 42101
Chris Brice, BricCD@MCHealth.net
Chaitu Malempati, MD
- Recruiting
Penn Highlands DuBois
DuBois, Pennsylvania, 15801
Jared Ham, JSHam@phhealthcare.org
Matthew Valacallo, MD
- Recruiting
The Orthopaedic Research Foundation, Inc.
Indianapolis, Indiana, 46278
Melanie Glover, mglover@orthoindy.com
Corey Kendall, MD
- Not yet recruiting
The Physician's Group, LLC
Oklahoma City, Oklahoma, 73114
Elaine Justice, elaine@ojri.com
R. Garrett Steinmetz, MD
- Recruiting
Orthopedic Centers of Colorado
Parker, Colorado, 80134
Abby Watkins, abby.watkins@occ-ortho.com
Justin Newman, MD
- Recruiting
CAO Research Foundation
Washington D.C., District of Columbia, 20036
Stacy Tam, stacy.tam@caoresearch.org
Scott Faucett, MD, MS
About this study
Official title: Cartilage Repair Study of Health Outcomes and Real-world Evidence (C-SHORE)
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.
- Conditions
- Knee Injuries, Joint Surface Knee Lesions
- Being tested
- Marketed Product - MP01, Other Surgical Treatments
- Keywords
- Knee cartilage lesions, joint surface lesions of the knee
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marketed Product - MP01Device
Marketed Product - MP01 is a medical device used in the treatment of knee-joint surface lesions.
Other Surgical TreatmentsProcedure or surgery
Any other surgical procedures used in the treatment of knee-joint surface lesions that fall within the Marketed Product - MP01 on label indication.
| Study group | Role | What they receive |
|---|---|---|
| Marketed Product - MP01 | Participants who are having knee cartilage surgery with Marketed Product - MP01 Receives: Device: Marketed Product - MP01 | |
| Other Knee Cartilage Procedures | Participants who are having knee cartilage surgery with a procedure other than using Marketed Product - MP01 Receives: Procedure: Other Surgical Treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start23 Sep 2026
- Primary completion31 Mar 2034 (estimated)
- Study completion31 Mar 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies 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
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nick DePhillipo, PhD, MBA, ATC, Study chair, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786207
- Sponsor's protocol ID
- SNIS-S-1357
- Acronym
- C-SHORE
- Status last verified
- Jun 2026
- First submitted
- 21 Aug 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cartilage Repair Study of Health Outcomes and Real-world Evidence (C-SHORE)
- ClinicalTrials.gov ID
- NCT07786207
- Acronym / sponsor ID
- C-SHORE / SNIS-S-1357
- Conditions
- Knee Injuries, Joint Surface Knee Lesions
- Keywords
- Knee cartilage lesions, joint surface lesions of the knee
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2026 (actual)
- Primary completion
- 31 Mar 2034 (estimated)
- Study completion
- 31 Mar 2034 (estimated)
- First posted
- 25 Aug 2026 (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.
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.
Detailed description
The registry will collect both prospective and retrospective/prospective data.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Marketed Product - MP01 | – | Device: Marketed Product - MP01Participants who are having knee cartilage surgery with Marketed Product - MP01 |
| Other Knee Cartilage Procedures | – | Procedure: Other Surgical TreatmentsParticipants who are having knee cartilage surgery with a procedure other than using Marketed Product - MP01 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants undergoing routine knee cartilage repair
Key inclusion criteria (17 listed)
- 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:
Key exclusion criteria (6 listed)
- 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:
- 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.
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 |
|---|---|---|
| Marketed Product - MP01Marketed Product - MP01 is a medical device used in the treatment of knee-joint surface lesions. | Device | Marketed Product - MP01 |
| Other Surgical TreatmentsAny other surgical procedures used in the treatment of knee-joint surface lesions that fall within the Marketed Product - MP01 on label indication. | Procedure or surgery | Other Knee Cartilage Procedures |
Primary outcome
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score change from Baseline to 24-months
Time frame: Baseline and 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- 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.
Laura Everson contact
Nick DePhillipo, PhD, MBA, ATC study chair
Smith & Nephew, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Injuries and Joint Surface Knee Lesions, run by Smith & Nephew, Inc. at 6 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 17 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Judith Horner (+44 (0)1482 673251, Judith.Horner@smith-nephew.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score change from Baseline to 24-months (time frame: Baseline and 24 months). 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 8 Oct 2026.