Joint Surface Knee Lesions, Knee Injuries
Conditions
Keywords
Knee cartilage lesions, joint surface lesions of the knee
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.
Detailed description
The registry will collect both prospective and retrospective/prospective data.
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.
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score change from Baseline to 24-months | 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. |
Countries
United States
Contacts
CONTACTJudith Horner
CONTACTLaura Everson
STUDY_CHAIRNick DePhillipo, PhD, MBA, ATC
Smith & Nephew, Inc.
Outcome results
None listed