Knee Cartilage Repair Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSmith & Nephew, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Has an electronic device and is willing and able to use the device to complete the 'Electronic Clinical Outcomes Assessment' (eCOA).
Disqualifiers
History of allergic reaction or intolerance of materials containing calcium carbonate or hyaluronate/coral derivatives.
Is actively participating in a cartilage repair clinical trial.
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 population
Participants undergoing routine knee cartilage repair
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Marketed Product - MP01
DeviceMarketed Product - MP01 is a medical device used in the treatment of knee-joint surface lesions.
Other Surgical Treatments
Procedure/SurgeryAny other surgical procedures used in the treatment of knee-joint surface lesions that fall within the Marketed Product - MP01 on label indication.
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Marketed Product - MP011 intervention
Group B: Other Knee Cartilage Procedures1 intervention
Trial outcomes
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov