The 12 month post-operative study is designed to provide safety and performance data on the Round XTENDOBUTTON fixation device after knee repair.
This is a retro-prospective 12 month follow-up study of the safety and performance of the Round XTENDOBUTTON fixation device post knee repair in Australian centres.
The Primary Objective is to assess successful fixation with the Round XTENDOBUTTON and the Secondary Objective is to generate safety and performance evidence for the Round XTENDOBUTTON Device via the collection of functional outcomes, patient reported outcomes and safety data.
Forty subjects will be enrolled; who have had the round XTENDOBUTTON Device implanted. To eliminate the potential for selection bias, Investigators will consecutively screen all subjects who have undergone knee/ligament repair/reconstruction using the Round XTENDOBUTTON Fixation Device. Subjects meeting the eligibility criteria will be contacted regarding interest in study participation. Screening will be conducted in sequential order based on the date of subjects' knee repair procedure; earliest to latest. Screening efforts must be documented on a screening and enrollment log, on which reasons for exclusion from or denial to participate should be noted A medical chart review will be conducted to identify potential study subjects who have been implanted with the ROUND XTENDOBUTTON device at the study site.
Visit 2 - 12 months post -op.
Safety will be evaluated by assessing the frequency and nature of adverse events, serious adverse events and revisions.
|Treatment||Round XTENDOBUTTON Fixation Device used in suture fixation of ligaments and tendons in conjunction with an ULTRABUTTON™ product or ENDOBUTTON™ device.|
|Clinical Study Identifier||NCT04211857|
|Sponsor||Smith & Nephew, Inc.|
|Last Modified on||29 November 2020|
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.Learn more
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.Learn more
Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.Learn more
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