PMCF Study of the Infinity-Lock™ Button System for ACJ Stabilisation
Research type
Research Study
Full title
Post-market Clinical Follow-up (PMCF) Study of the Infinity-Lock™ Button System for Acromioclavicular Joint Stabilisation
IRAS ID
310192
Contact name
Sam Vollans
Contact email
Sponsor organisation
Xiros Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 6 months, 2 days
Research summary
This is a Post-market Clinical Follow-up Study. It will verify the long-term safety and performance of the Infinity-Lock Button System (ILBS) when used for acute and chronic dislocations of the Acromioclavicular Joint and used as described by the manufacturer’s instructions.
The medical device (ILBS) in this study is already on the market and is manufactured by Xiros Ltd.
The ILBS comprises of a polyester flexible tubular tape and a titanium button. The tape is used to secure the joint and the button is used to secure the tape into position.
This study will collect data on patients who meet the entry criteria and receive the device; it will recruit patients from several clinical sites.
All patients in the study will receive the ILBS, as it is a single armed study.
The total length of the study is expected to be 4.5 years; this includes a recruitment period of approximately 18 months and a 3-year follow-up.
A total of 50 subjects will be enrolled into the study.
Follow up is at 3 months, 6 months, 1,2 and 3 years.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
22/EE/0053
Date of REC Opinion
13 Apr 2022
REC opinion
Further Information Favourable Opinion