NCT05397210

Post-market Clinical Follow-up (PMCF) Study of the Infinity-Lock Button System for Acromioclavicular Joint Stabilisation

Post-market Clinical Follow-up (PMCF) Study of the Infinity-Lock™ Button System for Acromioclavicular Joint Stabilisation

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 58 (estimated)
• Sponsor: Xiros Ltd · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 58 subjects will be enrolled into the study. Follow up is at 3 months, 6 months, 1,2 and 3 years.

Conditions

• Acromioclavicular; Dislocation

Interventions

Type	Name	Description
DEVICE	Infinity-Lock Button System	Infinity-Lock Button System

Timeline

• Start date: 2022-09-26
• Primary completion: 2028-01-01
• Completion: 2030-01-01
• First posted: 2022-05-31
• Last updated: 2026-01-27

Locations

4 sites across 1 country: United Kingdom

Regulatory

• FDA-regulated device study