Status:
RECRUITING
Post-market Clinical Follow-up (PMCF) Study of the Infinity-Lock Button System for Acromioclavicular Joint Stabilisation
Lead Sponsor:
Xiros Ltd
Conditions:
Acromioclavicular; Dislocation
Eligibility:
All Genders
16+ years
Brief 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 Acromi...
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 Acromi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patient must be 16 years old or above.
- Patient is diagnosed with acute or chronic Grade Ill-VI ACJ dislocation.
- Patient is willing to participate in the study and have been informed of the nature of the study, agree to its follow-up and have provided written informed consent as approved by the Research Ethics Committee (REC).
- Exclusion criteria.
- Known hypersensitivity to implant materials. If the patient is suspected of having any foreign body sensitivity, appropriate tests should be made prior to implantation.
- Infections or any other structural or pathological condition of the bone or soft tissue (such as hyperlaxity) that would be expected to impair healing or secure fixation.
- Patients unable or unwilling to restrict activities to prescribed levels or follow a rehabilitation programme during the healing period.
- Skeletally immature patients are not suited as the Infinity-Lock™ Button System will not elongate with growth. The use of this medical device and placement of hardware or implants must not bridge, disturb or disrupt the growth plate.
- Any other conditions or factors which in the opinion of the Investigator may interfere with study conduct.
Exclusion
Key Trial Info
Start Date :
September 26 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT05397210
Start Date
September 26 2022
End Date
December 1 2028
Last Update
September 16 2025
Active Locations (6)
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1
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, United Kingdom, LS9 7TF
2
East Kent Hospitals University NHS Foundation Trust,
Canterbury, United Kingdom
3
Hywel Dda University Local Health Board
Carmarthen, United Kingdom
4
Barts Health NHS Trust
London, United Kingdom, E1 1FR