RecruitingNCT05397210
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
Sponsor
Xiros Ltd
Enrollment
58 participants
Start Date
Sep 26, 2022
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 16 Years
Inclusion Criteria3
- 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 Criteria5
- 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.
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Interventions
DEVICEInfinity-Lock Button System
Infinity-Lock Button System
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT05397210