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

Launched by XIROS LTD · May 24, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the long-term safety and effectiveness of a medical device called the Infinity-Lock Button System (ILBS), which is used to stabilize the acromioclavicular joint, commonly known as the AC joint, after dislocations. The ILBS consists of a flexible tape and a titanium button that work together to secure the joint. The study aims to gather information on how well this device performs over time in patients who have either acute (recent) or chronic (long-term) dislocations of the AC joint.

To participate in this study, individuals must be at least 16 years old and diagnosed with a specific type of AC joint dislocation. Participants will receive the ILBS device and will be followed for up to three years after the procedure, with check-ins at 3, 6, 12, 24, and 36 months to monitor their recovery. This research is important as it will help ensure that the ILBS continues to be a safe and effective option for patients with this condition.

Gender

ALL

Eligibility criteria

• 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.