Long-term safety and performance evaluation of the Infinity-Lock Button System for shoulder joint stabilization

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the long-term safety and performance of the Infinity-Lock Button System (ILBS) in patients with acute and chronic dislocations of the acromioclavicular joint. The study will enroll 58 subjects who meet specific eligibility criteria and will receive the ILBS as part of a single-arm intervention. Data will be collected over a follow-up period of 3 years, with assessments at 3 months, 6 months, 1 year, 2 years, and 3 years post-implantation. The study is designed to verify the device's effectiveness as per the manufacturer's instructions.

Why it matters

Who can join: the full rules

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.

Where it's running

• East Kent Hospitals University NHS Foundation Trust,
  Canterbury, United Kingdom Recruiting
• Barts Health NHS Trust
  London, United Kingdom Recruiting
• Nottingham University Hospitals
  Nottingham, United Kingdom Recruiting
• Royal Berkshire NHS Foundation Trust
  Reading, United Kingdom Active not recruiting

Study contacts

• Study coordinator: Lisa Cook
• Email: lisa.cook@xiros.co.uk
• Phone: +44 (0) 113 238 7200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.