Long-term safety and performance evaluation of the Infinity-Lock Button System for shoulder joint stabilization
Post-market Clinical Follow-up (PMCF) Study of the Infinity-Lock™ Button System for Acromioclavicular Joint Stabilisation
This study is testing the long-term safety and effectiveness of a new device called the Infinity-Lock Button System for people with shoulder joint dislocations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 58 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Xiros Ltd Industry-sponsored |
| Locations | 4 sites (Canterbury and 3 other locations) |
| Trial ID | NCT05397210 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 16 years and older diagnosed with acute or chronic Grade III-VI acromioclavicular joint dislocations.
Not a fit: Patients with known hypersensitivity to implant materials or those with infections or conditions that impair healing will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of the Infinity-Lock Button System for patients with acromioclavicular joint dislocations.
How similar studies have performed: While this study focuses on a specific device already on the market, similar studies evaluating post-market performance of medical devices have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Canterbury and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.