NCT05397210 Post-market Clinical Follow-up (PMCF) Study of the Infinity-Lock Button System for Acromioclavicular Joint Stabilisation
| NCT ID | NCT05397210 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xiros Ltd |
| Condition | Acromioclavicular; Dislocation |
| Study Type | OBSERVATIONAL |
| Enrollment | 58 participants |
| Start Date | 2022-09-26 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 58 participants in total. It began in 2022-09-26 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 Acromioclavicular Joint and used as described by the manufacturer's instructions.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05397210 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Acromioclavicular; Dislocation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05397210 currently recruiting?
Yes, NCT05397210 is actively recruiting participants. Contact the research team at lisa.cook@xiros.co.uk for enrollment information.
Where is the NCT05397210 trial being conducted?
This trial is being conducted at Canterbury, United Kingdom, London, United Kingdom, Nottingham, United Kingdom, Reading, United Kingdom.
Who is sponsoring the NCT05397210 clinical trial?
NCT05397210 is sponsored by Xiros Ltd. The trial plans to enroll 58 participants.