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

NCT05397210 | Recruiting FDA Device

• 1 other identifier: CRE 019
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 4

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.

Conditions

Acromioclavicular; Dislocation

Outcome Measures

Primary Outcomes (2)

• Constant Murley Score (CMS)

  The primary performance endpoint is the change in the CMS from baseline to 1 year after surgery. Minimum score is 0 maximum is 100 with the better functioning shoulders having a greater number of points.

  1 year

• Device Related or Procedure Related Adverse events

  device-related and/or procedure-related adverse events up to 1 year after surgery.

  1 year

Secondary Outcomes (7)

• Constant Murley Score (CMS)

  3 years

• American Shoulder and Elbow Surgeons Score (ASES)

  3 years

• RAND Short Form 36 (SF-36) V1

  3 years

• Nottingham Clavicle Score (NCS)

  3 years

• Ability to perform normal daily work and normal recreational activities

  3 years

Study Arms (1)

Infinity-Lock™ Button System

Participants diagnosed with acute or chronic Grade Ill-VI ACJ dislocation who require treatment with an Infinity-Lock Button System who meet the inclusion criteria and none of the exclusion criteria.

Device: Infinity-Lock Button System

Interventions

Infinity-Lock Button System DEVICE

Infinity-Lock Button System

Infinity-Lock™ Button System

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Grade III-VI ACJ Dislocations.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiros Ltd: lead

Study Sites (4)

East Kent Hospitals University NHS Foundation Trust,

Canterbury, United Kingdom

RECRUITING

Barts Health NHS Trust

London, E1 1FR, United Kingdom

RECRUITING

Nottingham University Hospitals

Nottingham, NG7 2UH, United Kingdom

RECRUITING

Royal Berkshire NHS Foundation Trust

Reading, RG1 5AN, United Kingdom

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Joint Dislocations

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries

Central Study Contacts

Lisa Cook

CONTACT

+44 (0) 113 238 7200; lisa.cook@xiros.co.uk

Vikki Adams

CONTACT

07825626018; vikki.adams@xiros.co.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: May 31, 2022
• Study Start: September 26, 2022
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2030
• Last Updated: January 27, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)