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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acromioclavicular; Dislocation
• Intervention / Treatment: Device: Infinity-Lock Button System

Detailed Description

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.

The medical device (ILBS) in this study is already on the market and is manufactured by Xiros Ltd.

The ILBS comprises of a polyester flexible tubular tape and a titanium button. The tape is used to secure the joint and the button is used to secure the tape into position.

This study will collect data on patients who meet the entry criteria and receive the device; it will recruit patients from several clinical sites.

All patients in the study will receive the ILBS, as it is a single armed study. The total length of the study is expected to be 4.5 years; this includes a recruitment period of approximately 18 months and a 3-year follow-up.

A total of 58 subjects will be enrolled into the study. Follow up is at 3 months, 6 months, 1,2 and 3 years.

• Study Type: Observational
• Enrollment (Estimated): 58

Contacts and Locations

• Study Contact: Name: Vikki Adams; Phone Number: 07825626018; Email: vikki.adams@xiros.co.uk
• Study Contact Backup: Name: Lisa Cook; Phone Number: +44 (0) 113 238 7200; Email: lisa.cook@xiros.co.uk

Study Locations

• United Kingdom
  • Canterbury, United Kingdom
    • Recruiting
    • East Kent Hospitals University NHS Foundation Trust,
  • London, United Kingdom, E1 1FR
    • Recruiting
    • Barts Health NHS Trust
  • Nottingham, United Kingdom, NG7 2UH
    • Recruiting
    • Nottingham University Hospitals
  • Reading, United Kingdom, RG1 5AN
    • Active, not recruiting
    • Royal Berkshire NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Grade III-VI ACJ Dislocations.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Infinity-Lock Button System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant Murley Score (CMS)	Change from baseline CMS and subscale scores (pain, activities of daily living, strength and ROM) at each timepoint up to 3 years after surgery. Minimum score is 0 maximum is 100 with the better functioning shoulders having a greater number of points.	3 years
American Shoulder and Elbow Surgeons Score (ASES)	Change from baseline American Shoulder and Elbow Surgeons (ASES) Score at each timepoint up to 3 years after surgery. Total score 0-100 ASES points, 0 = worse pain and functional loss/disability.	3 years
RAND Short Form 36 (SF-36) V1	Change from baseline RAND Short Form 36 (SF-36) V1 Quality of Life Health Survey at each timepoint up to 3 years after surgery.The RAND SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.	3 years
Nottingham Clavicle Score (NCS)	Change from baseline Nottingham Clavicle Score (NCS) at each timepoint up to 3 years after surgery. Maximum score of 100 (fewest difficulties) and a minimum score of 20 (most difficulties)	3 years
Ability to perform normal daily work and normal recreational activities	This is a subscale of the CMS and is a measurement of how much of the normal daily work or recreational activity the patient is able to perform. The scale is a line which will be marked by the subject, it will be reported as 0-100% with 100% meaning they are able to perform 100% of their normal daily work or recreational activity	3 years
coracoclavicular distance	Change from baseline CC distance using the anteroposterior (AP) X-ray (Zanca view) at each timepoint up to 1 year after surgery.	1 year
Device-related and/or procedure-related adverse events	Device-related and/or procedure-related adverse events up to 3 years after surgery.	3 years

Collaborators and Investigators

• Sponsor: Xiros Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2022
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: May 24, 2022
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Wounds and Injuries; Joint Diseases; Joint Dislocations
• Other Study ID Numbers: CRE 019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IDP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No