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

Recruiting

• Conditions: Acromioclavicular; Dislocation
• Interventions: Device: Infinity-Lock Button System

• Registration Number: NCT05397210
• Lead Sponsor: Xiros Ltd

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.

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 Timeline

• Study First Submitted: 2022-05-24
• Study First Submitted QC: 2022-05-24
• Study First Posted: 2022-05-31
• Study Start: 2022-09-26
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Primary Completion: 2026-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 58

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infinity-Lock™ Button System	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.

Primary Outcome Measures

Name	Time	Method
Device Related or Procedure Related Adverse events	1 year	device-related and/or procedure-related adverse events up to 1 year after surgery.
Constant Murley Score (CMS)	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Device-related and/or procedure-related adverse events	3 years	Device-related and/or procedure-related adverse events up to 3 years after surgery.
Constant Murley Score (CMS)	3 years	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.
American Shoulder and Elbow Surgeons Score (ASES)	3 years	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.
RAND Short Form 36 (SF-36) V1	3 years	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.
Nottingham Clavicle Score (NCS)	3 years	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)
Ability to perform normal daily work and normal recreational activities	3 years	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
coracoclavicular distance	1 year	Change from baseline CC distance using the anteroposterior (AP) X-ray (Zanca view) at each timepoint up to 1 year after surgery.

Trial Locations

Locations (6)

Leeds Teaching Hospitals NHS Trust; 🇬🇧 Leeds, West Yorkshire, United Kingdom

East Kent Hospitals University NHS Foundation Trust,; 🇬🇧 Canterbury, United Kingdom

Hywel Dda University Local Health Board; 🇬🇧 Carmarthen, United Kingdom

Barts Health NHS Trust; 🇬🇧 London, United Kingdom

Nottingham University Hospitals; 🇬🇧 Nottingham, United Kingdom

Royal Berkshire NHS Foundation Trust; 🇬🇧 Reading, United Kingdom