Post-market Clinical Follow-up (PMCF) Study of the Infinity-Lock Button System for Acromioclavicular Joint Stabilisation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Infinity-Lock Button System.
- Who it may be relevant to
- Registry conditions: Acromioclavicular; Dislocation. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Post-market Clinical Follow-up (PMCF) Study of the Infinity-Lock™ Button System for Acromioclavicular Joint Stabilisation
Overview
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.
Interventions
- Device Infinity-Lock Button System
Infinity-Lock Button System
Primary outcome measures
- Constant Murley Score (CMS) [Time frame: 1 year]
- Device Related or Procedure Related Adverse events [Time frame: 1 year]
Secondary outcome measures (7)
- Constant Murley Score (CMS) [Time frame: 3 years]
- American Shoulder and Elbow Surgeons Score (ASES) [Time frame: 3 years]
- RAND Short Form 36 (SF-36) V1 [Time frame: 3 years]
- Nottingham Clavicle Score (NCS) [Time frame: 3 years]
- Ability to perform normal daily work and normal recreational activities [Time frame: 3 years]
- coracoclavicular distance [Time frame: 1 year]
- Device-related and/or procedure-related adverse events [Time frame: 3 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 4 centers
- East Kent Hospitals University NHS Foundation Trust, — Canterbury
- Barts Health NHS Trust — London
- Nottingham University Hospitals — Nottingham
- Royal Berkshire NHS Foundation Trust — Reading
Identifiers
NCT: NCT05397210 · CRE 019