An observational study in Acromioclavicular; Dislocation, sponsored by Xiros Ltd. Recruiting at 4 sites in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-01-27.
Sponsored by Xiros Ltd · Observational
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.
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.
98 studies on the registry are indexed under Joint Dislocations; 21 are open to participants now.
This study's planned enrollment of 58 is below the median of 100 across 37 observational studies indexed under Joint Dislocations.
Browse Joint Dislocations studies →Xiros Ltd is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Grade III-VI ACJ Dislocations.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient must be 16 years old or above.
Exclusion criteria.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: 1 year
Device Related or Procedure Related Adverse events
device-related and/or procedure-related adverse events up to 1 year after surgery.
Time frame: 1 year
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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 1 year
Device-related and/or procedure-related adverse events
Device-related and/or procedure-related adverse events up to 3 years after surgery.
Time frame: 3 years
Not enrolling at this site.
Plan to share: No — No plan to share IDP
No publications or documents are linked to this record.
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