Acromioclavicular; DislocationNCT05397210
Post-market Clinical Follow-up (PMCF) Study of the Infinity-Lock Button System for Acromioclavicular Joint Stabilisation
An observational study of Acromioclavicular; Dislocation, run by Xiros Ltd at 4 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acromioclavicular; Dislocation
- What is being tested?
- Infinity-Lock Button System
- Type of treatment
- Medical device
- How many people
- 58 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 26 Sep 2022to Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Grade III-VI ACJ Dislocations.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom4 sites, 3 recruiting
- Recruiting
East Kent Hospitals University NHS Foundation Trust,
Canterbury
- Recruiting
Barts Health NHS Trust
London, E1 1FR
- Recruiting
Nottingham University Hospitals
Nottingham, NG7 2UH
- Active, not recruiting
Royal Berkshire NHS Foundation Trust
Reading, RG1 5AN
About this study
Official title: 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.
Read the 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.
- Conditions
- Acromioclavicular; Dislocation
- Being tested
- Infinity-Lock Button System
- Medical subject headings
- Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infinity-Lock Button SystemDevice
Infinity-Lock Button System
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Infinity-Lock Button System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Device Related or Procedure Related Adverse events
device-related and/or procedure-related adverse events up to 1 year after surgery.
Measured: 1 year
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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.
Measured: 1 year
Device-related and/or procedure-related adverse events
Device-related and/or procedure-related adverse events up to 3 years after surgery.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start26 Sep 2022
- Primary completionJan 2028 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acromioclavicular; DislocationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiros Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397210
- Sponsor's protocol ID
- CRE 019
- Status last verified
- Nov 2025
- First submitted
- 24 May 2022
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share IDP
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Clinical Follow-up (PMCF) Study of the Infinity-Lock™ Button System for Acromioclavicular Joint Stabilisation
- ClinicalTrials.gov ID
- NCT05397210
- Acronym / sponsor ID
- CRE 019
- Conditions
- Acromioclavicular; Dislocation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Xiros LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infinity-Lock™ Button System | – | Device: Infinity-Lock Button SystemParticipants 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Grade III-VI ACJ Dislocations.
Key inclusion criteria (3 listed)
- Patient must be 16 years old or above.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infinity-Lock Button SystemInfinity-Lock Button System | Device | Infinity-Lock™ Button System |
Primary outcome
Constant Murley Score (CMS)
Time frame: 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.
Device Related or Procedure Related Adverse events
Time frame: 1 year
device-related and/or procedure-related adverse events up to 1 year after surgery.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No. No plan to share IDP
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acromioclavicular; Dislocation, run by Xiros Ltd at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Cook (+44 (0) 113 238 7200, lisa.cook@xiros.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant Murley Score (CMS) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.