Clinical trial NCT05397210: Post-market Clinical Follow-up (PMCF) Study of the Infinity-Lock Button System for Acromioclavicular Joint Stabilisation
Official title: Post-market Clinical Follow-up (PMCF) Study of the Infinity-Lock™ Button System for Acromioclavicular Joint Stabilisation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acromioclavicular; Dislocation
Lead sponsor: Xiros Ltd
Sponsor class: INDUSTRY
First posted: 2022-05-31
Enrollment: 58
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Grade III-VI ACJ Dislocations.

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.

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.

Primary outcomes:
measure: Constant Murley Score (CMS)
timeFrame: 1 year
measure: Device Related or Procedure Related Adverse events
timeFrame: 1 year
Secondary outcomes:
measure: Constant Murley Score (CMS)
timeFrame: 3 years
measure: American Shoulder and Elbow Surgeons Score (ASES)
timeFrame: 3 years
measure: RAND Short Form 36 (SF-36) V1
timeFrame: 3 years
measure: Nottingham Clavicle Score (NCS)
timeFrame: 3 years
measure: Ability to perform normal daily work and normal recreational activities
timeFrame: 3 years
measure: coracoclavicular distance
timeFrame: 1 year
measure: Device-related and/or procedure-related adverse events
timeFrame: 3 years
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
state: West Yorkshire
city: Canterbury
country: United Kingdom
facility: East Kent Hospitals University NHS Foundation Trust,
city: Carmarthen
country: United Kingdom
facility: Hywel Dda University Local Health Board
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals
city: Reading
country: United Kingdom
facility: Royal Berkshire NHS Foundation Trust
Study officials:
References: