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

Xiros

Status: Enrolling

Conditions: Acromioclavicular; Dislocation

Treatments: Device: Infinity-Lock Button System

Study type: Observational

Funder types: Industry

Identifiers

NCT05397210

CRE 019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

58 participants in 1 patient group

Infinity-Lock™ Button System

Description:

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.

Treatment:

Device: Infinity-Lock Button System