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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorXiros Ltd

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Infinity-Lock Button System

Treatment groups

58 Participants
are divided into 1 treatment group

Sponsors and collaborators