Infinity-Lock Button System: Infinity-Lock Button System
Study 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.
Eligibility
Sex
ALL
Min age
16 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)
Constant Murley Score (CMS) — 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 — 1 year device-related and/or procedure-related adverse events up to 1 year after surgery.
Trial sites (4)
Facility
City
Region
Status
East Kent Hospitals University NHS Foundation Trust,
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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