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

Recruitingn/aAges 16 Years - anyAllXiros Ltd
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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-Lockโ„ข 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.
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What it tests

  • Infinity-Lock Button System
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Where

4 sites
East Kent Hospitals University NHS Foundation Trust,
Canterbury, United Kingdom
Barts Health NHS Trust
London, United Kingdom
Nottingham University Hospitals
Nottingham, United Kingdom
Royal Berkshire NHS Foundation Trust
Reading, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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