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.
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).
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.
Grade III-VI ACJ Dislocations.
Cohort
Prospective
Infinity-Lock Button System
DeviceInfinity-Lock Button System
Constant Murley Score (CMS)
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
device-related and/or procedure-related adverse events up to 1 year after surgery.
Constant Murley Score (CMS)
Change from baseline CMS and subscale scores (pain, activities of daily living, strength and ROM) at each timepoint up to 3 years after surgery. Minimum score is 0 maximum is 100 with the better functioning shoulders having a greater number of points.
American Shoulder and Elbow Surgeons Score (ASES)
Change from baseline American Shoulder and Elbow Surgeons (ASES) Score at each timepoint up to 3 years after surgery. Total score 0-100 ASES points, 0 = worse pain and functional loss/disability.
RAND Short Form 36 (SF-36) V1
Change from baseline RAND Short Form 36 (SF-36) V1 Quality of Life Health Survey at each timepoint up to 3 years after surgery.The RAND SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Nottingham Clavicle Score (NCS)
Change from baseline Nottingham Clavicle Score (NCS) at each timepoint up to 3 years after surgery. Maximum score of 100 (fewest difficulties) and a minimum score of 20 (most difficulties)
