This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients who are undergoing rotator cuff repair using the REGENETEN◊ Bioinductive Implant System. The Registry will include up to 50 centers in the United Kingdom (UK), Europe, Australia, and up to 400 patients for the initial evaluation. Patients will be treated and evaluated according to standard medical care. Outcome data is collected up to 2 years post-surgery.
Study Type
OBSERVATIONAL
Enrollment
400
Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue.
Melbourne Orthopaedic Group
Windsor, Victoria, Australia
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Score
The descriptive system is used to describe the subject's health state \& consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems, and extreme problems. The subject is asked to indicate his/her health state by marking the most appropriate statement in each of the five areas. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. For instance, 'slight problems' (e.g. 'I have slight problems in walking about') is always coded as '2'. The digits for the 5 dimensions are combined in a 5-digit code. The EQ- 5D-5L index value is derived by using the vendor supplied calculator to convert each 5-digit EQ-5D-5L profile. A higher number is a better outcome.
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Quick DASH (Disabilities of Arm, Shoulder and Hand) Score
Quick DASH (Disabilities of Arm, Shoulder and Hand) is designed to measure physical function and symptoms. It assesses 11 items, with scores ranging from 0 to 100 where 0 indicates no disability (i.e., better outcome) and 100 indicates most severe disability (i.e., worse outcome).
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Oxford Shoulder Score (OSS)
The Oxford Shoulder Score (OSS) is a questionnaire for the assessment of outcomes of shoulder surgery, which can reduce the observer's errors in the evaluation. It contains 12- item patient-reported outcome (PRO) measures specifically designed and developed for assessing outcomes of shoulder surgery such as assessing the impact on patients' quality of life of degenerative conditions (e.g., arthritis and rotator cuff problems). The OSS consists of 12 questions each scored 0 to 4 (0=unbearable, 1=severe, 2=moderate, 3=mild, 4=none) with 4 representing the best outcome. When the 12 items are summed, this produces overall scores that run from 0 to 48, with zero (0) representing a severe shoulder problem and 48 representing no related problem. Higher scores represent better clinical outcomes.
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
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Schoen Klinik Lorsch
Lorsch, Rhine, Germany
RECRUITINGSchoen Klinik Dusseldorf
Düsseldorf, Germany
RECRUITINGMalteser Waldkrankenhaus Erlangen
Erlangen, Germany
RECRUITINGSporthopaedie Heidelberg
Heidelberg, Germany
RECRUITINGSt. Anna Hospital
Herne, Germany
RECRUITINGArtemed Klinikum München Süd
München, Germany
RECRUITINGOrthoMedicum Mittelhessen
Stadtallendorf, Germany
RECRUITINGRegional General Hospital F. Miulli
Acquaviva delle Fonti, Apulia, Italy
RECRUITINGOspedale Israelitico
Roma, Italy
RECRUITING...and 12 more locations
Pain, Visual Analog Scale (VAS) Score
Pain is assessed on a 100-point scale ranging from 0 to 100, with zero (0) representing no pain and 100 representing the worst pain imaginable
Time frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months
Single Assessment Numeric Evaluation (SANE) Score
The Single Assessment Numeric Evaluation (SANE) is a simple but effective measure where patients rate their shoulder condition as a percentage (0-100%), where 100% being completely normal and 0% being the worst condition imaginable.
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Retear Rate
Cumulative 3 months, 6 months, 12 months, and 24 months retear rate. Failure is defined as Sugaya Type IV or V retear/recurrence (full-thickness discontinuity seen on both coronal and oblique sagittal MRI images).
Time frame: 3 months, 6 months, 12 months, and 24 months
Post-operative Recovery: Sling Type and Mobilization Time
The type of sling will be collected and presented for each treatment arm summarizing if standard sling, shoulder immobilizer, abduction sling, ER sling, or other were advised. Mobilization time will be calculated for both arms.
Time frame: 2 weeks
Post-operative Recovery: Return to Work
Return to work questionnaires are collected at baseline and at 6 months post-op. At baseline, information on working arrangements are established: * Occupation status: Full time/part time/ retired * Occupation type: Sedentary/labor intensive * Impact of their diagnosis on their work performance: negative impact/no change At 6 months, information on changes to working arrangements is established: * Changes to occupation status * Returned to work and at what level: not returned due to procedure, not returned for other reasons, retired, lower level, same level, higher level * Time taken to return to work in days/weeks/months (if applicable)
Time frame: Baseline and 6 months