Surgical Safety and Effectiveness in Orthopedics: Swiss-wide Multicenter Evaluation and Prediction of Core Outcomes in Arthroscopic Rotator Cuff Reconstruction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 973
- Locations
- 20
- Primary Endpoint
- Patient-reported change in shoulder functional outcome OSS
Study Overview
Brief Summary
Surgical safety and effectiveness in orthopedics: Swiss-wide multicenter evaluation and prediction of core outcomes in arthroscopic rotator cuff reconstruction.
Detailed Description
In this project prospective data are collected from a representative group of specialized clinics performing arthroscopic rotator cuff repair (ARCR) to serve as reference baseline and outcome values, as well as the development of prediction models for individual patients.
Ultrasound and MRI (on a subset of patients) examination will be performed at 12 months.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adult patients
- •diagnosed with a partial or full-thickness rotator cuff tear using magnetic resonance imaging (MRI)
- •planned primarily surgical partial or complete repair by arthroscopic procedure
- •able to understand the content of the patient information/ consent form and give consent to take part in the project
Exclusion Criteria
- •surgical procedure for irreparable tears, i.e. muscle transfer, acromio-humeral spacer or superior capsular reconstruction
- •revision surgery (prior repair of the rotator cuff in the same shoulder)
- •planned open or mini-open reconstructions
- •patients with a language barrier hindering questionnaire completion (either in German, French, Italian or English)
- •patients unlikely to attend clinical follow-up
- •pregnancy
- •legal incompetence
Outcomes
Primary Outcomes
Patient-reported change in shoulder functional outcome OSS
Time Frame: at Baseline and at 6 months after surgery.
The Oxford Shoulder Score (OSS) is a condition-specific questionnaire developed for patients with a degenerative or inflammatory state of the shoulder. It contains twelve items to be answered by the patient independently, which deal with pain (degree, time point) and possible handicaps in private and professional life. There are five categories of response for every question, corresponding to a score ranging from 0 to 4. Scores are combined to give a single score, with a range from 0 (worst outcome) to 48 (best outcome).
Change of shoulder stiffness
Time Frame: at Baseline and at 6 months after surgery.
this event was defined as a postoperative restriction in passive shoulder motion diagnosed within 6 months after ARCR in at least two of the motion planes of flexion, abduction and external rotation in 0° abduction. Motion restriction is to be assessed separately for each plane
Secondary Outcomes
- Constant Murley Score (CMS)(at 6 and 12 months)
- Shoulder strength (kg) in abduction at 6 and 12 months(at 6 and 12 months)
- Patient perceived shoulder functionality change, acceptability of own symptom state(at 6, 12 and 24 months)
- Adverse event (AE) assessment: AEs reported by clinicians and patients(6 months)
- Change in Patient-reported shoulder pain on a Numeric Rating Scale (NRS)(at 6, 12 months and 24 months)
- Nonrestorative sleep (NRS) to assess Patient-reported quality of sleep(at 6, 12 and 24 months)
- Local AEs (Adverse events) according to the ARCR Core Event Set (CES)(24 months)
- Return to work, change of working condition(at 6, 12 and 24 months)
- Change in Oxford Shoulder Score (OSS)(at 6, 12 months and 24 months)
- Adverse event (AE) assessment: Final independent surgeon and patient-rated assessment of AEs(6 months)
- Rotator cuff and biceps tendon integrity by MRI(at 12 months)
- Rotator cuff muscle fatty infiltration by MRI(at 12 months)
- Status of repair implants e.g. anchors by MRI(at 12 months)
- PROMIS Depression and Anxiety Short Formto assess level of depression and anxiety(at 6, 12 and 24 months)
- Subjective Shoulder Value (SSV)(at 6, 12 months and 24 months)
- Quality of life (utilities and general health): EQ-5D-5L(at 12 and 24 months)
- Adverse event (AE) assessment:Comprehensive Complication Index (CCI)(6 months)