Clinical trial NCT04321005: Surgical Safety and Effectiveness in Orthopedics: Swiss-wide Multicenter Evaluation and Prediction of Core Outcomes in Arthroscopic Rotator Cuff Reconstruction
Official title: Surgical Safety and Effectiveness in Orthopedics: Swiss-wide Multicenter Evaluation and Prediction of Core Outcomes in Arthroscopic Rotator Cuff Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tear
Keywords: Oxford Shoulder Score (OSS)
shoulder stiffness
arthroscopic rotator cuff repair
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: Swiss Orthopaedics
name: Schweizerische Versicherungsanstalt (SUVA)
First posted: 2020-03-25
Enrollment: 973
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated for a partial or full-thickness rotator cuff tear with primarily surgical partial or complete repair by arthroscopic procedure

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient-reported change in shoulder functional outcome OSS
timeFrame: at Baseline and at 6 months after surgery.
measure: Change of shoulder stiffness
timeFrame: at Baseline and at 6 months after surgery.
Secondary outcomes:
measure: Local AEs (Adverse events) according to the ARCR Core Event Set (CES)
timeFrame: 24 months
measure: Constant Murley Score (CMS)
timeFrame: at 6 and 12 months
measure: Shoulder strength (kg) in abduction at 6 and 12 months
timeFrame: at 6 and 12 months
measure: Change in Patient-reported shoulder pain on a Numeric Rating Scale (NRS)
timeFrame: at 6, 12 months and 24 months
measure: Change in Oxford Shoulder Score (OSS)
timeFrame: at 6, 12 months and 24 months
measure: Subjective Shoulder Value (SSV)
timeFrame: at 6, 12 months and 24 months
measure: Nonrestorative sleep (NRS) to assess Patient-reported quality of sleep
timeFrame: at 6, 12 and 24 months
measure: Return to work, change of working condition
timeFrame: at 6, 12 and 24 months
measure: PROMIS Depression and Anxiety Short Formto assess level of depression and anxiety
timeFrame: at 6, 12 and 24 months
measure: Patient perceived shoulder functionality change, acceptability of own symptom state
timeFrame: at 6, 12 and 24 months
measure: Quality of life (utilities and general health): EQ-5D-5L
timeFrame: at 12 and 24 months
measure: Adverse event (AE) assessment: AEs reported by clinicians and patients
timeFrame: 6 months
measure: Adverse event (AE) assessment: Final independent surgeon and patient-rated assessment of AEs
timeFrame: 6 months
measure: Adverse event (AE) assessment:Comprehensive Complication Index (CCI)
timeFrame: 6 months
measure: Rotator cuff and biceps tendon integrity by MRI
timeFrame: at 12 months
measure: Rotator cuff muscle fatty infiltration by MRI
timeFrame: at 12 months
measure: Status of repair implants e.g. anchors by MRI
timeFrame: at 12 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department for Shoulder and Elbow surgery Center for Musculoskeletal Surgery Campus Virchow
city: Baden
country: Switzerland
facility: Kantonsspital Baden AG,
state: Aarau
city: Binningen
country: Switzerland
facility: Kantonsspital Baselland
state: Baselland
city: Münchenstein
country: Switzerland
facility: Hirslanden Klinik Birshof
state: Baselland
city: St Moritz
country: Switzerland
facility: Klinik Gut
state: Graubünden
city: St. Gallen
country: Switzerland
facility: Klinik tür Orthopädische Chirurgie und Traumatologie des Bewegungsapparates Kantonsspital St. Gallen
state: Saint Gallen
city: Martigny
country: Switzerland
facility: Hopital du Valois (RSV)
state: Valais
city: Wallisellen
country: Switzerland
facility: Zentrum für Orthopädie & Neurochirurgie In-Motion
state: Zürich
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Basel
country: Switzerland
facility: ARTHRO Medics AG
city: Bern
country: Switzerland
facility: Sonnenhof
city: Bern
country: Switzerland
facility: Inselspital
city: Genève
country: Switzerland
facility: Hirslanden Clinique de Colline
city: Genève
country: Switzerland
facility: University Hospital Geneva
city: Lugano
country: Switzerland
facility: Regional Hospital Lugano
city: Solothurn
country: Switzerland
facility: Bürgerspital Solothurn, Klinik für Orthopädie und Traumatologie
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur, Klinik für Orthopädie und Traumatologie
city: Zürich
country: Switzerland
facility: Schulthess Klinik
city: Zürich
country: Switzerland
facility: Universitätsklinik Balgrist
city: Zürich
country: Switzerland
facility: Endoclinic
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Andreas Müller, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Audige L, Bucher HCC, Aghlmandi S, Stojanov T, Schwappach D, Hunziker S, Candrian C, Cunningham G, Durchholz H, Eid K, Flury M, Jost B, Ladermann A, Moor BK, Moroder P, Rosso C, Schar M, Scheibel M, Spormann C, Suter T, Wieser K, Zumstein M; ARCR_Pred Study Group; Muller AM. Swiss-wide multicentre evaluation and prediction of core outcomes in arthroscopic rotator cuff repair: protocol for the ARCR_Pred cohort study. BMJ Open. 2021 Apr 22;11(4):e045702. doi: 10.1136/bmjopen-2020-045702.