Surgical Safety and Effectiveness in Orthopedics: Swiss-wide Multicenter Evaluation and Prediction of Core Outcomes in Arthroscopic Rotator Cuff Reconstruction

NCT04321005 | Completed

• 1 other identifier: 2019-02076; ch20Mueller
• Study Type: observational
• Target: 973
• Locations: 2 countries
• Sites: 20

Brief Summary

Surgical safety and effectiveness in orthopedics: Swiss-wide multicenter evaluation and prediction of core outcomes in arthroscopic rotator cuff reconstruction.

Conditions

Rotator Cuff Tear

Keywords

Oxford Shoulder Score (OSS); shoulder stiffness; arthroscopic rotator cuff repair

Outcome Measures

Primary Outcomes (2)

• Patient-reported change in shoulder functional outcome OSS

  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).

  at Baseline and at 6 months after surgery.

• Change of shoulder stiffness

  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

  at Baseline and at 6 months after surgery.

Secondary Outcomes (17)

• Local AEs (Adverse events) according to the ARCR Core Event Set (CES)

  24 months

• Constant Murley Score (CMS)

  at 6 and 12 months

• Shoulder strength (kg) in abduction at 6 and 12 months

  at 6 and 12 months

• Change in Patient-reported shoulder pain on a Numeric Rating Scale (NRS)

  at 6, 12 months and 24 months

• Change in Oxford Shoulder Score (OSS)

  at 6, 12 months and 24 months

Interventions

arthroscopic rotator cuff reconstruction PROCEDURE

arthroscopic rotator cuff reconstruction and assessment with evaluation and prediction of core outcomes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Swiss National Science Foundation: collaborator
• Swiss Orthopaedics: collaborator
• Schweizerische Versicherungsanstalt (SUVA): collaborator

Study Sites (20)

Department for Shoulder and Elbow surgery Center for Musculoskeletal Surgery Campus Virchow

Berlin, 13353, Germany

Location

Kantonsspital Baden AG,

Baden, Aarau, 5404, Switzerland

Location

Kantonsspital Baselland

Binningen, Basel-Landschaft, 4104, Switzerland

Location

Hirslanden Klinik Birshof

Münchenstein, Basel-Landschaft, 4142, Switzerland

Location

Klinik tür Orthopädische Chirurgie und Traumatologie des Bewegungsapparates Kantonsspital St. Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

Zentrum für Orthopädie & Neurochirurgie In-Motion

Wallisellen, Canton of Zurich, 8304, Switzerland

Location

Klinik Gut

St. Moritz, Kanton Graubünden, 7500, Switzerland

Location

Hopital du Valois (RSV)

Martigny-Ville, Valais, 1920, Switzerland

Location

University Hospital Basel

Basel, 4031, Switzerland

Location

ARTHRO Medics AG

Basel, 4054, Switzerland

Location

Sonnenhof

Bern, 3006, Switzerland

Location

Inselspital

Bern, 3010, Switzerland

Location

Hirslanden Clinique de Colline

Geneva, 1205, Switzerland

Location

University Hospital Geneva

Geneva, 1205, Switzerland

Location

Regional Hospital Lugano

Lugano, 6903, Switzerland

Location

Bürgerspital Solothurn, Klinik für Orthopädie und Traumatologie

Solothurn, Switzerland

Location

Kantonsspital Winterthur, Klinik für Orthopädie und Traumatologie

Winterthur, Switzerland

Location

Schulthess Klinik

Zurich, 8008, Switzerland

Location

Universitätsklinik Balgrist

Zurich, 8008, Switzerland

Location

Endoclinic

Zurich, 8032, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 33888530 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Andreas Müller, PD Dr.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 25, 2020
• Study Start: June 1, 2020
• Primary Completion: December 21, 2023
• Study Completion: November 13, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

DE (1); CH (19)