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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Rotator Cuff Tear
• Intervention / Treatment: Procedure: 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 Type: Observational
• Enrollment (Estimated): 985

Contacts and Locations

• Study Contact: Name: Andreas Müller, PD Dr.; Phone Number: 061 328 78 13; Email: A.Mueller@usb.ch
• Study Contact Backup: Name: Laurent Audigé, Prof Dr.; Phone Number: 079 687 17 23; Email: laurent.audige@usb.ch

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Department for Shoulder and Elbow surgery Center for Musculoskeletal Surgery Campus Virchow
• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel
  • Basel, Switzerland, 4054
    • ARTHRO Medics AG
  • Bern, Switzerland, 3010
    • Inselspital
  • Bern, Switzerland, 3006
    • Sonnenhof
  • Genève, Switzerland, 1205
    • University Hospital Geneva
  • Genève, Switzerland, 1205
    • Hirslanden Clinique de Colline
  • Lugano, Switzerland, 6903
    • Regional Hospital Lugano
  • Solothurn, Switzerland
    • Bürgerspital Solothurn, Klinik für Orthopädie und Traumatologie
  • Winterthur, Switzerland
    • Kantonsspital Winterthur, Klinik für Orthopädie und Traumatologie
  • Zürich, Switzerland, 8008
    • Schulthess Klinik
  • Zürich, Switzerland, 8008
    • Universitätsklinik Balgrist
  • Zürich, Switzerland, 8032
    • Endoclinic
  • Aarau
    • Baden, Aarau, Switzerland, 5404
      • Kantonsspital Baden AG,
  • Baselland
    • Binningen, Baselland, Switzerland, 4104
      • Kantonsspital Baselland
    • Münchenstein, Baselland, Switzerland, 4142
      • Hirslanden Klinik Birshof
  • Graubünden
    • St Moritz, Graubünden, Switzerland, 7500
      • Klinik Gut
  • Saint Gallen
    • St. Gallen, Saint Gallen, Switzerland, 9007
      • Klinik tür Orthopädische Chirurgie und Traumatologie des Bewegungsapparates Kantonsspital St. Gallen
  • Valais
    • Martigny, Valais, Switzerland, 1920
      • Hopital du Valois (RSV)
  • Zürich
    • Wallisellen, Zürich, Switzerland, 8304
      • Zentrum für Orthopädie & Neurochirurgie In-Motion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local AEs (Adverse events) according to the ARCR Core Event Set (CES)	Recurrent defect of repaired tendon(s) at 12 months: at least one repaired tendon is diagnosed with a recurrent defect by ultrasound examination.- Persistent or worsening pain; Infection; Any local event	24 months
Constant Murley Score (CMS)	The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The scale is from 1 to 100 with higher scores indicating better outcome.	at 6 and 12 months
Shoulder strength (kg) in abduction at 6 and 12 months	Highest possible Weight load of the Shoulder measured by dynamometer	at 6 and 12 months
Change in Patient-reported shoulder pain on a Numeric Rating Scale (NRS)	The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. A Higher Score means a worse outcome. The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes.	at 6, 12 months and 24 months
Change in Oxford Shoulder Score (OSS)	The Oxford Shoulder Score (OSS) is a validated patient-reported outcome measure (PROM). It's a shoulder-specific instrument designed to assess the outcome of all shoulder surgeries (with the exception of instability surgery). The combined total gives a minimum score of 12 and a maximum of 60. Higher scores in the OSS imply worse functionality while lower scores imply better functionality.	at 6, 12 months and 24 months
Subjective Shoulder Value (SSV)	The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%	at 6, 12 months and 24 months
Nonrestorative sleep (NRS) to assess Patient-reported quality of sleep	Nonrestorative sleep (NRS) is defined as the subjective experience that sleep has not been sufficiently refreshing or restorative. On a scale from 0-10, 0 is best possible outcome measure and 10 is worst possible outcome measure.	at 6, 12 and 24 months
Return to work, change of working condition	Return to work, change of working condition is measure in a standardized questionnaire noting among others absences	at 6, 12 and 24 months
PROMIS Depression and Anxiety Short Formto assess level of depression and anxiety	Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) scores. For PROMIS measures, higher scores equals more of the concept being measured.	at 6, 12 and 24 months
Patient perceived shoulder functionality change, acceptability of own symptom state	Patient perceived shoulder functionality change, acceptability of own symptom state are measured with emphasis on minimally clinically important differences as stated in the cited literature with the according scored measurements	at 6, 12 and 24 months
Quality of life (utilities and general health): EQ-5D-5L	Measured through EuroQoL version (EQ-5D-5L). The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. This tool has an overall health scale where the rater selects a number between 1-100 to describe the condition of their health, 1 being the worst and 100 being the best possible outcome.	at 12 and 24 months
Adverse event (AE) assessment: AEs reported by clinicians and patients	AEs reported by clinicians and patients (including non-local AEs within 6 months after surgery) b. Final independent surgeon and patient-rated assessment of AEs according to perceived severity and relation to treatment (according to perceived severity (rating scale from 0 [no complication] to 100 [death] [67]) and disturbance) c. Comprehensive Complication Index (CCI)	6 months
Adverse event (AE) assessment: Final independent surgeon and patient-rated assessment of AEs	Final independent surgeon and patient-rated assessment of AEs according to perceived severity and relation to treatment (according to perceived severity (rating scale from 0 [no complication] to 100 [death]) and disturbance)	6 months
Adverse event (AE) assessment:Comprehensive Complication Index (CCI)	Comprehensive Complication Index (CCI): The Comprehensive Complication Index is based on the complication grading by Clavien-Dindo Classification and implements every occurred complication after an intervention. The overall morbidity is reflected on a scale from 0 (no complication) to 100 (death).	6 months
Rotator cuff and biceps tendon integrity by MRI	Postoperative integrity status of the rotator cuff classified by MRI	at 12 months
Rotator cuff muscle fatty infiltration by MRI	Rotator cuff muscle fatty infiltration by MRI	at 12 months
Status of repair implants e.g. anchors by MRI	Status of repair implants e.g. anchors by MRI	at 12 months

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Swiss National Science Foundation; Swiss Orthopaedics; Schweizerische Versicherungsanstalt (SUVA)
• Investigators: Principal Investigator: Andreas Müller, PD Dr., University Hospital, Basel, Switzerland

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: March 24, 2020
• First Posted (Actual): March 25, 2020

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: arthroscopic rotator cuff repair; Oxford Shoulder Score (OSS); shoulder stiffness
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 2019-02076; ch20Mueller

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No