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Rotator Cuff TearARCR_PredNCT04321005

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

An observational study of Rotator Cuff Tear, run by University Hospital, Basel, Switzerland at 20 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Rotator Cuff Tear
What is being tested?
arthroscopic rotator cuff reconstruction
Type of treatment
Surgery or procedure
How many people
973 participants
Where
20 sitesin 2 countries
Study dates
1 Jun 2020to 13 Nov 2024
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Patients treated for a partial or full-thickness rotator cuff tear with primarily surgical partial or complete repair by arthroscopic procedure

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

20 sites in 2 countries.

20 sites in 2 countries

Switzerland19 sites

  • Kantonsspital Baden AG,

    Baden, Aarau, 5404

  • University Hospital Basel

    Basel, 4031

  • ARTHRO Medics AG

    Basel, 4054

  • Sonnenhof

    Bern, 3006

  • Inselspital

    Bern, 3010

  • Kantonsspital Baselland

    Binningen, Basel-Landschaft, 4104

  • Hirslanden Clinique de Colline

    Geneva, 1205

  • University Hospital Geneva

    Geneva, 1205

  • Regional Hospital Lugano

    Lugano, 6903

  • Hopital du Valois (RSV)

    Martigny-Ville, Valais, 1920

  • Hirslanden Klinik Birshof

    Münchenstein, Basel-Landschaft, 4142

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

    Sankt Gallen, Canton of St. Gallen, 9007

  • Bürgerspital Solothurn, Klinik für Orthopädie und Traumatologie

    Solothurn

  • Klinik Gut

    St. Moritz, Kanton Graubünden, 7500

  • Zentrum für Orthopädie & Neurochirurgie In-Motion

    Wallisellen, Canton of Zurich, 8304

  • Kantonsspital Winterthur, Klinik für Orthopädie und Traumatologie

    Winterthur

  • Schulthess Klinik

    Zurich, 8008

  • Universitätsklinik Balgrist

    Zurich, 8008

  • Endoclinic

    Zurich, 8032

Other trials in Switzerland

Germany1 site

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

    Berlin, 13353

Other trials in Germany

About this study

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

Read the 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.

Being tested
arthroscopic rotator cuff reconstruction
Keywords
Oxford Shoulder Score (OSS), shoulder stiffness, arthroscopic rotator cuff repair
Medical subject headings
Rotator Cuff Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • arthroscopic rotator cuff reconstructionProcedure or surgery

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: at Baseline and at 6 months after surgery.

  2. 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

    Measured: at Baseline and at 6 months after surgery.

Secondary outcomes (17)

  1. 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

    Measured: 24 months

  2. 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.

    Measured: at 6 and 12 months

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

    Highest possible Weight load of the Shoulder measured by dynamometer

    Measured: at 6 and 12 months

  4. 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.

    Measured: at 6, 12 months and 24 months

  5. 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.

    Measured: at 6, 12 months and 24 months

  6. 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%

    Measured: at 6, 12 months and 24 months

  7. 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.

    Measured: at 6, 12 and 24 months

  8. Return to work, change of working condition

    Return to work, change of working condition is measure in a standardized questionnaire noting among others absences

    Measured: at 6, 12 and 24 months

  9. 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.

    Measured: at 6, 12 and 24 months

  10. 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

    Measured: at 6, 12 and 24 months

  11. 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.

    Measured: at 12 and 24 months

  12. 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)

    Measured: 6 months

  13. 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)

    Measured: 6 months

  14. 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).

    Measured: 6 months

  15. Rotator cuff and biceps tendon integrity by MRI

    Postoperative integrity status of the rotator cuff classified by MRI

    Measured: at 12 months

  16. Rotator cuff muscle fatty infiltration by MRI

    Rotator cuff muscle fatty infiltration by MRI

    Measured: at 12 months

  17. Status of repair implants e.g. anchors by MRI

    Status of repair implants e.g. anchors by MRI

    Measured: at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2020
  2. Study start1 Jun 2020
  3. Primary completion21 Dec 2023
  4. Study completion13 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
973 participants (actual)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04321005
Sponsor's protocol ID
2019-02076; ch20Mueller
Other IDs
2019
Acronym
ARCR_Pred
Status last verified
Dec 2024
First submitted
3 Mar 2020
Last updated
4 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Audige L, Baum C, Stojanov T, Rosso C, Moroder P, Suter T, Dao Trong ML, Benninger E, Moor B, Spormann C, Durchholz H, Cunningham G, Ladermann A, Schar M, Flury M, Eid K, Scheibel M, Candrian C, Jost B, Zumstein MA, Wieser K; ARCR_Pred Study Group; M Muller A. Comparison of articular-sided, bursal-sided, and intratendinous partial rotator cuff tears: outcomes of surgical repair from a multicenter cohort study. J Orthop Surg Res. 2026 Feb 19;21(1):163. doi: 10.1186/s13018-025-06643-w.

    PubMed 41715209

  • 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.

    PubMed 33888530

Questions about this trial

What is this clinical trial studying?

An observational study of Rotator Cuff Tear, run by University Hospital, Basel, Switzerland at 20 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Switzerland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-reported change in shoulder functional outcome OSS (time frame: at Baseline and at 6 months after surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04321005, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.

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