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

Rotator Cuff Tear Clinical Trial

— ARCR_Pred  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04321005
• Other study ID #: 2019-02076; ch20Mueller
• Status: Active, not recruiting
• Start date: June 1, 2020
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 973
• Est. completion date: September 2024
• Est. primary completion date: December 21, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

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

Locations

Country	Name	City	State
Germany	Department for Shoulder and Elbow surgery Center for Musculoskeletal Surgery Campus Virchow	Berlin
Switzerland	Kantonsspital Baden AG,	Baden	Aarau
Switzerland	ARTHRO Medics AG	Basel
Switzerland	University Hospital Basel	Basel
Switzerland	Inselspital	Bern
Switzerland	Sonnenhof	Bern
Switzerland	Kantonsspital Baselland	Binningen	Baselland
Switzerland	Hirslanden Clinique de Colline	Genève
Switzerland	University Hospital Geneva	Genève
Switzerland	Regional Hospital Lugano	Lugano
Switzerland	Hopital du Valois (RSV)	Martigny	Valais
Switzerland	Hirslanden Klinik Birshof	Münchenstein	Baselland
Switzerland	Bürgerspital Solothurn, Klinik für Orthopädie und Traumatologie	Solothurn
Switzerland	Klinik Gut	St Moritz	Graubünden
Switzerland	Klinik tür Orthopädische Chirurgie und Traumatologie des Bewegungsapparates Kantonsspital St. Gallen	St. Gallen	Saint Gallen
Switzerland	Zentrum für Orthopädie & Neurochirurgie In-Motion	Wallisellen	Zürich
Switzerland	Kantonsspital Winterthur, Klinik für Orthopädie und Traumatologie	Winterthur
Switzerland	Endoclinic	Zürich
Switzerland	Schulthess Klinik	Zürich
Switzerland	Universitätsklinik Balgrist	Zürich

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Schweizerische Versicherungsanstalt (SUVA), Swiss National Science Foundation, Swiss Orthopaedics

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Rotator cuff and biceps tendon integrity by MRI	Postoperative integrity status of the rotator cuff classified by MRI	at 12 months
Secondary	Rotator cuff muscle fatty infiltration by MRI	Rotator cuff muscle fatty infiltration by MRI	at 12 months
Secondary	Status of repair implants e.g. anchors by MRI	Status of repair implants e.g. anchors by MRI	at 12 months