Evaluation of Functional and Biomechanical Outcome by Shear-wave Elastography in the Short to Intermediate Follow-up After Arthroscopic Rotator Cuff Repair

NCT05691374 | Recruiting

• 1 other identifier: 2022-02061; mu23Mueller
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This exploratory project will evaluate the biomechanical and functional intermediate-term outcome (2 to 5 years) after arthroscopic rotator cuff repair (ARCR) with modern non-invasive ultrasound techniques (especially shear wave elastography (SWE)), standardized physical examinations and patient-reported outcomes. It is to evaluate the biomechanical properties of tendons and muscles of the rotator cuff, as well as the biceps muscle after ARCR and to compare elasticity and structural properties to the healthy contralateral side.

Conditions

Arthroscopic Rotator Cuff Repair (ARCR)

Keywords

shear-wave elastography (SWE); rotator cuff muscle; biceps muscle; deltoid muscle; trapezius muscle; functional outcome; biomechanical outcome; biceps tendon; infraspinatus muscle (ISP); teres minor muscle (TM); subscapularis muscle (SSC); supraspinatus muscle (SSP)

Outcome Measures

Primary Outcomes (6)

• Shear wave propagation velocity in kPa

  Elasticity of tendon and muscle (shear wave propagation velocity in kPa)

  one time assessment (at least 2 years postoperatively)

• Tendon integrity

  Ultrasound of the repaired rotator cuff and biceps tendon (SSP, ISP, SSC, TM, long head of biceps)

  one time assessment (at least 2 years postoperatively)

• Fatty infiltration (SSP, ISP, SSC, TM)

  Fatty infiltration of the repaired rotator cuff (SSP, ISP, SSC, TM) by ultrasound

  one time assessment (at least 2 years postoperatively)

• Diameter/Thickness of rotator cuff tendons (ISP, SSP, SSC, TM)

  Diameter/Thickness of rotator cuff tendons (ISP, SSP, SSC, TM) by ultrasound

  one time assessment (at least 2 years postoperatively)

• Status of implants e.g. anchors

  Status of implants e.g. anchors by ultrasound

  one time assessment (at least 2 years postoperatively)

• Suture cut-through (yes/no)

  Suture cut-through (yes/no) by ultrasound

  one time assessment (at least 2 years postoperatively)

Secondary Outcomes (6)

• Change in Constant Murley Score (CMS)

  pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up

• Change in shoulder strength (kg) in 90° of abduction measured by handheld dynamometer

  pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up

• Change in Patient-reported shoulder pain (NRS)

  pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up

• Change in Patient-reported shoulder function (ASES)

  pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up

• Change in Subjective Shoulder Value (SSV)

  pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up

Interventions

Ultrasound (US) examination PROCEDURE

Shear-Wave Elastography (SWE) measurements of operated shoulder (quality, elasticity of repaired tendon) compared to healthy contralateral side. Parameters documented by regular US: Diameter of repaired tendon/ tendon thickness (mm), Rotator cuff muscle fatty infiltration (Grade 0-4), Signs of suture cut-through (yes \| no), Signs of anchor displacement and location (lateral\|medial row), Location of defect (at the foot print\|medial cuff failure), Status of long biceps tendon (intact\|in continuity\|defect). Tissue elasticity measured by SWE in longitudinal orientation (in passive state and with active tension): Trapezius and Deltoid muscle: uninjured superficial muscle for individual patient muscle quality, SSP muscle and tendon: anterior and posterior part, SSC muscle and tendon: cranial and caudal part, ISP muscle and tendon, Biceps muscle and tendon: native (intraarticular) or subpectoral tenodesis (extraarticular)

Clinical examination PROCEDURE

Clinical examination for shoulder range of motion and strength measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient selection from University Hospital Basel database

You may qualify if:

• year of surgery between 2015 and 2020
• ARCR surgery in cases of:
• Partial or complete supraspinatus (SSP) tear
• Partial or complete supraspinatus (ISP) tear
• Partial or complete subscapularis (SSC) tear
• Combined SSP, ISP and SSC tear
• with or without biceps tenodesis during same procedure
• able to understand the content of the patient information / consent form and give consent to take part in the study

You may not qualify if:

• revision surgery (prior repair of the rotator cuff in the same shoulder)
• postoperative infections
• patients with a language barrier hindering questionnaire completion (either in German, French, Italian or English)
• legal incompetence
• not eligible for Ultrasound (BMI \>35, persistent frozen shoulder)
• Prior surgery or injury of the contralateral shoulder

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• DePuy Synthes: collaborator

Study Sites (1)

University Hospital Basel, Department of Orthopaedic and Trauma surgery

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Interventions

High-Energy Shock Waves; Restraint, Physical

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Andreas Müller, Prof. Dr. med.

  University Hospital Basel, Department of Orthopaedic and Trauma surgery

  STUDY DIRECTOR

Central Study Contacts

Dominik M Bühler, Dr. med.

CONTACT

+41 61 556 59 69; dominik.buehler@usb.ch

Ilona Ahlborn

CONTACT

+41 79 753 37 24; ilona.ahlborn@usb.ch

Study Design

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

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 20, 2023
• Study Start: December 22, 2022
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

CH (1)