Clinical trial NCT05691374: Evaluation of Functional and Biomechanical Outcome by Shear-wave Elastography in the Short to Intermediate Follow-up After Arthroscopic Rotator Cuff Repair
Official title: Evaluation of Functional and Biomechanical Outcome by Shear-wave Elastography in the Short to Intermediate Follow-up After Arthroscopic Rotator Cuff Repair
Study type: OBSERVATIONAL
Overall status: RECRUITING
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)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: DePuy Synthes
First posted: 2023-01-20
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient selection from University Hospital Basel database

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.

Detailed description: Arthroscopic repair of rotator cuff tears is commonly performed. However, recurrent tears after arthroscopic rotator cuff repair (ARCR) remain a significant clinical problem, especially in cases with large tears. Depending on literature, reported retear rates can range between 13% to 69%. Most likely, these tears reflect mechanical failure of the repair construct.

Ultrasound elastography is a recent technology and especially shear wave elastography (SWE) has experienced major developments in the past years. SWE offers an ultrasound based non-invasive quantitative tissue elasticity measurement by evaluating shear wave propagation speed which reflects the biomechanical properties of soft tissue. With this technique, the deltoid and trapezius muscle, several sections of the rotator cuff muscles and tendons as well as the proximal part of the long head of the biceps muscle can be evaluated. Results of the patient-reported outcomes and the physical examinations of the intermediate follow-up (2-5 years) will be compared with the data of the preoperative function.

It is a retrospective observational cohort study with additional prospective clinical data collection in terms of a physical examination and ultrasound examination.

There is no additional invasive procedure for this study.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Shear wave propagation velocity in kPa
timeFrame: one time assessment (at least 2 years postoperatively)
measure: Tendon integrity
timeFrame: one time assessment (at least 2 years postoperatively)
measure: Fatty infiltration (SSP, ISP, SSC, TM)
timeFrame: one time assessment (at least 2 years postoperatively)
measure: Diameter/Thickness of rotator cuff tendons (ISP, SSP, SSC, TM)
timeFrame: one time assessment (at least 2 years postoperatively)
measure: Status of implants e.g. anchors
timeFrame: one time assessment (at least 2 years postoperatively)
measure: Suture cut-through (yes/no)
timeFrame: one time assessment (at least 2 years postoperatively)
Secondary outcomes:
measure: Change in Constant Murley Score (CMS)
timeFrame: pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up
measure: Change in shoulder strength (kg) in 90° of abduction measured by handheld dynamometer
timeFrame: pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up
measure: Change in Patient-reported shoulder pain (NRS)
timeFrame: pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up
measure: Change in Patient-reported shoulder function (ASES)
timeFrame: pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up
measure: Change in Subjective Shoulder Value (SSV)
timeFrame: pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up
measure: Change in Quality of life assessed by EQ-5D-5- questionnaire
timeFrame: pre- operative, short-term (6 months postoperatively), and intermediate-term (at least 2 years) follow-up
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Department of Orthopaedic and Trauma surgery
Study officials:
affiliation: University Hospital Basel, Department of Orthopaedic and Trauma surgery
name: Andreas Müller, Prof. Dr. med.
role: STUDY_DIRECTOR
References: