Evaluating outcomes after rotator cuff repair using ultrasound technology
Evaluation of Functional and Biomechanical Outcome by Shear-wave Elastography in the Short to Intermediate Follow-up After Arthroscopic Rotator Cuff Repair
This study is testing how well rotator cuff repairs work by using ultrasound technology to see how the shoulder muscles are healing over a few years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel) |
| Trial ID | NCT05691374 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the functional and biomechanical outcomes of patients who underwent arthroscopic rotator cuff repair (ARCR) between 2015 and 2020. Utilizing shear-wave elastography (SWE), a non-invasive ultrasound technique, the study will measure the elasticity and structural properties of the rotator cuff and associated muscles over a follow-up period of 2 to 5 years. The results will be compared to preoperative data and the healthy contralateral side to evaluate the effectiveness of the surgical repair. The study involves retrospective data collection alongside prospective clinical evaluations.
Who should consider this trial
Good fit: Ideal candidates are individuals who had ARCR surgery for specific types of rotator cuff tears between 2015 and 2020.
Not a fit: Patients who have undergone revision surgery or have postoperative complications such as infections will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of rotator cuff repairs and help improve postoperative outcomes for patients.
How similar studies have performed: While the use of shear-wave elastography is a relatively novel approach in this context, similar studies have shown promise in evaluating soft tissue properties.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basel
- University Hospital Basel, Department of Orthopaedic and Trauma surgery — Basel, Switzerland (Recruiting)
Study contacts
- Study coordinator: Dominik M Bühler, Dr. med.
- Email: dominik.buehler@usb.ch
- Phone: +41 61 556 59 69
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.