Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05691374
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2023-01-10
Brief Title:
Evaluation of Functional and Biomechanical Outcome by Shear-wave Elastography in the Short to Intermediate Follow-up After Arthroscopic Rotator Cuff Repair
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Evaluation of Functional and Biomechanical Outcome by Shear-wave Elastography in the Short to Intermediate Follow-up After Arthroscopic Rotator Cuff Repair
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None