- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07289334
Tenotomy Versus no Tenotomy LHB in Rotator Cuff Repair
Tenotomy Versus no Tenotomy of the Long Head of the Biceps in Rotator Cuff Repair: Clinical-functional Analysis and Ultrasound Evaluation
The function of the long head of the biceps tendon (LHBT) in the glenohumeral joint generates controversy among researchers. For some, the tendon does not have a significant function in the shoulder, while others consider it acts as a depressor of the humeral head and a stabilizer of the joint. These functions may be enhanced in cases of rotator cuff injuries, where compensatory hypertrophy and/or instability of the LHBT can occur, which can also be a source of pain. One of the imaging techniques used for diagnosing these injuries is ultrasound.
Initially, G. Walch proposed tenotomy of the LHBT in massive rotator cuff tears to improve pain and, in some cases, shoulder function. Currently, many authors advocate tenotomy of the LHBT as an adjunct to rotator cuff repair to avoid postoperative pain. However, there is no evidence that this procedure improves the clinical outcomes of isolated rotator cuff repair.
Based on the pathophysiology of the LHBT associated with rotator cuff injuries and the current trend to perform tenotomies in conjunction with cuff repair, the objectives of this doctoral thesis project were:
To compare the clinical and imaging outcomes of arthroscopic rotator cuff repairs with and without LHBT tenotomy.
To analyze the position and cross-sectional area of the LHBT in the bicipital groove using ultrasound in cases with and without tenotomy.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 40 and 65 years
- Partial supraspinatus tears (≥ 50% thickness)
- Complete supraspinatus tears ≤ 3 cm in the coronal plane
- Muscle atrophy less than stage 2 according to Thomazeau
- Presence of the LHBT in the bicipital groove
Exclusion Criteria:
- Patients younger than 40 or older than 65 years
- LHBT rupture
- Partial supraspinatus tears < 50% thickness
- Supraspinatus tears > 3 cm
- Tears of other rotator cuff tendons, with or without supraspinatus involvement
- Traumatic tears with surgery performed less than 3 months after injury
- Muscle atrophy ≥ stage 2 Thomazeau
- Associated degenerative glenohumeral pathology (> Samilson 1)
- Previous shoulder surgeries
- Previous shoulder infections
- Associated peripheral neurological injuries
- Degenerative neurological conditions
- Patients who refused to sign informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: NO TENOTOMY
NO TENOTOMY OF LHBT + ROTATOR CUFF REPAIR
|
ROTATOR CUFF REPAIR
|
|
Experimental: TENOTOMY
TENOTOMY OF LHBT + ROTATOR CUFF REPAIR
|
ROTATOR CUFF REPAIR
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Constant Murley
Time Frame: 24 month
|
100-point standardized tool for assessing shoulder function, comprising four domains Pain (0-15 points) daily life activity (0-20 points) range of motion (0-40 points) strenght (0-25 points) 0 (the worst) - 100 (the best) |
24 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ASES
Time Frame: 24 MONTHS
|
The ASES score (American Shoulder and Elbow Surgeons score) is a 100-point questionnaire used to assess shoulder function and pain, with a higher score indicating better outcomes. From 0 (worst) to 100 (best). |
24 MONTHS
|
|
cross sectional area of the LHBT
Time Frame: 24 months
|
Ultrasound Imaging: Integrity of the supraspinatus tendon (SST) repair, presence of the long head of the biceps tendon (LHBT) in the bicipital groove (BG), and cross-sectional area of the LHBT at three levels of the BG (proximal, middle, and distal). mesured in mm2 |
24 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02-14-105-018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rotator Cuff Tears
-
Xiros LtdRecruitingRotator Cuff Tear | Rotator Cuff Injuries | Rotator Cuff Tears | Rotator Cuff Tears of the ShoulderUnited Kingdom
-
ZuriMED Technologies Inc.RecruitingRotator Cuff Tear | Rotator Cuff Tears | Rotator Cuff Tears of the ShoulderUnited States
-
BAAT Medical Products B.V.Active, not recruiting
-
Gazi UniversityActive, not recruitingMassive Irreparable Rotator Cuff TearsTurkey (Türkiye)
-
Atreon OrthopedicsCompletedRotator Cuff Tears | Full-thickness Rotator Cuff TearsUnited States
-
Parc de Salut MarHospital Clinic of Barcelona; Hospital Universitario Fundación Jiménez Díaz; Hospital... and other collaboratorsActive, not recruitingShoulder Disease | Massive Rotator Cuff TearsSpain
-
BAAT Medical Products B.V.Not yet recruiting
-
Anika Therapeutics, Inc.RecruitingRotator Cuff Tears of the ShoulderUnited States
-
Sohag UniversityActive, not recruitingRotator Cuff Tears of the ShoulderEgypt
-
University of UtahEnrolling by invitationStudying the Genetic Relationship of Rotator Cuff TearsUnited States
Clinical Trials on ROTATOR CUFF REPAIR
-
Smith & Nephew, Inc.TerminatedRotator Cuff InjuriesUnited States, Hong Kong, United Kingdom, France, Singapore, Switzerland, Australia, Canada
-
CONMED CorporationRecruitingRotator Cuff TearsUnited States
-
Göker Utku değerSuspendedRotator Cuff Tears | Micro FractureTurkey
-
Seoul National University HospitalCompleted
-
Columbia UniversityCTM BiomedicalRecruitingRotator Cuff TearUnited States
-
BAAT Medical Products B.V.Not yet recruiting
-
University of CalgaryNot yet recruiting
-
Hospital Ambroise Paré ParisCompletedRotator Cuff Tears | Frozen ShoulderFrance
-
La Tour HospitalUnknown