- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07394348
Impact of Rotator Cuff Repair on Rehabilitation Outcome
Impact of Biceps Tenotomy Versus Tenodesis on Rehabilitation Outcomes After Rotator Cuff Repair
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Nardin Samuel Nasief
- Phone Number: 01212426966
- Email: 10722023495578@pg.cu.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
50 all gender patients with rotator cuff tear , they will be selected based on inclusion criteria and allocated based on type of surgery either combined with long head of biceps tenotomy or tenodesis . They will be grouped according to their surgical intervention by orthopaedic surgeon into 2 cohorts .
25 patients for biceps tenotomy and 25 patients for biceps tenodesis .
Description
Inclusion Criteria:
The participant's selection will be based on the following criteria:
- Both genders adults diagnosed with ≥ 1-cm full-thickness tears of rotator cuff.
- Age ranged from 50 to 70 years .
- LHB pathology is involved that will receive ARCR combined with biceps tenotomy or tenodesis.
- Arthroscopically confirmed LHB pathology.
- Functionality according to their physical level -
Exclusion Criteria:
Participants will be excluded if they have any of the following criteria:
- Massive irreparable tears.
- Inflammatory arthritis.
- Thyroid disease.
- Glenohumeral osteoarthritis.
- Severe cervical disorders or paralysis of the axillary nerve.
- Previous surgery of the affected shoulder.
- Revision surgeries for a rotator cuff tear.
- Complete LHBT rupture. -
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Biceps tenotomy
Patients will be grouped according to their surgical intervention combined with the rotator cuff repair by orthopaedic surgeon. They will be assessed at 3 times interval ( preoperative , within 1 week post operative and after 3 months ).To identify its effect on rehabilitation outcomes in comparison to patients with biceps tenodesis . |
is a precision instrument used to measure isometric grip strength.
It is widely recognized in clinical research as the "gold standard" for assessing hand strength and general upper-body physical function due to its high test-retest reliability and inter-instrument validity.
|
|
Biceps tenodesis
Patients will be grouped according to their surgical intervention combined with the rotator cuff repair by orthopaedic surgeon. They will be assessed at 3 times interval ( preoperative , within 1 week post operative and after 3 months ).To identify its effect on rehabilitation outcomes in comparison to patients with biceps tenotomy. |
is a precision instrument used to measure isometric grip strength.
It is widely recognized in clinical research as the "gold standard" for assessing hand strength and general upper-body physical function due to its high test-retest reliability and inter-instrument validity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain level
Time Frame: 3 time intervals ( pre , within 1 week post , 3 months post )
|
Assessed by Visual analog scale : used to assess acute pain particularly effective post-operatively for tracking individual progress . The patients mark their current pain level on a 100 mm horizontal line anchored by verbal descriptors . Scoring is : 0 for No symptoms , 10 for very severe symptoms |
3 time intervals ( pre , within 1 week post , 3 months post )
|
|
shoulder function
Time Frame: 3 time intervals ( pre , within 1 week post , 3 months post )
|
Will be Assessed by Arabic version of American Shoulder and Elbow Suregeons and Constant Score questionnares * American shoulder and Elbow Surgeons used to evaluate shoulder function and pain . Patient answer 10 daily activity questions each scored from 0 ( unable) to 3 (normal function ) while the pain assessed by visual analog scale Pain scaore is converted to another 50 point Score total is 100 points ( 50 pain + 50 function ) Higher scores is indication for better shoulder function * Constant score used to assess shoulder function recovery . It has 2 sections : 1)subjective : 35 points : patient reports on pain and daily activity ability. 2)objective : 65 points : clinical measures for range of motion and strength Grading : pain + activities 0_35 points Range of motion +strength 0_65 points Strength is measured as 1 point per pound lifted for 5 sec ..25 points Score total is 100 points .. The higher is better |
3 time intervals ( pre , within 1 week post , 3 months post )
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hand grip strength
Time Frame: 3 time intervals ( pre , within 1 week post , 3 months post )
|
Will be Assessed by jamar handheld dynanometer Three trials of maximum contraction with holding for 3_5 seconds will be conducted . The highest value obtained will be used for analysis . |
3 time intervals ( pre , within 1 week post , 3 months post )
|
|
Elbow flexion strength
Time Frame: 3 time intervals ( pre , within 1 week post , 3 months post )
|
Will be Assessed by jamar handheld dynanometer Three trials of maximum contraction with holding for 3_5 seconds will be conducted . The highest value obtained will be used for analysis . |
3 time intervals ( pre , within 1 week post , 3 months post )
|
|
Forearm supination strength
Time Frame: 3 time intervals ( pre , within 1 week post , 3 months post )
|
Will be assessed by jamar handheld dynanometer Three trials of maximum contraction with holding for 3_5 seconds will be conducted . The highest value obtained will be used for analysis . |
3 time intervals ( pre , within 1 week post , 3 months post )
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Liu YC, Huang SW, Adams CR, Lin CY, Chen YP, Kuo YJ, Chuang TY. Preoperative handgrip strength can predict early postoperative shoulder function in patients undergoing arthroscopic rotator cuff repair. J Orthop Surg Res. 2024 Apr 30;19(1):270. doi: 10.1186/s13018-024-04750-8.
- Aouad D, El Rassi G. Shoulder Arthroscopic Rotator Cuff Repair With Biceps Tenodesis and Acromioplasty Using a Single Working Portal. Arthrosc Tech. 2021 Mar 22;10(4):e1125-e1129. doi: 10.1016/j.eats.2021.01.005. eCollection 2021 Apr.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- Rehab outcomes in Rotator cuff
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.
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