Impact of Rotator Cuff Repair on Rehabilitation Outcome
ConditionRotator Cuff Repairs
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-70
SponsorCairo University
About this trial
This study will investigate the difference between BTT (biceps tenotomy ) versus BTD (biceps tenodesis)in patients undergoing rotator cuff repair on postoperative shoulder pain levels, shoulder function, HGS, forearm supination muscle strength, elbow flexion strength
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Massive irreparable tears.
Inflammatory arthritis.
Thyroid disease.
Glenohumeral osteoarthritis.
Trial 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 .
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Jamar Handheld dynanometer
Deviceis 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Biceps tenotomy1 intervention
Group B: Biceps tenodesis1 intervention
Trial outcomes
Primary outcomes
1
Pain level
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
Time frame
3 time intervals ( pre , within 1 week post , 3 months post )2
shoulder function
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
Time frame
3 time intervals ( pre , within 1 week post , 3 months post )Secondary outcomes
1
Hand grip strength
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 .
Time frame
3 time intervals ( pre , within 1 week post , 3 months post )2
Elbow flexion strength
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 .
Time frame
3 time intervals ( pre , within 1 week post , 3 months post )3
Forearm supination strength
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 .
Time frame
3 time intervals ( pre , within 1 week post , 3 months post )Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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