NCT Number: NCT07394348
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
Trial opening soon.
Get Notified50 year–70 year
All sexes
Observational
Rotator cuff tears are common musculoskeletal conditions that are often degenerative and typically affect older adults. They may or may not be symptomatic, and their prevalence increases significantly with age, from approximately 9.7% in individuals under 20 years to 62% in those over 80 years. The rotator cuff plays a critical role in stabilizing the shoulder joint through the concavity-compression mechanism, and its dysfunction can result in shoulder instability, pain, and reduced upper limb strength. Conservative management, including physical therapy, therapeutic modalities, and medications, is considered the first-line approach for treating Rotator cuff tears , while surgical intervention is reserved for cases unresponsive to conservative treatment. Among the commonly performed surgical procedures, biceps tenotomy and biceps tenodesis are often combined with rotator cuff repair to alleviate pain and improve functional outcomes. Hand grip strength is widely recognized as a reliable indicator of overall upper limb function and may be affected by both the pathology and its surgical management. Despite its clinical relevance, limited studies have directly compared the impact of Biceps tenotomy and Biceps tenodesis on Hand grip strength. Furthermore, these surgical techniques may influence other functional outcomes, including elbow flexion strength, forearm supination strength, and pain perception. Therefore, this study seeks to investigate and compare the effects of Biceps tenotomy versus Biceps tenodesis on these parameters in patients undergoing surgical repair for rotator cuff tears.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
The participant's selection will be based on the following criteria:
Exclusion criteria
Participants will be excluded if they have any of the following criteria:
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.
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
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
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 )
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 )
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 )
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 .
Contact information is provided by the study sponsor or research team.
Cairo University
Other
Impact of Biceps Tenotomy Versus Tenodesis on Rehabilitation Outcomes After Rotator Cuff Repair
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07076069
Agnosia, Nervous System Diseases
The Bronx, New York, United States
View Trial DetailsNCT05106088
Rotator Cuff Injuries, Rotator Cuff Repairs
Cleveland, Ohio, United States
View Trial DetailsNCT07080450
Rotator Cuff Repairs
Quimper, France
View Trial Details