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Not yet recruiting NCT07394348

Impact of Rotator Cuff Repair on Rehabilitation Outcome

Observational Rotator Cuff Repairs

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Jamar Handheld dynanometer.
Who it may be relevant to
Registry conditions: Rotator Cuff Repairs. Basic parameters: 50 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Impact of Biceps Tenotomy Versus Tenodesis on Rehabilitation Outcomes After Rotator Cuff Repair

Overview

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

Detailed description

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.

Interventions

  • Device Jamar Handheld dynanometer
    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.

Primary outcome measures

  • Pain level [Time frame: 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 )]
Secondary outcome measures (3)
  • Hand grip strength [Time frame: 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 )]
  • Forearm supination strength [Time frame: 3 time intervals ( pre , within 1 week post , 3 months post )]

Eligibility criteria

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. -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 38689328
  • 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. PMID 33981560

Identifiers

NCT: NCT07394348 · Rehab outcomes in Rotator cuff

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗