Impact of Rotator Cuff Repair on Rehabilitation Outcome

NCT07394348 | Not Yet Recruiting

• 1 other identifier: Rehab outcomes in Rotator cuff
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Rotator Cuff Repairs

Keywords

Biceps tenotomy; Biceps tenodesis; Rehabilitation outcomes; Hand grip strength

Outcome Measures

Primary Outcomes (2)

• 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

  3 time intervals ( pre , within 1 week post , 3 months post )

• 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

  3 time intervals ( pre , within 1 week post , 3 months post )

Secondary Outcomes (3)

• Hand grip strength

  3 time intervals ( pre , within 1 week post , 3 months post )

• Elbow flexion strength

  3 time intervals ( pre , within 1 week post , 3 months post )

• Forearm supination strength

  3 time intervals ( pre , within 1 week post , 3 months post )

Study Arms (2)

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 .

Device: Jamar Handheld dynanometer

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.

Device: Jamar Handheld dynanometer

Interventions

Jamar Handheld dynanometer DEVICE

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; Biceps tenotomy

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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 .

You may qualify if:

• 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 -

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Cairo University: lead

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

Central Study Contacts

Nardin Samuel Nasief

CONTACT

01212426966; 10722023495578@pg.cu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nardin Samuel Nasief : Principal Investigator

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 6, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02