Results of Arthroscopic Massive Rotator Cuff Tears Repair With or Without Using Long Head of Biceps Tendon

Rotator Cuff Tears Clinical Trial

Official title:

Results of Arthroscopic Massive Rotator Cuff Tears Repair With Or Without Superior Capsular Augmentation Using Proximal Part Of Long Head Of Biceps Tendon: A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05817071
• Other study ID #: FMASU MD 246/2021
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 15, 2022
• Est. completion date: January 14, 2024

Study information

• Verified date: March 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Goal of this clinical trial is to asses the function of arthroscopic repair with or without superior capsular augmentation using biceps tendon .

Description:

All patients included in this clinical trial Will be informed by written consent will undergo a one week screening to determine the eligibility for study entry. Patients who meet the eligibility requirements Will be randomised in a single blinded manner ( patients).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: January 14, 2024
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• age 40 to 80 years old

• Patients with massive rotator cuff tear

Exclusion Criteria:

• patients with glenohumeral arthritis

• Acromioclavicular arthritis that requires distal clavicle resection

• Patients with other intra articular pathology like slap lesion

• Neural damage( brachial plexus injury)

• Revision cases

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Procedure:
• Arthroscopic massive rotator cuff repair
Arthroscopic massive rotator cuff repair without biceps tendon augmentation either partial or complete repair.
• Arthroscopic massive rotator cuff repair with superior capsular augmentation using the long head of biceps tendon
Arthroscopic massive rotator cuff repair with superior capsular augmentation using the long head of biceps tendon .

Locations

Country	Name	City	State
Egypt	Mostafa Ahmed Mohamed Mostafa,MSC	Cairo	Abbasia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional shoulder constant score (assess the change pre operative and post operative during study period completion)	Assess the change of Constant score of the patients pre operative and during follow up duration of the study on multiple periods (a multi-item functional scale assessing pain, activity of daily living , range of motion and strength of the affected shoulder. Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively.)	1- preoperative 2- six months post operative 3- one year post operative
Primary	Functional shoulder ases score (assess the change preoperative and postoperative during study period completion )	Assess the change in Ases score pre operative and post operative during study completion on multiple periods ( American shoulder and elbow surgeons standardized form)Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.	1- preoperative 2- six months post operative 3- one year post operative
Secondary	Shoulder Pain ( assess the change preoperative and postoperative during the study period completion)	Asses the change in the visual analog score ( zero equal no pain and 10 equal severest pain ) pre operative and post operative during study period on different periods	1 pre operative 2 two weeks post operative 3 six months post operative