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

Ain Shams University30 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Rotator Cuff Tears

Interventions

Arthroscopic massive rotator cuff repairPROCEDURE

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 tendonPROCEDURE

Arthroscopic massive rotator cuff repair with superior capsular augmentation using the long head of biceps tendon .

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Mostafa Ahmed Mohamed Mostafa,MSC

Cairo, Abbasia, Egypt

Outcomes

Primary Outcomes

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.)

Time frame: 1- preoperative 2- six months post operative 3- one year post operative

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.

Time frame: 1- preoperative 2- six months post operative 3- one year post operative

Secondary Outcomes

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

Time frame: 1 pre operative 2 two weeks post operative 3 six months post operative

Data from ClinicalTrials.gov

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