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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05817071

Enrollment

Registered

2023-04-18

Start date

2022-12-15

Completion date

2024-01-14

Last updated

2023-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Tears

Keywords

Massive cuff tears, Biceps autograft, Arthroscopic repair partial or complete, Retear, Superior capsular augmentation

Brief summary

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

Detailed 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).

Interventions

PROCEDUREArthroscopic massive rotator cuff repair

Arthroscopic massive rotator cuff repair without biceps tendon augmentation either partial or complete repair.

PROCEDUREArthroscopic 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 .

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Functional shoulder constant score (assess the change pre operative and post operative during study period completion)	1- preoperative 2- six months post operative 3- one year post operative	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.)
Functional shoulder ases score (assess the change preoperative and postoperative during study period completion )	1- preoperative 2- six months post operative 3- one year post operative	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.

Secondary

Measure	Time frame	Description
Shoulder Pain ( assess the change preoperative and postoperative during the study period completion)	1 pre operative 2 two weeks post operative 3 six months post operative	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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026