Rotator Cuff TearsNCT05817071
Results of Arthroscopic Massive Rotator Cuff Tears Repair With or Without Using Long Head of Biceps Tendon
A study testing Arthroscopic massive rotator cuff repair and Arthroscopic massive rotator cuff repair with superior capsular augmentation using the long head of biceps tendon in people with Rotator Cuff Tears, run by Ain Shams University at 1 site in Egypt.
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 . Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Arthroscopic massive rotator cuff repair and Arthroscopic massive rotator cuff repair with superior capsular augmentation using the long head of biceps tendon
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2022to 14 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 40 to 80 years old
- Patients with massive rotator cuff tear
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
The Goal of this clinical trial is to asses the function of arthroscopic repair with or without superior capsular augmentation using biceps tendon .
Read the 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).
- Conditions
- Rotator Cuff Tears
- Being tested
- Arthroscopic massive rotator cuff repair, Arthroscopic massive rotator cuff repair with superior capsular augmentation using the long head of biceps tendon
- Keywords
- Massive cuff tears, Biceps autograft, Arthroscopic repair partial or complete, Retear, Superior capsular augmentation
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic massive rotator cuff repairProcedure or surgery
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 or surgery
Also called Superior capsular augmentation using proximal part of the long head of biceps tendon ( LHBT), Biceps tendon autograft technique.
Arthroscopic massive rotator cuff repair with superior capsular augmentation using the long head of biceps tendon .
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic massive Rotator Cuff Tears Repair without using long head of biceps tendon augmentation | Active comparator | Arthroscopic repair either complete or partial with medialization or not by anchors without using proximal part of long head of biceps tendon) ( single row or double row )(partial or complete anatomical) Receives: Procedure: Arthroscopic massive rotator cuff repair |
| Arthroscopic Massive Rotator Cuff Tears Repair With biceps Augmentation | Experimental | • Single or double row repair technique by Rotator Cuff(RC) anchors. Biceps augmentation will be done via release and mobilize the Long Head of Biceps Tendon from bicipital groove. then the proximal part of long head of biceps tendon will be lateralized towards greater tuberosity crossing the gap by passing 1 limb of the RC anchor using suture passer (scorpion or lasso loop) and the other limb of the same anchor was passed through torn cuff. a horizontal limb of distal part biceps tendon was interpositioned between the Rotator Cuff Tears And humeral head, aiding in biological healing and strengthening poor quality rotator cuff tendons Receives: Procedure: Arthroscopic massive rotator cuff repair with superior capsular augmentation using the long head of biceps tendon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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.
Measured: 1- preoperative 2- six months post operative 3- one year post operative
Secondary outcomes (1)
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
Measured: 1 pre operative 2 two weeks post operative 3 six months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start15 Dec 2022
- Primary completion15 Jun 2023
- Study completion14 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amr Mo Abdelhady, Professor, Study chair, Faculty of medicine Ain shams universityMohamed Ha Sobhy, Professor, Study director, Faculty of medicine Ain shams universityAhmed Ha Khater, professor, Study director, Faculty of medicine Ain shams universityYahia Mo Haroun, Lecturer, Study director, Faculty of medicine Ain shams universityMostafa Ah Mostafa, Principal investigator, Faculty of medicine Ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817071
- Sponsor's protocol ID
- FMASU MD 246/2021
- Status last verified
- Mar 2023
- First submitted
- 6 Jan 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05817071
- Acronym / sponsor ID
- FMASU MD 246/2021
- Conditions
- Rotator Cuff Tears
- Keywords
- Massive cuff tears, Biceps autograft, Arthroscopic repair partial or complete, Retear, Superior capsular augmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 14 Jan 2024 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic massive Rotator Cuff Tears Repair without using long head of biceps tendon augmentation | Active comparator | Procedure: Arthroscopic massive rotator cuff repairArthroscopic repair either complete or partial with medialization or not by anchors without using proximal part of long head of biceps tendon) ( single row or double row )(partial or complete anatomical) |
| Arthroscopic Massive Rotator Cuff Tears Repair With biceps Augmentation | Experimental | Procedure: Arthroscopic massive rotator cuff repair with superior capsular augmentation using the long head of biceps tendon• Single or double row repair technique by Rotator Cuff(RC) anchors. Biceps augmentation will be done via release and mobilize the Long Head of Biceps Tendon from bicipital groove. then the proximal part of long head of biceps tendon will be lateralized towards greater tuberosity crossing the gap by passing 1 limb of the RC anchor using suture passer (scorpion or lasso loop) and the other limb of the same anchor was passed through torn cuff. a horizontal limb of distal part biceps tendon was interpositioned between the Rotator Cuff Tears And humeral head, aiding in biological healing and strengthening poor quality rotator cuff tendons |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 40 to 80 years old
- Patients with massive rotator cuff tear
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic massive rotator cuff repairArthroscopic massive rotator cuff repair without biceps tendon augmentation either partial or complete repair. | Procedure or surgery | Arthroscopic massive Rotator Cuff Tears Repair without using long head of biceps tendon augmentation |
| Arthroscopic massive rotator cuff repair with superior capsular augmentation using the long head of biceps tendonAlso: Superior capsular augmentation using proximal part of the long head of biceps tendon ( LHBT), Biceps tendon autograft technique.Arthroscopic massive rotator cuff repair with superior capsular augmentation using the long head of biceps tendon . | Procedure or surgery | Arthroscopic Massive Rotator Cuff Tears Repair With biceps Augmentation |
Primary outcome
Functional shoulder constant score (assess the change pre operative and post operative during study period completion)
Time frame: 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 )
Time frame: 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.
1 secondary outcome
Shoulder Pain ( assess the change preoperative and postoperative during the study period completion)
Time frame: 1 pre operative 2 two weeks post operative 3 six months post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amr Mo Abdelhady, Professor study chair
Faculty of medicine Ain shams university
Mohamed Ha Sobhy, Professor study director
Faculty of medicine Ain shams university
Ahmed Ha Khater, professor study director
Faculty of medicine Ain shams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic massive rotator cuff repair and Arthroscopic massive rotator cuff repair with superior capsular augmentation using the long head of biceps tendon in people with Rotator Cuff Tears, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional shoulder constant score (assess the change pre operative and post operative during study period completion) (time frame: 1- preoperative 2- six months post operative 3- one year post operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.