Subscapularis Muscle StrainNCT05960812
Skillful Neglect Vs Repair For Subscapularis Tear Associated With Posterosuperior Cuff Tears Repair.
A study testing skillful neglect Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy . and arthroscopic repair Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy . in people with Subscapularis Muscle Strain, run by Mohamed Ashraf Abdallah at 1 site in Egypt.
Trial summary
The purpose of this study is to compare functional outcomes of Skillful Neglect \& arthroscopic repair of upper border subscapularis tear in La fosse type 1 and type 2 with biceps tenotomy in non-athletes,30 shoulders subdivided randomly into 2 groups, 15 patients in group 1 (patient treated by skillful neglect with… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Subscapularis Muscle Strain
- What is being tested?
- skillful neglect Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy . and arthroscopic repair Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy .
- 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
- 30 Sep 2022to 26 Sep 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with combined upper subscapularis border tear in Lafosse type 1 and type 2.
Who cannot join
- Glenohumeral arthritis.
- Patients with other intra-articular pathology like SLAP lesions.
- Neural damage (Brachial plexus injury).
- Revision cases.
- Patient with subscapularis border tear type 3, type 4, and type 5.
Trial locations and contacts
1 site in 1 country.
Yahia Mo Haroun contact
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Hospitals
Cairo
mohamed ashraf, master, 00201022677132, mohamedkhamis657@gmail.com
About this study
Official title: Skillful Neglect Vs Repair For Upper Border Subscapularis Tear Associated With Posterosuperior Cuff Tears Repair In Non-Athletes: A Randomized Controlled Trial
The purpose of this study is to compare functional outcomes of Skillful Neglect \& arthroscopic repair of upper border subscapularis tear in La fosse type 1 and type 2 with biceps tenotomy in non-athletes,30 shoulders subdivided randomly into 2 groups, 15 patients in group 1 (patient treated by skillful neglect with biceps tenotomy) and 15 patients in group 2 (patients treated by arthroscopic repair with biceps tenotomy)
Read the detailed description
patients are randomized chosen then a shoulder arthroscope is done for all patients with biceps tenotomy but in group1 the investigators are neglecting the upper border tears and in group 2 the investigators are repairing upper border tears with anchors then after the procedure is completed the investigators will follow up by ASES score
- Conditions
- Subscapularis Muscle Strain
- Being tested
- skillful neglect Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy ., arthroscopic repair Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy .
- Keywords
- Rotator cuff tear
- 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.
skillful neglect Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy .Procedure or surgery
The following technique will be utilized for confirm isolated or combined upper subscapularis border partial tear conservative treatment which is considered the standard technique.
- Semisetting position under GA.
- Standard shoulder arthroscopy with standard portals for RC repair.
- Inspection of articular surface of rotator cuff and biceps tendon.
- Bursectomy, visualization of all rotators.
- Mobilization is done for associated rotator tears by shaver and radiofrequency device.
- Both preoperative Statistics randomization that is used to determine which case will be repaired and intraoperative loss of tension of the elongated aspect of the tendon are used to confirm diagnosis and treatment of upper subscapularis border tear.
- Skillful neglect to the tear.
- Rotator repair technique by RC anchors
- Biceps Tenotomy will be done in all cases by cutting of LHBT.
arthroscopic repair Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy .Procedure or surgery
The following technique will be utilized for confirm isolated or combined upper subscapularis border partial tear repair which is considered the standard technique.
- Semisetting position under GA.
- Standard shoulder arthroscopy with standard portals for RC repair.
- Inspection of articular surface of rotator cuff and biceps tendon.
- Bursectomy, visualization of all rotators.
- Mobilization is done for associated rotator tears by shaver and radiofrequency device.
- Both preoperative Statistics randomization that is used to determine which case will be repaired and intraoperative loss of tension of the elongated aspect of the tendon are used to confirm diagnosis and treatment of upper subscapularis border tear.
- Skillful neglect to the tear.
- Rotator repair technique by RC anchors
- Biceps Tenotomy will be done in all cases by cutting of LHBT.
| Study group | Role | What they receive |
|---|---|---|
| group 1 (patient treated by skillful neglect with biceps tenotomy) | Active comparator | neglect of upper border subscapularis tear and doing biceps tenotomy Receives: Procedure: skillful neglect Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy .; Procedure: arthroscopic repair Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy . |
| group 2 (patient treated by arthroscopic repair with biceps tenotomy) | Active comparator | repair of upper border subscapularis tear and doing biceps tenotomy Receives: Procedure: skillful neglect Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy .; Procedure: arthroscopic repair Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy . |
What is being measured
The primary outcome is the main question the study is designed to answer.
american shoulder elbow score
scale that evaluates two dimensions of shoulder function: pain and performance in activities of daily living. Each of the two domains make up for 50 of the 100 points.
Measured: after 6months and 12 months
Secondary outcomes (1)
Visual analogue score
subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Measured: Post operative 6months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start30 Sep 2022
- Primary completion26 Sep 2024 (estimated)
- Study completion26 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subscapularis Muscle StrainStudies of the same condition, open and under way.
- 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Ashraf Abdallah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Ashraf Abdallah, Ain Shams University
- Investigators
- mohamed as abdallah, master, Principal investigator, Ain Shams UniversityAmr Mo Abdelhady, Study chair, Ain Shams UniversityMaged Mo Samy, Study director, Ain Shams UniversityMohamed Ha Sobhy, Study director, Ain Shams UniversityYahia Mo Haroun, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960812
- Sponsor's protocol ID
- FMASU MD 218/2022
- Status last verified
- Sep 2023
- First submitted
- 20 May 2023
- Last updated
- 22 Sep 2023
- Results posted
- 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 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skillful Neglect Vs Repair For Upper Border Subscapularis Tear Associated With Posterosuperior Cuff Tears Repair In Non-Athletes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05960812
- Acronym / sponsor ID
- FMASU MD 218/2022
- Conditions
- Subscapularis Muscle Strain
- Keywords
- Rotator cuff tear
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mohamed Ashraf AbdallahUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 26 Sep 2024 (estimated)
- Study completion
- 26 Sep 2024 (estimated)
- First posted
- 27 Jul 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 purpose of this study is to compare functional outcomes of Skillful Neglect \& arthroscopic repair of upper border subscapularis tear in La fosse type 1 and type 2 with biceps tenotomy in non-athletes,30 shoulders subdivided randomly into 2 groups, 15 patients in group 1 (patient treated by skillful neglect with biceps tenotomy) and 15 patients in group 2 (patients treated by arthroscopic repair with biceps tenotomy)
Detailed description
patients are randomized chosen then a shoulder arthroscope is done for all patients with biceps tenotomy but in group1 the investigators are neglecting the upper border tears and in group 2 the investigators are repairing upper border tears with anchors then after the procedure is completed the investigators will follow up by ASES score
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 (patient treated by skillful neglect with biceps tenotomy) | Active comparator | Procedure: skillful neglect Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy ., Procedure: arthroscopic repair Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy .neglect of upper border subscapularis tear and doing biceps tenotomy |
| group 2 (patient treated by arthroscopic repair with biceps tenotomy) | Active comparator | Procedure: skillful neglect Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy ., Procedure: arthroscopic repair Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy .repair of upper border subscapularis tear and doing biceps tenotomy |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with combined upper subscapularis border tear in Lafosse type 1 and type 2.
Key exclusion criteria (5 listed)
- Glenohumeral arthritis.
- Patients with other intra-articular pathology like SLAP lesions.
- Neural damage (Brachial plexus injury).
- Revision cases.
- Patient with subscapularis border tear type 3, type 4, and type 5.
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 |
|---|---|---|
| skillful neglect Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy .The following technique will be utilized for confirm isolated or combined upper subscapularis border partial tear conservative treatment which is considered the standard technique. * Semisetting position under GA. * Standard shoulder arthroscopy with standard portals for RC repair. * Inspection of articular surface of rotator cuff and biceps tendon. * Bursectomy, visualization of all rotators. * Mobilization is done for associated rotator tears by shaver and radiofrequency device. * Both preoperative Statistics randomization that is used to determine which case will be repaired and intraoperative loss of tension of the elongated aspect of the tendon are used to confirm diagnosis and treatment of upper subscapularis border tear. * Skillful neglect to the tear. * Rotator repair technique by RC anchors * Biceps Tenotomy will be done in all cases by cutting of LHBT. | Procedure or surgery | group 1 (patient treated by skillful neglect with biceps tenotomy), group 2 (patient treated by arthroscopic repair with biceps tenotomy) |
| arthroscopic repair Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy .The following technique will be utilized for confirm isolated or combined upper subscapularis border partial tear repair which is considered the standard technique. * Semisetting position under GA. * Standard shoulder arthroscopy with standard portals for RC repair. * Inspection of articular surface of rotator cuff and biceps tendon. * Bursectomy, visualization of all rotators. * Mobilization is done for associated rotator tears by shaver and radiofrequency device. * Both preoperative Statistics randomization that is used to determine which case will be repaired and intraoperative loss of tension of the elongated aspect of the tendon are used to confirm diagnosis and treatment of upper subscapularis border tear. * Skillful neglect to the tear. * Rotator repair technique by RC anchors * Biceps Tenotomy will be done in all cases by cutting of LHBT. | Procedure or surgery | group 1 (patient treated by skillful neglect with biceps tenotomy), group 2 (patient treated by arthroscopic repair with biceps tenotomy) |
Primary outcome
american shoulder elbow score
Time frame: after 6months and 12 months
scale that evaluates two dimensions of shoulder function: pain and performance in activities of daily living. Each of the two domains make up for 50 of the 100 points.
1 secondary outcome
Visual analogue score
Time frame: Post operative 6months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: No
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.
Yahia Mo Haroun contact
mohamed as abdallah, master principal investigator
Ain Shams University
Amr Mo Abdelhady study chair
Ain Shams University
Maged Mo Samy study director
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 skillful neglect Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy . and arthroscopic repair Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy . in people with Subscapularis Muscle Strain, run by Mohamed Ashraf Abdallah 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 1 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 22 Sep 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?
Contact Mohamed As Abdallah (00201022677132, mohamedkhamis657@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
american shoulder elbow score (time frame: after 6months and 12 months). 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 22 Sep 2023.