Massive Rotator Cuff TearsNCT06242158
5 Step Mini-open Method of Massive Rotator Cuff Repair
An observational study of Massive Rotator Cuff Tears, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
48 patients with massive rotator cuff tears were treated with a standardized five step technique of arthroscopic guided mini-open tranosseous repair with bursal augmentation. Their follow up is noted Read more about this study
- Who is it for?
- Ages 60 to 84 years
- Conditions the study is for
- Massive Rotator Cuff Tears
- What is being tested?
- arthroscopic assisted mini-open 5 step repair
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Sep 2019to 30 Dec 2023
- Phase
- Observational
- 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 60 to 84 years
- All sexes
- Adult, Older adult
Study population: These are patients who presented to cairo university hospitals between 2019 and 2023
Who may be able to join
- a case with massive rotator cuff tear that is repairable (judged intraoperative by arthroscope that the tear returns to its footprint)
- ages from 60 to 84
Who cannot join
- Osteoarthritis
- associated fractures
- younger than 60 orolder than 84
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kasr Alainy Hospital - Faculty of Medicine - Cairo University
Cairo, 11765
About this study
Official title: The 5-step Mini-open Method of Massive Rotator Cuff Repair and Clinical and Radiological Outcome
48 patients with massive rotator cuff tears were treated with a standardized five step technique of arthroscopic guided mini-open tranosseous repair with bursal augmentation. Their follow up is noted
Read the detailed description
48 patients with massive rotator cuff tears were treated with a standardized five-step technique of arthroscopic guided mini-opentranosseous repair with bursal augmentation . ( 22 ) males and ( 26 ) females. age had a range of (58-68 ) with a mean (of 61 ) . The rt side was involved in ( 22 ) the lt side was involved in (26 ) . (12 ) patients had diabetes while one was on dialysis.
All patients were evaluated clinically for the range of movements of the shoulder in foreword flexion, abduction, ext, and int rotation. The constant score and UCLA scores were used for functional evaluation. Patients with flexion less than 90% were included in the study.
Standard plain x-ray of the shoulder and MRI were performed for all patients to evaluate the CSA and the condition of the rotator cuff. Tears were considered Massive rotator cuff tears if two or more tendons were involved. The degree of fatty degeneration and retraction of the tendon was not a contraindication for repair.
Surgical approach The procedures were performed under general anesthesia in association with interscalene brachial plexus block. The patient was positioned on a beach chair and conventional portals were used for both glen humeral and subacromial space.
First step Identifying the tear size, quality, and if reducible on the footprint. minimal removal of the bursa and pulling of the tendon with a grasper to reach the footprint area with gentle tendon mobilization. if the tendon is of bad quality and friable with the application of the grasper or if it is nonreducible on the footprint we stop the procedure of repair and shift to tendon transfer.
Step two Acromioplasty with removing the anterior and lateral part of the acromion in type 2,3 so we can reach a wide space allowing the blunt trocher 4mm diameter to slide comfortably in different positions of shoulder abduction. minimal removal of coracoacrominalligement was done to prevent superior instability .mimimal removal of the fibers of the deltoid anterior to prevent detachment of the anterior fibers of the deltoid when performing anterior lateral mini-open approach.
Using a probe, the LHBT was palpated and mobilized, looking for any signs of degeneration and fraying or instability. The LHBT was inspected either through the subacromial portal tear or the glenohumeral portal.
For patients aged 65 years or older, a tenotomy was performed. Tenodesis was performed on younger and active patients. Tenotomy was performed close to the origin of the glenoid labrum. Tenodesis, when indicated, was performed using fixing nonabsorbable sutures to the insertion pectoralis tendon by a separate incision.
Lastely the footprint is prepared at a slow speed bear with special consideration to localize and prepare the whole length and breadth of the footprint.
Step three Antero-lateral mini-open approach was used through a longitudinal 4 cm skin incision in line with anterior acromion and splitting the anterolateral raphe of the deltoid muscle between the anterior and middle fibers. A blunt deltoid retractor was applied and involvement and configuration of the torn tendon was confirmed by rotating the arm and attempting anatomical reduction on the footprint. A Cobb dissector was used to further mobilize the tendon passing deep under the acromion and pushing gently the rotator tendon to the outside towards the greater tuberosity bone Step four Transosseous repair using the giant needle was used. 3 to 4 number two fiber wire sutures were passed equidistance through the tendon (fig ). The giant needle was introduced to penetrate the bone at equidistance of the footprint and emerged from the skin about 5 cm from the tip of the greater tuberosity. A right angle hook was used superficially to the bursa to retrieve the distance end of the sutures. Before tightening the sutures the subacrominal bursa was mobilized gently from medial and posterior towards the tendon ends.
Step five The subacromial bursa was used for biological augmentation of the repair by overlapping the site of repair of the tendon to the bone. This was done by applying the sliding knot involving both the bursa and the tendon. Tighting the sutures pulls the tendon down on the bone and overlaps the bursa on the healing sight (fig ).
Post-operative The patient Weard an abduction brace and began pendulum and passive range-of-motion exercises one day after surgery. They began active range-of-motion exercises six weeks after surgery, muscle-strengthening exercises at three months, and occupational or sports activities at six months.
- Conditions
- Massive Rotator Cuff Tears
- Being tested
- arthroscopic assisted mini-open 5 step repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthroscopic assisted mini-open 5 step repairProcedure or surgery
First step Identifying the tear size , quality and if reducible on the foot print . minimal removal of the bursa and pulling of the tendon with a grasper to reach the foot print area with gentle mobilization of the tendon .
Step two Acromioplasty Using a probe, the LHBT was palpated and mobilized, looking for any signs of degeneration and fraying or instability . The LHBT was inspected either through the tear by the subacrominal portal or through the glenohumeral portal .
Step three Antero-lateral mini-open approach was used through a longitudinal 4 cm skin incision Step four Transosseous repair using the giant needle was used. 3 to 4 number two fiber wire sutures was passed equidistance through the tendon Step five The subarominal bursa was used for biological augmentation of the repair
| Study group | Role | What they receive |
|---|---|---|
| Case with massive rotator cuff tear | Case with massive rotator cuff tear defined as more than 2 complete tendon tear that is repairable Receives: Procedure: arthroscopic assisted mini-open 5 step repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant score
for function of shoulder
Measured: (Pre operative) then at post operative 1 year and 2 years
Secondary outcomes (2)
Vas score
for pain
Measured: (Pre operative) then at post operative 1 year and 2 years
UCLA score
for function
Measured: (Pre operative) then at post operative 1 year and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start19 Sep 2019
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Massive Rotator Cuff TearsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Omar Sabry, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242158
- Sponsor's protocol ID
- MS-518-2019
- Status last verified
- Jan 2024
- First submitted
- 27 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 5-step Mini-open Method of Massive Rotator Cuff Repair and Clinical and Radiological Outcome
- ClinicalTrials.gov ID
- NCT06242158
- Acronym / sponsor ID
- MS-518-2019
- Conditions
- Massive Rotator Cuff Tears
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 5 Feb 2024 (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.
48 patients with massive rotator cuff tears were treated with a standardized five step technique of arthroscopic guided mini-open tranosseous repair with bursal augmentation. Their follow up is noted
Detailed description
48 patients with massive rotator cuff tears were treated with a standardized five-step technique of arthroscopic guided mini-opentranosseous repair with bursal augmentation . ( 22 ) males and ( 26 ) females. age had a range of (58-68 ) with a mean (of 61 ) . The rt side was involved in ( 22 ) the lt side was involved in (26 ) . (12 ) patients had diabetes while one was on dialysis.
All patients were evaluated clinically for the range of movements of the shoulder in foreword flexion, abduction, ext, and int rotation. The constant score and UCLA scores were used for functional evaluation. Patients with flexion less than 90% were included in the study.
Standard plain x-ray of the shoulder and MRI were performed for all patients to evaluate the CSA and the condition of the rotator cuff. Tears were considered Massive rotator cuff tears if two or more tendons were involved. The degree of fatty degeneration and retraction of the tendon was not a contraindication for repair.
Surgical approach The procedures were performed under general anesthesia in association with interscalene brachial plexus block. The patient was positioned on a beach chair and conventional portals were used for both glen humeral and subacromial space.
First step Identifying the tear size, quality, and if reducible on the footprint. minimal removal of the bursa and pulling of the tendon with a grasper to reach the footprint area with gentle tendon mobilization. if the tendon is of bad quality and friable with the application of the grasper or if it is nonreducible on the footprint we stop the procedure of repair and shift to tendon transfer.
Step two Acromioplasty with removing the anterior and lateral part of the acromion in type 2,3 so we can reach a wide space allowing the blunt trocher 4mm diameter to slide comfortably in different positions of shoulder abduction. minimal removal of coracoacrominalligement was done to prevent superior instability .mimimal removal of the fibers of the deltoid anterior to prevent detachment of the anterior fibers of the deltoid when performing anterior lateral mini-open approach.
Using a probe, the LHBT was palpated and mobilized, looking for any signs of degeneration and fraying or instability. The LHBT was inspected either through the subacromial portal tear or the glenohumeral portal.
For patients aged 65 years or older, a tenotomy was performed. Tenodesis was performed on younger and active patients. Tenotomy was performed close to the origin of the glenoid labrum. Tenodesis, when indicated, was performed using fixing nonabsorbable sutures to the insertion pectoralis tendon by a separate incision.
Lastely the footprint is prepared at a slow speed bear with special consideration to localize and prepare the whole length and breadth of the footprint.
Step three Antero-lateral mini-open approach was used through a longitudinal 4 cm skin incision in line with anterior acromion and splitting the anterolateral raphe of the deltoid muscle between the anterior and middle fibers. A blunt deltoid retractor was applied and involvement and configuration of the torn tendon was confirmed by rotating the arm and attempting anatomical reduction on the footprint. A Cobb dissector was used to further mobilize the tendon passing deep under the acromion and pushing gently the rotator tendon to the outside towards the greater tuberosity bone Step four Transosseous repair using the giant needle was used. 3 to 4 number two fiber wire sutures were passed equidistance through the tendon (fig ). The giant needle was introduced to penetrate the bone at equidistance of the footprint and emerged from the skin about 5 cm from the tip of the greater tuberosity. A right angle hook was used superficially to the bursa to retrieve the distance end of the sutures. Before tightening the sutures the subacrominal bursa was mobilized gently from medial and posterior towards the tendon ends.
Step five The subacromial bursa was used for biological augmentation of the repair by overlapping the site of repair of the tendon to the bone. This was done by applying the sliding knot involving both the bursa and the tendon. Tighting the sutures pulls the tendon down on the bone and overlaps the bursa on the healing sight (fig ).
Post-operative The patient Weard an abduction brace and began pendulum and passive range-of-motion exercises one day after surgery. They began active range-of-motion exercises six weeks after surgery, muscle-strengthening exercises at three months, and occupational or sports activities at six months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case with massive rotator cuff tear | – | Procedure: arthroscopic assisted mini-open 5 step repairCase with massive rotator cuff tear defined as more than 2 complete tendon tear that is repairable |
Who may qualify
- Ages
- 60 to 84 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- These are patients who presented to cairo university hospitals between 2019 and 2023
Key inclusion criteria (2 listed)
- a case with massive rotator cuff tear that is repairable (judged intraoperative by arthroscope that the tear returns to its footprint)
- ages from 60 to 84
Key exclusion criteria (3 listed)
- Osteoarthritis
- associated fractures
- younger than 60 orolder than 84
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 assisted mini-open 5 step repairFirst step Identifying the tear size , quality and if reducible on the foot print . minimal removal of the bursa and pulling of the tendon with a grasper to reach the foot print area with gentle mobilization of the tendon . Step two Acromioplasty Using a probe, the LHBT was palpated and mobilized, looking for any signs of degeneration and fraying or instability . The LHBT was inspected either through the tear by the subacrominal portal or through the glenohumeral portal . Step three Antero-lateral mini-open approach was used through a longitudinal 4 cm skin incision Step four Transosseous repair using the giant needle was used. 3 to 4 number two fiber wire sutures was passed equidistance through the tendon Step five The subarominal bursa was used for biological augmentation of the repair | Procedure or surgery | Case with massive rotator cuff tear |
Primary outcome
Constant score
Time frame: (Pre operative) then at post operative 1 year and 2 years
for function of shoulder
2 secondary outcomes
Vas score
Time frame: (Pre operative) then at post operative 1 year and 2 years
UCLA score
Time frame: (Pre operative) then at post operative 1 year and 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Massive Rotator Cuff Tears, run by Kasr El Aini Hospital 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 3 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: finished, as of the sponsor's last update on 5 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Constant score (time frame: (Pre operative) then at post operative 1 year and 2 years). 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 5 Feb 2024.