Clinical trial NCT06242158: 5 Step Mini-open Method of Massive Rotator Cuff Repair
Official title: The 5-step Mini-open Method of Massive Rotator Cuff Repair and Clinical and Radiological Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Massive Rotator Cuff Tears
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 48
Sex: ALL
Minimum age (years): 60
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: These are patients who presented to cairo university hospitals between 2019 and 2023

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Osteoarthritis
* associated fractures
* younger than 60 orolder than 84

Primary outcomes:
measure: Constant score
timeFrame: (Pre operative) then at post operative 1 year and 2 years
Secondary outcomes:
measure: Vas score
timeFrame: (Pre operative) then at post operative 1 year and 2 years
measure: UCLA score
timeFrame: (Pre operative) then at post operative 1 year and 2 years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy Hospital - Faculty of Medicine - Cairo University
Study officials:
References: