Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06242158 |
| Other study ID # |
MS-518-2019 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 19, 2019 |
| Est. completion date |
December 30, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
Kasr El Aini Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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
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.
