Clinical trial NCT04766905: Mini Lateral Shoulder Approach
Official title: Mini Lateral Shoulder Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Impingement Syndrome
Rotator Cuff Tendinopathy
Adhesive Capsulitis and Frozen Shoulder Syndrome
Keywords: Shoulder
Shoulder approach
Lateral Shoulder approach
Shoulder impingement syndrome
Rotator cuff tendinopathy
Adhesive capsulitis
Frozen shoulder syndrome
Lead sponsor: Issa, Abdulhamid Sayed, M.D.
Sponsor class: INDIV
First posted: 2021-02-23
Enrollment: 28
Sex: ALL
Minimum age (years): 16
Maximum age (years): 73
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The incision is very useful and easy for the direct lateral shoulder joint exposure.

Detailed description: The skin incision is about 4 to 5 cm made by the distal acromial edge in sagittal plane, The dissection takes place slightly over the acromial edge proximally and over the origin of the acromial deltoid part (the middle part of deltoid origin) distally.

After clearly revealing the region of the medial deltoid origin on the acromion, the acromionic deltoid origin is skinned only; of the edge of the acromion, and that maybe accrued by electric knife pen or periosteal elevator, without exposure the clavicular deltoid origin in the front and the deltoid origin on the spine of scapula in the back, the origin of the acromial deltoid is distanced laterally and distally, where the lateral edge, the lower surface of the acromion, under acromial bursa and the rotator cuff are exposed clearly.

Throw this approach can be made acromioplasty and rotator cuff tears repair especially upper part of rotator cuff tear very easily.

For wound closure the acromionic deltoid origin is reattached to the acromial edge by long period synthetic absorbable sutures as PDS and PDO, or non absorbable sutures as Polyester suture, under skin and skin sutures are made.

Eligibility criteria: Inclusion Criteria:

* Patients presented with Shoulder Impingement Syndrome refractory to conservative treatment and local steroid injection
* Patients presented with Adhesive Capsulitis and Frozen Shoulder Syndrome refractory to conservative treatment and local steroid injection
* Patients without femur head immigration on X-ray
* Patients with injury for one month to six months maximum

Exclusion Criteria:

* Patients with femur head immigration on X-ray
* Patients with injury for more than six months
* Un controlled diabetes mellitus type 1 and 2
* Patients with non controlled Vascular hypertension
* Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
* Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
* Patients with history of Carpal Tunnel release surgery failure

Primary outcomes:
measure: Less surgical procedure time than traditional approaches
timeFrame: up to two years
measure: Less rehabilitation time than traditional approaches
timeFrame: up to two years
measure: Passive physiotherapy immediately
timeFrame: up to two years
measure: Active physiotherapy without rotator cuff tear
timeFrame: up to two years
measure: Mini cosmetic incision to the shoulder
timeFrame: up to two years
measure: Active physiotherapy with rotator cuff tear
timeFrame: up to two years
Secondary outcomes:
measure: very good patients satisfaction
timeFrame: up to two years
measure: Restore deltoid muscle strength
timeFrame: up to two years
Other outcomes:
Locations:
city: Aleppo
country: Syrian Arab Republic
facility: Dr. Sayed Issa's Clinic
Study officials:
References: