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Completed

NCT Number: NCT04766905

Mini Lateral Shoulder Approach

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

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Key information

Age range

16 year–73 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Sayed Issa's Clinic

Aleppo, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mini Lateral Shoulder Approach (MLSA)

Procedure

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.

Other names: Second Sayed Issa's Approach

Primary outcomes

  1. Less surgical procedure time than traditional approaches

    Time frame: up to two years

    25 minutes to 45 minutes, it's depends of rotator cuff tear if exist or not.

  2. Less rehabilitation time than traditional approaches

    Time frame: up to two years

    6 - 8 weeks

  3. Passive physiotherapy immediately

    Time frame: up to two years

    next day of surgery

  4. Active physiotherapy without rotator cuff tear

    Time frame: up to two years

    after two weeks of surgery

  5. Mini cosmetic incision to the shoulder

    Time frame: up to two years

    4 - 5 cm

  6. Active physiotherapy with rotator cuff tear

    Time frame: up to two years

    after three weeks of surgery

Secondary outcomes

  1. very good patients satisfaction

    Time frame: up to two years

    after 8 weeks

  2. Restore deltoid muscle strength

    Time frame: up to two years

    about 3 months after surgery

Sponsors and collaborators

Lead sponsor

Issa, Abdulhamid Sayed, M.D.

Indiv

Registry information

Acronym: MLSA

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 23, 2021
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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