CompletedNot Applicable

Arthroscopic Trans-osseous Rotator-Cuff Repair Using the Giant-Needle and Grand-Knot Technique.

Egypt160 participantsStarted 2021-01-01

Plain-language summary

The purpose of this study is to compare a novel, cost-effective arthroscopic trans-osseous rotator cuff repair technique, known as the 'Grand-Knot' technique, against the standard repair using all-suture anchors. The study evaluates which method provides better functional recovery and structural healing for patients with full-thickness supraspinatus tears. Patients were randomized to receive either the Grand-Knot repair or the standard anchor repair and were followed for a minimum of 2.5 years to assess shoulder function using the ASES score, range of motion, and tendon integrity."

Who can participate

Age range45 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged 45 to 75 years. Diagnosis of full-thickness supraspinatus or posterosuperior rotator-cuff tears. Tears suitable for arthroscopic repair. Confirmation of diagnosis and tear morphology via standardized clinical examination and MRI. Willingness to comply with a 2.5-year follow-up protocol and standardized rehabilitation. Exclusion Criteria: * Partial-thickness tears or isolated subscapularis tears. Advanced fatty infiltration (Fuchs grade 3-4). Rotator cuff arthropathy (Hamada classification \> 2). Presence of calcific tendinitis in the affected shoulder. Prior ipsilateral shoulder surgery. General medical contraindications to arthroscopy or general anesthesia. Inability to complete the follow-up or provide informed consent.

What they're measuring

American Shoulder and Elbow Surgeons ASES Score

Timeframe: 30 months (2.5 years) postoperatively

Trial details

NCT IDNCT07327437

SponsorSherif Hamdy Zawam

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-01