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Comparative study of the surgical treatment of Irreparable rotator cuff tears by the Augmentation associated with Interposition technique with fascia lata autograft versus Partial repair

Comparative study of the surgical treatment of Irreparable rotator cuff tears by the Augmentation associated with Interposition technique with fascia lata autograft versus Partial repair - ASES = American Shoulder and Elbow UCLA= University of California at Los Angeles

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6hywzn
Enrollment
Unknown
Registered
2018-09-17
Start date
2018-02-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Impingement Syndrome

Interventions

43 patients will be randomized into 2 groups by randomization by the randomization application irandomizer. Each group will undergo a type of surgery: group 1 with 23 patients (arthroscopic surgery of
group 2 with 20 patients (open surgery, mini-open type, augmentation and interposition, with autograft of fascia lata). Surgeries will be performed by the same surgical team, with experience in rotato
Q65.070
A02.340.424

Sponsors

Instituto de Assistência Médica ao Servidor Público Estadual de São Paulo - SP- IAMSPE
Lead Sponsor
Instituto de Assistência Médica ao Servidor Público Estadual de São Paulo - SP- IAMSPE
Collaborator

Eligibility

Age
50 Years to No maximum

Inclusion criteria

Inclusion criteria: Age above 50 years; complex rotator cuff lesion (extensive and massive) diagnosed by radiographs, MRI and clinical examination; rotator cuff injury without history of traumatic event; pain and / or decreased shoulder strength for at least 3 months without improvement with conservative treatment; cooperative patients, who agree to participate in the research and sign the consent form.

Exclusion criteria

Exclusion criteria: Previous surgeries in the studied shoulder; patients smokers, chronic alcoholics, diabetics and non-collaborative; advanced arthrosis or arthropathy; rheumatological diseases or chronic use of corticosteroids; psychiatric disorders, fibromyalgia or chronic cervicobrachialgia; active infections; blood dyscrasias; neurological or vascular diseases in the affected limb; clinically decompensated comorbidities; hyperlipidemia and advanced osteoporosis.

Design outcomes

Primary

MeasureTime frame
Comparative clinical functional assessment by the UCLA scale of patients operated on in both study groups. (0-35 pontos)

Secondary

MeasureTime frame
Comparative clinical functional assessment by the ASES scale of patients operated on in both study groups. (0-100 points);Comparative clinical functional assessment by the EVA of patients operated on in both study groups. (0-10 points);Comparative clinical evaluation by the range of active shoulder movement (frontal flexion, lateral rotation and medial rotation) of patients operated on in both study groups. (frontal flexion = 0-180 degrees measured with a goniometer); (lateral rotation = 0-90 degrees measured with a goniometer); (medial rotation = 0-10 points according to the reach of the hand in the dorsal region of the chest);Comparative clinical evaluation of the frontal flexion strength of the operated shoulder using a dynamometer of operated patients in both study groups. (average of 3 consecutive strength measurements = measured in kilograms);Comparative clinical evaluation of the occurrence of complications in operated patients in both study groups.;Comparative clinical functional assessment by the CONSTANT scale of patients operated on in both study groups. (0-100 points);Comparative radiological evaluation by analyzing the MRI scan of the shoulder of operated patients in both study groups. (image analysis by Sugaya's classification into 2 types = re-breaking or intact)

Countries

Brazil

Contacts

Public ContactFabiano Ribeiro

IAMSPE

fabianoreboucas@globo.com5511956063636

Outcome results

None listed

Source: REBEC (via WHO ICTRP)