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

Not Applicable

• Conditions: Shoulder Impingement Syndrome; Transplantation, Autologous; Fascia Lata; Randomized Controlled Trial; C26.761.340

• Registration Number: RBR-6hywzn
• Lead Sponsor: Instituto de Assistência Médica ao Servidor Público Estadual de São Paulo - SP- IAMSPE

Brief Summary

INTRODUCTION: Biological adjuvants aim to reduce the incidence of retears and improve the functional results in the surgical treatment of extensive, massive, and irreparable rotator cuff tears, especially by augmentation and interposition techniques. OBJECTIVES: Evaluate the clinical, functional, and radiological results of surgical treatment of irreparable rotator cuff tears with augmentation associated with interposition technique by open approach, using fascia lata autograft comparing to partial arthroscopic repair technique. METHODS: The following clinical, functional, and radiological outcomes were used: the University of California at Los Angeles (UCLA) scale (primary outcome), American Shoulder and Elbow Surgeons (ASES) scale, pain visual analogue scale (VAS) performed on preoperative, three, six and 12 months after surgery; the range of active movement performed on preoperative and 12 months after surgery; Constant-Murley (Constant) scale, frontal flexion strength, retear rate by magnetic resonance imaging analysis and the occurrence of complications assessed 12 months after the surgery (secondary outcomes). In this interventional, prospective, controlled, randomized, and blind study, two groups of patients named the graft group (n=20) and the control group (n=22), only cases with irreparable rotator cuff tear of the posterosuperior topography were included. The augmentation associated with interposition technique by open approach was performed in the graft group, using fascia lata autograft. The arthroscopic partial repair technique of the rotator cuff was performed in the control group. A significance level of 5% was considered for all comparisons. RESULTS: The UCLA scale showed similar results between groups during the follow-up period (p>0,05), with evolutionary improvement for each period (p<0,05). The ASES scale showed similar results between groups during the follow-up period (p>0,05), with an evolutionary improvement up to 6 months (p<0,001). The Constant scale showed better result in the graft group (p=0,036). The VAS presented better result in the graft group at 12 months (p=0,006), and both groups showed evolutionary improvement up to 3 months (p<0,001). The amplitude of frontal flexion showed similar results between groups (p>0,05), with evolutionary improvement (p<0,001). The amplitude of lateral rotation showed better result in the graft group (p<0,001), with evolutionary improvement only in the graft group (p<0,001). The amplitude of medial rotation showed better result in the graft group (p<0,001), with evolutionary improvement in both groups (p<0,05). The frontal flexion strength showed better results in the graft group (p<0,05). The incidence of retear showed a better result in the graft group (p=0,033). There were no complications. CONCLUSIONS: Surgical treatment of irreparable rotator cuff tear with augmentation associated with interposition technique by open approach, using fascia lata autograft, presented similar results according to the UCLA scale, ASES scale, frontal flexion amplitude and occurrence of complications, and better results by VAS, Constant scale, lateral and medial rotation amplitudes, frontal flexion strength, and retear rate, compared with partial arthroscopic repair technique.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-17
• Study Completion: 2021-02-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparative clinical functional assessment by the UCLA scale of patients operated on in both study groups. <br>(0-35 pontos)