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Cost-Effectiveness of Rotator Cuff Repair Methods

NCT04146987 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-10-14

No results posted yet for this study

Summary

Shoulder pain is one of the most common musculoskeletal complaints in orthopedic practice. Rotator cuff injuries account for up to 70% of pain in the shoulder girdle. There is no clinical study carried out in Brazil comparing cost effectiveness between the open and arthroscopic methods of rotator cuff repair surgery.

The present study aims to determine which method of repair of the rotator cuff, open or arthroscopic, has the best cost effectiveness ratio.

A randomized clinical trial will be carried out in which patients with symptomatic rotator cuff lesion will be submitted to repair surgery by either open or arthroscopic technique and will be subsequently evaluated.

Conditions

  • Rotator Cuff Injuries
  • Shoulder Pain
  • Shoulder Impingement
  • Shoulder Injuries
  • Shoulder Bursitis
  • Shoulder Tendinitis
  • Shoulder Lesions

Interventions

PROCEDURE

Rotator cuff repair surgery

Patients will undergo open rotator cuff repair or arthroscopic rotator cuff repair

Sponsors & Collaborators

  • Hospital Alvorada

    collaborator OTHER

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • Hospital Israelita Albert Einstein

    lead OTHER

Principal Investigators

  • Rafael Pierami, MD · SOCIEDADE BENEF ISRAELITABRAS HOSPITAL ALBERT EINSTEIN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2022-11-01
Completion
2022-12-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04146987 on ClinicalTrials.gov