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Comparison of Uncemented and Hybrid Hip Arthroplasty: Protocol for a Brazilian Randomized Controlled Trial
Bruno Gonçalves Schroder E Souza1, Isabella Dias Lacerda1, Matheus Malta Vasconcelos1
1Faculdade de Ciências Médicas e da Saúde de Juiz de Fora - Suprema, Alameda Salvaterra, 200, Juiz de Fora, 36033-003, Brazil, 55 (32) 3211-0012.
Background:
Total hip arthroplasty is a highly successful procedure for treating hip arthritis, improving patients' pain, function, and quality of life (QoL). Scarce publications on total hip arthroplasty performance using Brazilian-manufactured materials report results comparable to those from other countries.
Objective:
The aim of this study is to compare the clinical, radiographic, functional, pain, and QoL outcomes of patients who underwent surgery with a national hybrid prosthesis (with femoral cementation) versus patients who underwent surgery with a national uncemented prosthesis.
Methods:
This study is a single-center, single-surgeon, single-approach, pragmatic, double-blinded, and prospective randomized trial. A total of 120 patients will be enrolled and randomly allocated in a 1:1 ratio to 2 groups: the hybrid group and the uncemented group. The incidence of complications (during and after surgery) and the restoration of normal anatomical parameters on postoperative radiographs will be assessed using radiographic parameters. Participants' QoL, joint mobility, function, and satisfaction will be evaluated using the 12-Item Short Form Health Survey version 2 questionnaire, hip range of motion, the Harris Hip Score, and a numeric rating scale. Prosthesis survival will be analyzed using the annual revision surgery rate from 1 to 5 years, and up to 10 years.
Results:
The project did not receive external funding. Data collection began in October 2024 and is ongoing, with completion expected in December 2029. As of April 2025, 72 participants have been enrolled. Preliminary data analysis has been initiated and is ongoing. The first results are expected to be published in the first half of 2026.
Conclusions:
This study is a pragmatic clinical trial that uses blinding to evaluate national implants for both hybrid and uncemented hip arthroplasty. Successful completion of this study may provide clinical evidence on the performance of national implants and identify a preferred implant construct (hybrid or uncemented), if any, for hip replacement in Brazil.
