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Clinical Trial Summary

The use of bio-integrative implants in orthopedic surgery is growing exponentially. As many biomechanical and histological studies were able to sustain its structural and biological properties, few clinical studies are available to support its advantages, such as good osteosynthesis, lower rates of removal, and diminished implant-related artifact in imaging studies. This information is vital to providers when choosing the proper material and planning postoperative treatment. This trial intends to test the capacity of the bioabsorbable screws in reaching the same clinical and radiographical outcomes of the current metallic screws.


Clinical Trial Description

A minimum of 44 patients undergoing Medial or Lateral Displacement Calcaneal Osteotomy (MDCO) will be randomized in two parallel groups for surgery, considering applied the implant. One group will be operated using two 4.0mm cannulated bio-integrative (absorbable) screws, and the other group using two 4.0mm cannulated metallic screws. Patients will be blinded evaluated for a mean follow-up of twelve weeks in terms of bone healing, complications, and implant-related artifact using weight-bearing computed tomography (WBCT). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05018130
Study type Interventional
Source University of Iowa
Contact Nacime Salomao Barbachan Mansur, MD, PhD
Phone 3194007911
Email nacime-mansur@iowa.edu
Status Recruiting
Phase N/A
Start date November 1, 2021
Completion date December 1, 2024

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