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Bio-Integrative Versus Metallic Screws for Calcaneus Osteotomies

NCT05018130 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2023-09-06

No results posted yet for this study

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.

Conditions

  • Flatfoot
  • Bone Resorption
  • Cavus Deformity
  • Osteolysis
  • Complication

Interventions

PROCEDURE

Calcaneus Osteotomy (Metallic)

Calcaneus Displacement Osteotomy using two metallic screws

PROCEDURE

Calcaneus Osteotomy (Bio-integrative)

Calcaneus Displacement Osteotomy using two bio-integrative screws

Sponsors & Collaborators

  • University of Iowa

    lead OTHER

Principal Investigators

  • Nacime Salomao Barbachan Mansur · Visiting Associate

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2024-07-30
Completion
2024-12-01

Countries

  • United States

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 NCT05018130 on ClinicalTrials.gov