Bio-Integrative Versus Metallic Screws for Calcaneus Osteotomies: A Non- Inferiority Randomized Clinical Trial

Status: Unknown
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Individuals must be older than 18 and younger than 75 years of age, both genders;

• Participants must be experiencing symptoms related to their baseline condition for at least six months before the surgery;

• Clinical diagnosis of hindfoot malignment, defined as the presence of a clinical hindfoot angle above 10 degrees of valgus or any degree of varus;

• Surgical planning, including a calcaneus displacement osteotomy through a traditional oblique cut.

Locations
United States
Iowa
Departament of Orthopaedics and Rehabilitation, University of Iowa, Carver College of Medicine
RECRUITING
Iowa City
Contact Information
Primary
Nacime Salomao Barbachan Mansur, MD, PhD
nacime-mansur@iowa.edu
3194007911
Time Frame
Start Date: 2021-11-01
Completion Date: 2024-12-01
Participants
Target number of participants: 44
Treatments
Experimental: Bio-integrative
Traditional oblique calcaneus osteotomy through a lateral approach. After a 10mm displacement, the osteotomy will be fixed with two 4.0mm bio-integrative cannulated screws.
Active_comparator: Metallic
Traditional oblique calcaneus osteotomy through a lateral approach. After a 10mm displacement, the osteotomy will be fixed with two 4.0mm metallic cannulated screws.
Authors
Cesar de Cesar Netto
Sponsors
Leads: University of Iowa

This content was sourced from clinicaltrials.gov