Bio-Integrative Versus Metallic Screws for Calcaneus Osteotomies

Description

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

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Study Overview

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Study Details

Study overview

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.

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

Bio-Integrative Versus Metallic Screws for Calcaneus Osteotomies

Condition
Flatfoot
Intervention / Treatment

-

Contacts and Locations

Iowa City

Departament of Orthopaedics and Rehabilitation, University of Iowa, Carver College of Medicine, Iowa City, Iowa, United States, 52241

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * Previous surgery involving the affected calcaneus;
  • * History or documented evidence of autoimmune or peripheral vascular diseases;
  • * History or documented evidence of peripheral neuropathy (nervous compression syndrome, tarsal tunnel syndrome) or systemic inflammatory disease a (rheumatoid arthritis, spondylitis, Reiter Syndrome, etc.);
  • * Any condition that represents a contraindication of the proposed therapies;
  • * Impossibility or incapacity to sign the informed Consent Form;
  • * Presence of infectious process (superficial on the skin and cellular tissue, or deep in the bone) in the region to be treated.
  • * Osteotomies requiring resection of wedges (Dweyer, triple Dweyer, etc.);
  • * Osteotomies planned to occur in a non-traditional cut (Malerba, Scarf, etc.).

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Iowa,

Nacime Salomao Barbachan Mansur, STUDY_DIRECTOR, Visiting Associate

Study Record Dates

2024-12-01