RECRUITING

Bio-Integrative Versus Metallic Screws for Calcaneus Osteotomies

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-11-01
Study Completion:2024-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05018130

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.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals must be older than 18 and younger than 75 years of age, both genders;
  2. * Participants must be experiencing symptoms related to their baseline condition for at least six months before the surgery;
  3. * Clinical diagnosis of hindfoot malignment, defined as the presence of a clinical hindfoot angle above 10 degrees of valgus or any degree of varus;
  4. * Surgical planning, including a calcaneus displacement osteotomy through a traditional oblique cut.
  1. * Previous surgery involving the affected calcaneus;
  2. * History or documented evidence of autoimmune or peripheral vascular diseases;
  3. * History or documented evidence of peripheral neuropathy (nervous compression syndrome, tarsal tunnel syndrome) or systemic inflammatory disease a (rheumatoid arthritis, spondylitis, Reiter Syndrome, etc.);
  4. * Any condition that represents a contraindication of the proposed therapies;
  5. * Impossibility or incapacity to sign the informed Consent Form;
  6. * Presence of infectious process (superficial on the skin and cellular tissue, or deep in the bone) in the region to be treated.
  7. * Osteotomies requiring resection of wedges (Dweyer, triple Dweyer, etc.);
  8. * Osteotomies planned to occur in a non-traditional cut (Malerba, Scarf, etc.).

Contacts and Locations

Study Contact

Nacime Salomao Barbachan Mansur, MD, PhD
CONTACT
3194007911
nacime-mansur@iowa.edu

Principal Investigator

Nacime Salomao Barbachan Mansur
STUDY_DIRECTOR
Visiting Associate

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Iowa

  • Nacime Salomao Barbachan Mansur, STUDY_DIRECTOR, Visiting Associate

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-01
Study Completion Date2024-12-01

Study Record Updates

Study Start Date2021-11-01
Study Completion Date2024-12-01

Terms related to this study

Keywords Provided by Researchers

  • Bone Healing
  • Osteotomy
  • Calcaneus
  • Bio-integrative
  • Metallic
  • Screws

Additional Relevant MeSH Terms

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