Recruiting

Bio-Integrative & Metallic Screws

Sponsor:

University of Iowa

Code:

NCT05018130

Conditions

Flatfoot

Bone Resorption

Cavus Deformity

Osteolysis

Complication

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Calcaneus Osteotomy (Metallic)

Calcaneus Osteotomy (Bio-integrative)

Study Details

Brief 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

Study ID

NCT05018130

Start date

Nov 1, 2021

Status verified date

Aug, 2023

Completion date

Dec 1, 2024

Anticipated

Primary completion date

Jul 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion 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.

Exclusion Criteria:

  • 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.).

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Calcaneus Osteotomy (Metallic)

Calcaneus Displacement Osteotomy using two metallic screws

Calcaneus Osteotomy (Bio-integrative)

Calcaneus Displacement Osteotomy using two bio-integrative screws

Primary outcome measure

  • Bone healing [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Nacime Salomao Barbachan Mansur, MD, PhD

3194007911nacime-mansur@iowa.edu

Locations

Departament of Orthopaedics and Rehabilitation, University of Iowa, Carver College of Medicine

Recruiting

Iowa City, Iowa, United States, 52241

More Information

Sponsor

University of Iowa

Last update posted

Sep 6, 2023

Last verified

Aug, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Iowa on 2023-09-06.