Bio-Integrative Versus Metallic Screws for Calcaneus Osteotomies

NCT ID: NCT05018130

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2024-12-01

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.

Detailed Description

A minimum of 44 patients undergoing Medial or Lateral Displacement Calcaneal Osteotomy (MDCO) will be randomized in two parallel groups for surgery, considering applied the implant. One group will be operated using two 4.0mm cannulated bio-integrative (absorbable) screws, and the other group using two 4.0mm cannulated metallic screws. Patients will be blinded evaluated for a mean follow-up of twelve weeks in terms of bone healing, complications, and implant-related artifact using weight-bearing computed tomography (WBCT).

Conditions

Flatfoot; Bone Resorption; Cavus Deformity; Osteolysis; Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Calcaneus Osteotomy (Bio-integrative)

Intervention Type: PROCEDURE

Calcaneus Displacement Osteotomy using two bio-integrative screws

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.

Group Type: ACTIVE_COMPARATOR

Calcaneus Osteotomy (Metallic)

Intervention Type: PROCEDURE

Calcaneus Displacement Osteotomy using two metallic screws

Interventions

Calcaneus Osteotomy (Metallic)

Calcaneus Displacement Osteotomy using two metallic screws

Intervention Type: PROCEDURE

Calcaneus Osteotomy (Bio-integrative)

Calcaneus Displacement Osteotomy using two bio-integrative screws

Intervention Type: PROCEDURE

Eligibility Criteria

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.).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

John Femino

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nacime Salomao Barbachan Mansur

Role: STUDY_DIRECTOR

Visiting Associate

Locations

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

Iowa City, Iowa, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nacime Salomao Barbachan Mansur, MD, PhD

Role: CONTACT

nacime-mansur@iowa.edu

3194007911

Facility Contacts

Nacime Mansur, MD, PhD

Role: primary

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Other Identifiers

202106228

Identifier Type: -

Identifier Source: org_study_id