NCT05018130

Bio-Integrative Versus Metallic Screws for Calcaneus Osteotomies

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Calcaneus Osteotomy (Metallic)	Calcaneus Displacement Osteotomy using two metallic screws
PROCEDURE	Calcaneus Osteotomy (Bio-integrative)	Calcaneus Displacement Osteotomy using two bio-integrative screws

Timeline

• Start date: 2021-11-01
• Primary completion: 2024-07-30
• Completion: 2024-12-01
• First posted: 2021-08-24
• Last updated: 2023-09-06

Locations

1 site across 1 country: United States