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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
44
Calcaneus Displacement Osteotomy using two metallic screws
Calcaneus Displacement Osteotomy using two bio-integrative screws
Departament of Orthopaedics and Rehabilitation, University of Iowa, Carver College of Medicine
Iowa City, Iowa, United States
RECRUITINGBone healing
\- Amount of bone bridging crossing the osteotomy site: Determined by the percentage of bone trabeculae crossing the osteotomy site on every tomography cut (amount of the cut in millimeters that shows bone spanning the two fragments divided by the total amount of osteotomy's surface on the cut). \- Weight-bearing computed tomography (WBCT) acquisitions will be used to determine this percentage.
Time frame: 6 weeks
Complications
\- Percentage of minor and major complications: Dehiscence: inability to heal the soft tissue coverage until the end of the 4th post-operative week. Peripherical nerve damage: hypoesthesia or paresthesia not solved until the 6th week after the surgery. Infection: clinical signs of site infection or pus drainage at the wound that required antibiotics.
Time frame: 6 weeks
Implant-related artifact
\- Quantity of Hounsfield units around the implants Measured on WBCT acquisitions.
Time frame: 6 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.