Bio-Integrative Versus Metallic Screws for Calcaneus Osteotomies

University of Iowa

Status: Enrolling

Conditions: Osteolysis; Complication; Cavus Deformity; Flatfoot; Bone Resorption

Treatments: Procedure: Calcaneus Osteotomy (Metallic); Procedure: Calcaneus Osteotomy (Bio-integrative)

Study type: Interventional

Funder types: Other

Identifiers

NCT05018130

202106228

Details and patient eligibility

About

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.

Full 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).

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups

Bio-integrative

Experimental group

Description:

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.

Treatment:

Procedure: Calcaneus Osteotomy (Bio-integrative)

Metallic

Active Comparator group

Description:

Traditional oblique calcaneus osteotomy through a lateral approach. After a 10mm displacement, the osteotomy will be fixed with two 4.0mm metallic cannulated screws.

Treatment:

Procedure: Calcaneus Osteotomy (Metallic)