Bio-Integrative Versus Metallic Screws for Calcaneus Osteotomies

Launched by UNIVERSITY OF IOWA · Aug 17, 2021

Keywords

ClinConnect Summary

This clinical trial is comparing two types of screws used in surgery for foot conditions, specifically bio-integrative screws (which are made to dissolve in the body) and traditional metallic screws. The goal is to see if the bio-integrative screws work just as well as the metallic ones in helping to fix conditions like flatfoot and other deformities of the foot, which can cause pain and mobility issues. The trial will look at how well the screws help heal the foot and whether there are any differences in recovery.

To participate in the trial, individuals need to be between 18 and 75 years old and have been experiencing foot problems for at least six months. They should have a specific foot alignment issue that can be treated with a particular type of surgery. Unfortunately, those who have had previous surgeries on the same foot, certain medical conditions, or infections in the area cannot join. Participants can expect to undergo surgery and will help researchers understand which type of screw is more beneficial for healing. This information could potentially improve treatment options for many patients in the future.

Gender

ALL

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.).