Comparing bio-integrative and metallic screws for foot surgery
Bio-Integrative Versus Metallic Screws for Calcaneus Osteotomies: A Non- Inferiority Randomized Clinical Trial
NA · University of Iowa · NCT05018130
This study tests if new bio-integrative screws work as well as traditional metallic screws for foot surgery in helping patients heal and avoid complications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Iowa (other) |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT05018130 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of bio-integrative screws compared to traditional metallic screws in patients undergoing calcaneal osteotomies. A total of 44 participants will be randomly assigned to receive either type of screw during their surgery. The study will assess outcomes related to bone healing, complications, and imaging artifacts over a follow-up period of twelve weeks. The goal is to determine if bio-integrative screws can achieve similar clinical results as metallic screws while potentially offering additional benefits.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with hindfoot malalignment symptoms lasting at least six months.
Not a fit: Patients with previous surgeries on the affected calcaneus or certain autoimmune and vascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing foot surgery.
How similar studies have performed: While there is growing interest in bio-integrative implants, few clinical studies have been conducted, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.).
Where this trial is running
Iowa City, Iowa
- Departament of Orthopaedics and Rehabilitation, University of Iowa, Carver College of Medicine — Iowa City, Iowa, United States (RECRUITING)
Study contacts
- Study coordinator: Nacime Salomao Barbachan Mansur, MD, PhD
- Email: nacime-mansur@iowa.edu
- Phone: 3194007911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Flatfoot, Bone Resorption, Cavus Deformity, Osteolysis, Complication, Bone Healing, Osteotomy, Calcaneus