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Bioabsorbable Implant

Bio-Integrative vs Metallic Screws for Flatfoot Surgery

N/A

Recruiting

Led By Nacime Salomao Barbachan Mansur

Research Sponsored by University of Iowa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be experiencing symptoms related to their baseline condition for at least six months before the surgery

Clinical diagnosis of hindfoot malalignment, defined as the presence of a clinical hindfoot angle above 10 degrees of valgus or any degree of varus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

Study Summary

This trial is testing the effectiveness of bio-integrative implants, which are growing in popularity for orthopedic surgery.

Who is the study for?

This trial is for adults aged 18-75 with hindfoot malalignment, experiencing symptoms for at least six months. Candidates must be planning a calcaneus osteotomy using an oblique cut. Exclusions include inability to consent, infections in the treatment area, previous surgery on the affected foot, neuropathy or systemic inflammatory diseases.Check my eligibility

What is being tested?

The study compares bio-integrative screws versus metallic screws in foot surgeries (calcaneus osteotomies). It aims to evaluate if bioabsorbable screws can match metallic ones in clinical and radiographical outcomes post-surgery.See study design

What are the potential side effects?

While not explicitly listed, potential side effects may include typical surgical risks such as infection, pain at the implant site, inflammation around the screw area, and possible adverse reactions to materials used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had symptoms from my condition for at least 6 months before my surgery.

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My foot is misaligned, either angled outward more than 10 degrees or any inward angle.

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I am between 19 and 74 years old.

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I am scheduled for a specific foot surgery involving a bone cut.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Bone healing

Secondary outcome measures

Complications

Implant-related artifact

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Bio-integrativeExperimental Treatment1 Intervention

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.

Group II: MetallicActive Control1 Intervention

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of IowaLead Sponsor

446 Previous Clinical Trials

879,458 Total Patients Enrolled

Cesar de Cesar Netto, MD, PhDStudy DirectorAssistant Professor

Nacime Salomao Barbachan MansurPrincipal InvestigatorVisiting Associate

Media Library

Calcaneus Osteotomy (Bio-integrative) (Bioabsorbable Implant) Clinical Trial Eligibility Overview. Trial Name: NCT05018130 — N/A

Osteoporosis Research Study Groups: Bio-integrative, Metallic

Osteoporosis Clinical Trial 2023: Calcaneus Osteotomy (Bio-integrative) Highlights & Side Effects. Trial Name: NCT05018130 — N/A

Calcaneus Osteotomy (Bio-integrative) (Bioabsorbable Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05018130 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project admit participants who are 65 years old or over?

"To be included in this research, potential participants must fall within the age range of 18-85. The study is divided into 9 trials for those younger than 18 and 32 studies are available to patients over 65 years old."

Answered by AI

Are enrolments being taken for this medical study?

"Per the information listed on clinicaltrials.gov, this medical study is currently recruiting participants. This research was first announced to the public on November 1st 2021 and has since been updated as of November 19th 2022."

Answered by AI

What are the eligibility requirements for participating in this clinical study?

"This trial is seeking up to 44 individuals, aged 18-75, who have been diagnosed with bone resorption and accompanying symptoms for a minimum of 6 months before the surgery. Additionally, participants must demonstrate hindfoot malignment of valgus 10 degrees or greater or any degree of varus. The plan calls for calcaneal displacement osteotomy via an oblique cut."

Answered by AI

What is the size of the cohort participating in this clinical research?

"Affirmative. The clinical trial record on clinicialtrials.gov reveals that this medical research is currently recruiting members, having been initially posted on November 1st 2021 and recently updated as of November 19th 2022. Forty-four participants must be enrolled at a single location for the study to reach its goal."

Answered by AI