Bio-Integrative Versus Metallic Screws for Calcaneus Osteotomies

August 31, 2023 updated by: John Femino, University of Iowa

Bio-Integrative Versus Metallic Screws for Calcaneus Osteotomies: A Non- Inferiority Randomized Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52241
        • Recruiting
        • Departament of Orthopaedics and Rehabilitation, University of Iowa, Carver College of Medicine
        • Contact:
          • Nacime Mansur, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bio-integrative
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.
Procedure: Calcaneus Osteotomy (Bio-integrative)
Calcaneus Displacement Osteotomy using two bio-integrative screws
Active Comparator: Metallic
Traditional oblique calcaneus osteotomy through a lateral approach. After a 10mm displacement, the osteotomy will be fixed with two 4.0mm metallic cannulated screws.
Procedure: Calcaneus Osteotomy (Metallic)
Calcaneus Displacement Osteotomy using two metallic screws

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone healing
Time Frame: 6 weeks

- 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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 6 weeks

- 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.
6 weeks
Implant-related artifact
Time Frame: 6 weeks

- Quantity of Hounsfield units around the implants

Measured on WBCT acquisitions.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Iowa

Investigators

  • Study Director: Nacime Salomao Barbachan Mansur, Visiting Associate

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Estimated)

July 30, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 10, 2021

First Submitted That Met QC Criteria

August 17, 2021

First Posted (Actual)

August 24, 2021

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

August 31, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202106228

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Nonidentified data will be shared to researchers upon request.

IPD Sharing Time Frame

After the study's publication and for 10 years.

IPD Sharing Access Criteria

Reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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