Bio-Integrative Versus Metallic Screws for Calcaneus Osteotomies

Sponsor

University of Iowa (Other)

Overall Status

Recruiting

CT.gov ID

NCT05018130

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Flatfoot Bone Resorption Cavus Deformity Osteolysis Complication	Procedure: Calcaneus Osteotomy (Metallic) Procedure: Calcaneus Osteotomy (Bio-integrative)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, investigator-blinded, in parallel groups, two-arms, single-center, non-inferiority, clinical trial.Randomized, investigator-blinded, in parallel groups, two-arms, single-center, non-inferiority, clinical trial.

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

The evaluator doctor will not have access to the protocol test applied to each patient and the surgeries will be conducted by different physicians.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Jul 30, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Bone healing [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.

Secondary Outcome Measures

Complications [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.
Implant-related artifact [6 weeks]
- Quantity of Hounsfield units around the implants Measured on WBCT acquisitions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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.).