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Bio-Integrative Versus Metallic Screws for Calcaneus Osteotomies

Primary Purpose

Flatfoot, Bone Resorption, Cavus Deformity

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Calcaneus Osteotomy (Metallic)

Calcaneus Osteotomy (Bio-integrative)

About this trial

This is an interventional treatment trial for Flatfoot focused on measuring Bone Healing, Osteotomy, Calcaneus, Bio-integrative, Metallic, Screws

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.).

Sites / Locations

Departament of Orthopaedics and Rehabilitation, University of Iowa, Carver College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bio-integrative

Metallic

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Bone healing

- 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

- 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

- Quantity of Hounsfield units around the implants Measured on WBCT acquisitions.

Full Information

NCT ID

NCT05018130

First Posted

August 10, 2021

Last Updated

August 31, 2023

Sponsor

University of Iowa

1. Study Identification

Unique Protocol Identification Number

NCT05018130

Brief Title

Bio-Integrative Versus Metallic Screws for Calcaneus Osteotomies

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2021 (Actual)

Primary Completion Date

July 30, 2024 (Anticipated)

Study Completion Date

December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Iowa

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Flatfoot, Bone Resorption, Cavus Deformity, Osteolysis, Complication

Keywords

Bone Healing, Osteotomy, Calcaneus, Bio-integrative, Metallic, Screws

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

InvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bio-integrative

Arm Type

Experimental

Arm Description

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.

Arm Title

Metallic

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Calcaneus Osteotomy (Metallic)

Intervention Description

Calcaneus Displacement Osteotomy using two metallic screws

Intervention Type

Procedure

Intervention Name(s)

Calcaneus Osteotomy (Bio-integrative)

Intervention Description

Calcaneus Displacement Osteotomy using two bio-integrative screws

Primary Outcome Measure Information:

Title

Bone healing

Description

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Complications

Description

Time Frame

6 weeks

Title

Implant-related artifact

Description

- Quantity of Hounsfield units around the implants Measured on WBCT acquisitions.

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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.).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nacime Salomao Barbachan Mansur, MD, PhD

Phone

3194007911

nacime-mansur@iowa.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nacime Salomao Barbachan Mansur

Organizational Affiliation

Visiting Associate

Official's Role

Study Director

Facility Information:

Facility Name

Departament of Orthopaedics and Rehabilitation, University of Iowa, Carver College of Medicine

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52241

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nacime Mansur, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

31375999

Citation

Acar B, Kose O, Unal M, Turan A, Kati YA, Guler F. Comparison of magnesium versus titanium screw fixation for biplane chevron medial malleolar osteotomy in the treatment of osteochondral lesions of the talus. Eur J Orthop Surg Traumatol. 2020 Jan;30(1):163-173. doi: 10.1007/s00590-019-02524-1. Epub 2019 Aug 2.

Results Reference

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PubMed Identifier

35097414

Citation

Cicchinelli LD, Stalc J, Richter M, Miller S. Prospective, Multicenter, Clinical and Radiographic Evaluation of a Biointegrative, Fiber-Reinforced Implant for Proximal Interphalangeal Joint Arthrodesis. Foot Ankle Orthop. 2020 Nov 27;5(4):2473011420966311. doi: 10.1177/2473011420966311. eCollection 2020 Oct.

Results Reference

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PubMed Identifier

30711319

Citation

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Results Reference

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PubMed Identifier

9116891

Citation

Hovis WD, Bucholz RW. Polyglycolide bioabsorbable screws in the treatment of ankle fractures. Foot Ankle Int. 1997 Mar;18(3):128-31. doi: 10.1177/107110079701800303.

Results Reference

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PubMed Identifier

23714938

Citation

Park S, Kim JH, Kim IH, Lee M, Heo S, Kim H, Kim EH, Choy YB, Heo CY. Evaluation of poly(lactic-co-glycolic acid) plate and screw system for bone fixation. J Craniofac Surg. 2013 May;24(3):1021-5. doi: 10.1097/SCS.0b013e31827fee09.

Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

21345433

Citation

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Citation

Tanner MC, Heller R, Westhauser F, Miska M, Ferbert T, Fischer C, Gantz S, Schmidmaier G, Haubruck P. Evaluation of the clinical effectiveness of bioactive glass (S53P4) in the treatment of non-unions of the tibia and femur: study protocol of a randomized controlled non-inferiority trial. Trials. 2018 May 30;19(1):299. doi: 10.1186/s13063-018-2681-9.

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Citation

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Citation

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Bio-Integrative Versus Metallic Screws for Calcaneus Osteotomies

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