Bio-Integrative Versus Metallic Screws for Calcaneus Osteotomies

NCT05018130 | Unknown

• 1 other identifier: 202106228
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Flatfoot; Bone Resorption; Cavus Deformity; Osteolysis; Complication

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (2)

• Complications

  6 weeks

• Implant-related artifact

  6 weeks

Study Arms (2)

Bio-integrative

EXPERIMENTAL

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)

Metallic

ACTIVE COMPARATOR

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)

Interventions

Calcaneus Osteotomy (Metallic) PROCEDURE

Calcaneus Displacement Osteotomy using two metallic screws

Metallic

Calcaneus Osteotomy (Bio-integrative) PROCEDURE

Calcaneus Displacement Osteotomy using two bio-integrative screws

Bio-integrative

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

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

Iowa City, Iowa, 52241, United States

RECRUITING

Related Publications (10)

• 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.

  PMID: 31375999 BACKGROUND

• 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.

  PMID: 35097414 BACKGROUND

• Daghino W, Bistolfi A, Aprato A, Masse A. Bioabsorbable implants in foot trauma surgery. Injury. 2019 Aug;50 Suppl 4:S47-S55. doi: 10.1016/j.injury.2019.01.016. Epub 2019 Jan 23.

  PMID: 30711319 BACKGROUND

• 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.

  PMID: 9116891 BACKGROUND

• 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.

  PMID: 23714938 BACKGROUND

• Partio N, Mattila VM, Maenpaa H. Bioabsorbable vs. titanium screws for first tarsometatarsal joint arthrodesis: An in-vitro study. J Clin Orthop Trauma. 2020 May-Jun;11(3):448-452. doi: 10.1016/j.jcot.2019.08.017. Epub 2019 Aug 28.

  PMID: 32405207 BACKGROUND

• Qi L, Chang C, Xin T, Xing PF, Tianfu Y, Gang Z, Jian L. Double fixation of displaced patella fractures using bioabsorbable cannulated lag screws and braided polyester suture tension bands. Injury. 2011 Oct;42(10):1116-20. doi: 10.1016/j.injury.2011.01.025. Epub 2011 Feb 22.

  PMID: 21345433 BACKGROUND

• 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.

  PMID: 29843766 BACKGROUND

• Zhang J, Xiao B, Wu Z. Surgical treatment of calcaneal fractures with bioabsorbable screws. Int Orthop. 2011 Apr;35(4):529-33. doi: 10.1007/s00264-010-1183-5. Epub 2011 Jan 5.

  PMID: 21207026 BACKGROUND

• Jones CP, Coughlin MJ, Shurnas PS. Prospective CT scan evaluation of hindfoot nonunions treated with revision surgery and low-intensity ultrasound stimulation. Foot Ankle Int. 2006 Apr;27(4):229-35. doi: 10.1177/107110070602700401.

  PMID: 16624210 BACKGROUND

MeSH Terms

Conditions

Flatfoot; Bone Resorption; Talipes Cavus; Osteolysis

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bone Diseases

Study Officials

• Nacime Salomao Barbachan Mansur

  Visiting Associate

  STUDY DIRECTOR

Central Study Contacts

Nacime Salomao Barbachan Mansur, MD, PhD

CONTACT

3194007911; nacime-mansur@iowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The evaluator doctor will not have access to the protocol test applied to each patient and the surgeries will be conducted by different physicians.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

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

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 24, 2021
• Study Start: November 1, 2021
• Primary Completion: July 30, 2024
• Study Completion: December 1, 2024
• Last Updated: September 6, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After the study's publication and for 10 years.
• Access Criteria: Reasonable request.

Locations

US (1)