Bio-Integrative Versus Metallic Screws for Calcaneus Osteotomies

Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05018130
• Other study ID #: 202106228
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: August 2023
• Source: University of Iowa
• Contact: Nacime Salomao Barbachan Mansur, MD, PhD
• Phone: 3194007911
• Email: nacime-mansur[@]iowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 1, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Bone Resorption
• Complication
• Flatfoot
• Osteolysis

Intervention

Procedure:
• Calcaneus Osteotomy (Metallic)
Calcaneus Displacement Osteotomy using two metallic screws
• Calcaneus Osteotomy (Bio-integrative)
Calcaneus Displacement Osteotomy using two bio-integrative screws

Locations

Country	Name	City	State
United States	Departament of Orthopaedics and Rehabilitation, University of Iowa, Carver College of Medicine	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View Citation

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. — View 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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	6 weeks
Secondary	Implant-related artifact	- Quantity of Hounsfield units around the implants; Measured on WBCT acquisitions.	6 weeks