Clinical trial NCT05018130: 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
Overall status: RECRUITING
Phase: NA
Conditions: Flatfoot
Bone Resorption
Cavus Deformity
Osteolysis
Complication
Keywords: Bone Healing
Osteotomy
Calcaneus
Bio-integrative
Metallic
Screws
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, investigator-blinded, in parallel groups, two-arms, single-center, non-inferiority, clinical trial.
Primary purpose: TREATMENT

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).

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.).

Primary outcomes:
measure: Bone healing
timeFrame: 6 weeks
Secondary outcomes:
measure: Complications
timeFrame: 6 weeks
measure: Implant-related artifact
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Departament of Orthopaedics and Rehabilitation, University of Iowa, Carver College of Medicine
state: Iowa
Study officials:
affiliation: Visiting Associate
name: Nacime Salomao Barbachan Mansur
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.