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FlatfootNCT05018130

Bio-Integrative Versus Metallic Screws for Calcaneus Osteotomies

A study testing Calcaneus Osteotomy (Metallic) and Calcaneus Osteotomy (Bio-integrative) in people with Flatfoot and Bone Resorption, run by University of Iowa at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Flatfoot, Bone Resorption, Cavus Deformity
What is being tested?
Calcaneus Osteotomy (Metallic) and Calcaneus Osteotomy (Bio-integrative)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
1 Nov 2021to 1 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.).

Trial locations and contacts

1 site in 1 country.

Nacime Salomao Barbachan Mansur, MD, PhD contact

3194007911

nacime-mansur@iowa.edu

United States1 site, 1 recruiting

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

    Iowa City, Iowa, 52241

    Nacime Mansur, MD, PhD

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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).

Being tested
Calcaneus Osteotomy (Metallic), Calcaneus Osteotomy (Bio-integrative)
Keywords
Bone Healing, Osteotomy, Calcaneus, Bio-integrative, Metallic, Screws
Medical subject headings
Flatfoot, Bone Resorption, Talipes Cavus, Osteolysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Calcaneus Osteotomy (Metallic)Procedure or surgery

    Calcaneus Displacement Osteotomy using two metallic screws

  • Calcaneus Osteotomy (Bio-integrative)Procedure or surgery

    Calcaneus Displacement Osteotomy using two bio-integrative screws

Study groups in NCT05018130
Study groupRoleWhat they receive
Bio-integrativeExperimentalTraditional oblique calcaneus osteotomy through a lateral approach. After a 10mm displacement, the osteotomy will be fixed with two 4.0mm bio-integrative cannulated screws.
Receives: Procedure: Calcaneus Osteotomy (Bio-integrative)
MetallicActive comparatorTraditional oblique calcaneus osteotomy through a lateral approach. After a 10mm displacement, the osteotomy will be fixed with two 4.0mm metallic cannulated screws.
Receives: Procedure: Calcaneus Osteotomy (Metallic)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 weeks

Secondary outcomes (2)

  1. 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.

    Measured: 6 weeks

  2. Implant-related artifact

    • Quantity of Hounsfield units around the implants

    Measured on WBCT acquisitions.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2021
  2. Study start1 Nov 2021
  3. Primary completion30 Jul 2024 (estimated)
  4. Study completion1 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, investigator-blinded, in parallel groups, two-arms, single-center, non-inferiority, clinical trial.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05018130
Sponsor's protocol ID
202106228
Status last verified
Aug 2023
First submitted
10 Aug 2021
Last updated
6 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Nonidentified data will be shared to researchers upon request.

Publications

  • 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.

    PubMed 31375999

  • 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.

    PubMed 35097414

  • 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.

    PubMed 30711319

  • 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.

    PubMed 9116891

  • 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.

    PubMed 23714938

  • 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.

    PubMed 32405207

  • 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.

    PubMed 21345433

  • 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.

    PubMed 29843766

  • 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.

    PubMed 21207026

  • 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.

    PubMed 16624210

Questions about this trial

What is this clinical trial studying?

A study testing Calcaneus Osteotomy (Metallic) and Calcaneus Osteotomy (Bio-integrative) in people with Flatfoot and Bone Resorption, run by University of Iowa at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nacime Salomao Barbachan Mansur, MD, PhD (3194007911, nacime-mansur@iowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bone healing (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05018130, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.

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