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Study aim:
To investigate the bone regeneration efficacy of NMImETIC peptide nanofibers
To assess callus formation before and after the application of NMImETIC peptide nanofibers
Design:
This study is a prospective Phase 1 clinical trial. The study population will include patients presenting with impaired bone healing at the fracture site. Based on the study conducted at the Royan Institute (NCT Identifier: NCT01210950), a sample size of 6 patients was determined, with outcomes compared between pre- and post-intervention assessments. This is a non-randomized, open-label study, meaning neither patients nor surgeons are blinded to the treatment
Settings and conduct:
Patients presenting with impaired bone healing will receive an injection of NMImETIC peptide nanofibers at the defect site at Omid Hospital or Dr. Mottalebizadeh’s clinic.
1. Infection and pain intensity at 2 weeks
4 months follow-up:
2. Callus formation: AP and lateral radiographic projections
3. Quantitative evaluation: RUST Score
4. Delayed and Nonunion
Participants/Inclusion and exclusion criteria:
Inclusion
1. Age: 18 to 70 years.
2. Gender: Both males and females.
3. Clinical history: Patients who underwent MTN surgery and exhibited 4. suboptimal bone healing at the 4-month post-operative follow-up.
Compliance: Willingness to participate in and adhere to all phases of the study protocol.
Exclusion
Alcohol consumption.
Pregnancy or lactation.
Uncontrolled diabetes mellitus.
Autoimmune or immunodeficiency disorders.
Medical conditions that could interfere with study outcomes
A history of intravenous bisphosphonate therapy.
Malignancy (cancer) or current chemotherapy treatment.
Conditions related to calcium malabsorption.
Tobacco use
Intervention groups:
In this study, NMImETIC Peptide Nanofibers will be used in individuals with leg length discrepancy who have not responded to bone repair.
Main outcome variables:
Bone Regeneration