RecruitingPhase 4NCT07210281

Osteogenon in Orthopedics and Traumatology

The Use of Ossein-hydroxyapatite Complex as an Adjunctive Treatment in Orthopedics and Traumatology

Sponsor

University of Opole

Enrollment

150 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

Patients With Fractures

Summary

The aim of this study was to evaluate the supportive effect of the ossein-hydroxyapatite complex in fracture healing. The investigators hypothesized that the ossein-hydroxyapatite complex would positively impact fracture healing outcomes.The assessment covers clinical, radiological and biomechanical parameters.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria8

no contraindications to taking Osteogenon
a follow-up period of more than 3 months after treatment completion
complete medical and radiological records
a written informed consent
not taking any other medications that could affect bone tissue remodeling
not taking other medications that interact with Osteogenon
no other limb pathologies (inflammatory or neurogenic)
absence of comorbidities that could affect bone union

Exclusion Criteria16

age under 18 years or over 85 years
hypersensitivity to the active ingredient or to any of the excipients
severe renal failure and dialysis therapy
hypercalcemia
hypercalciuria
calcium-based kidney stones or tissue calcifications
a follow-up period shorter than 3 months after treatment completion
a lack of informed consent
a lack of cooperation with the patient
absent or incomplete medical and radiological records
taking medications that could affect bone tissue remodeling
taking medications that may interact with Osteogenon (e.g. thiazide diuretics)
metabolic disorders
post-traumatic skeletal deformities
neuromuscular disorders
post-inflammatory deformities

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Interventions

DRUGreceived an ossein-hydroxyapatite complex

Patients in the study group with fractures received an ossein-hydroxyapatite complex (830 mg of ossein-and-hydroxyapatite complex, with 444 mg of hydroxyapatite, equivalent to 178 mg of calcium and 82 mg of phosphorus) throughout the entire period following fracture healing. The tablets were taken orally, one tablet twice daily.

Locations(1)

University Clinical Hospital in Opole

Opole, Opole Voivodeship, Poland

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NCT07210281