Status:
RECRUITING
Osteogenon in Orthopedics and Traumatology
Lead Sponsor:
University of Opole
Conditions:
Patients With Fractures
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief 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 positi...
Detailed Description
The role of ossein-hydroxyapatite complex in fracture healing requires further research. The aim of the study was to evaluate the effect of ossein-hydroxyapatite complex (Osteogenon) as an adjunctive...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07210281
Start Date
November 1 2024
End Date
December 30 2027
Last Update
November 28 2025
Active Locations (1)
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1
University Clinical Hospital in Opole
Opole, Opole Voivodeship, Poland, 46-020