OsteogenonOssein-Hydroxyapatite Complex for Fracture Healing in Orthopedics
received an ossein-hydroxyapatite complex
Wrist Fractures+2
+ Arm Injuries
+ Wounds and Injuries
Treatment Study
Summary
Study start date: November 1, 2024
Actual date on which the first participant was enrolled.This clinical trial investigates the use of a special compound called ossein-hydroxyapatite complex, also known as Osteogenon, to help in the healing of bone fractures. The study focuses on patients who have experienced bone fractures and aims to see if taking this compound, along with standard fracture treatments, can improve recovery outcomes. Researchers hope to demonstrate that Osteogenon can effectively support bone healing, which would be a significant advancement in fracture treatment and potentially lead to its broader use in trauma centers worldwide. Participants in this study consist of two groups: one receiving Osteogenon and a control group not receiving it. Those in the Osteogenon group take one tablet orally, twice a day, throughout their recovery. Both groups follow the same rehabilitation protocols and undergo similar assessments for bone healing, pain levels, and recovery times. The study measures various factors such as the time required for bone healing, the amount of pain relief, and the speed at which patients can return to normal activities. By comparing these results, the study aims to determine the effectiveness of Osteogenon in enhancing fracture healing and reducing complications.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.150 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 85 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * 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 Criteria: * 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University Clinical Hospital in Opole
Opole, PolandOpen University Clinical Hospital in Opole in Google Maps