Arginine and nitric oxide (NO) metabolism during bone healing and non-union development - early prognostic markers

Recruiting

• Conditions: impaired fracture healing; non-union; 10017322

• Registration Number: NL-OMON39646
• Lead Sponsor: Algemene Heelkunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1. Written informed consent
2. Age > 18 years
3. Patient with a fracture of the femur or tibia at the primary surgical procedure and for which a surgical procedure providing bone debris is performed as therapy.

Exclusion Criteria

1. Patients with another bone fracture in their recent medical history (results in
disturbances in the arginine-NO metabolism)
2. Infectious complications, such as infected pseudo-arthrosis (infections causes
decreased argininine production, possibly resulting in impaired fracture healing).
3. Use of chronic corticosteroids (suppresses the immunesystem) or nitrovasodilating
medication (improves the NO metabolism).
4. Patients with severe metabolic disturbances (liver, and renal insufficiency, diabetes).
5. Patients with metastases, haematological malignancies or chemotherapy (results in
disturbances in the arginine-NO metabolism).

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint are the arginine, citrulline, ornithine and Nitric Oxide<br /><br>levels in the plasma during normal and dysfunctional fracture healing the bone<br /><br>in patients with and without non-union</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>none</p><br>