Impact of NSAIDs on delayed fracture healing

Phase 2

• Conditions: Tibial shaft fracture; Femoral shaft fracture; Injuries and Accidents - Fractures

• Registration Number: ACTRN12619001376134
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-09
• Last Update Posted: 14 October 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Participants will be eligible if they meet the following inclusion criteria:
- at least one tibial or femoral shaft fracture managed with either intramedullary nailing or plating
- an acute hospital length of stay>24 hours at The Alfred Hospital
- aged 18-65 years.

Exclusion Criteria

Participants will be excluded if they present with:
- a pathological fracture related to metastatic disease, severe traumatic brain injury and/or spinal cord injury (recovery trajectory varies significantly from the majority of participants)
- less than conversational-level English (inability to engage in interviewing)
- multiple major fractures (bilateral tibia and/or femur; unilateral tibia and femur)
- a Glomerular Filtration Rate (GFR) below 60 mL/ min/1.73m2 or any contraindications to NSAID use (for example: known hypersensitivity including asthma/urticarial/allergic type reactions, allergy to sulphonamides, unstable ischaemic heart disease or thrombus or myocardial infarction or stroke within 3 months, active peptic ulceration or gastrointestinal bleeding, congestive heart failure NYHA II-IV, severe hepatic impairment – (Child-Pugh score greater or equal to 10).
- opioid and benzodiazepine addiction or opioid tolerance, and other regular illicit drug use or problematic alcohol use

Study & Design

• Study Type: Interventional
• Study Design: Not specified