Comparison of Healing Measures Tibial Fractures Following Standard Intramedullary Nailing or Micromotion Tibial Intramedullary Nailing
Not Applicable
Recruiting
- Conditions
- Tibial Fractures
- Registration Number
- NCT06679049
- Lead Sponsor
- University of Alabama at Birmingham
- Brief Summary
The primary purpose of this study is to perform a high-quality randomized control trial comparing intramedullary tibial nail fixation with standard design nails to a micromotion tibial nail device, to evaluate the rates of union and post-operative outcomes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Age 18 - 85 years
- Stable Tibial fracture recommended for surgical intervention
Exclusion Criteria
- Patients not meeting inclusion criteria
- Unstable fracture patterns e.g. those needing a secondary intervention - masquelet/cement spacer)
- Previously non-ambulatory patients
- Delayed presentation of fracture (>4 weeks)
- Fractures that the treating surgeon indicates requires additional fixation strategies to achieve stability
- Patients with an achieve infection or wound at the surgical site
- Any previous ligament or fracture surgery on the index site
- Inflammatory rheumatic disease or other rheumatic disease-
- Immune compromised patients (hepatitis, HIV, etc.)
- Unwilling or unable to participate or follow study protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The difference in radiographic union 12,18 and 24 weeks between micromotion intramedullary fixation and standard IMN post operatively bridging callus, minimum three cortices bridged
- Secondary Outcome Measures
Name Time Method difference in complication rates 1 year post-operatively Patient reported outcomes scores
Trial Locations
- Locations (1)
University of Alabama at Birmingham Main Hospital
🇺🇸Birmingham, Alabama, United States