Comparing two types of intramedullary nails for healing tibial fractures
Comparison of Healing Measures in Diaphyseal Tibial Fractures Following Standard Intramedullary Nailing or Micromotion Tibial Intramedullary Nailing
This study is testing whether a new type of tibial nail helps people with stable tibial fractures heal better and recover faster than the standard nail.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT06679049 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of standard intramedullary nails versus a micromotion tibial nail device in treating stable tibial fractures. It is a randomized control trial that will evaluate the rates of bone union and post-operative outcomes in patients undergoing surgical intervention. Participants will be monitored for their recovery and healing progress following the different fixation methods. The goal is to determine which method provides better results in terms of healing and recovery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with stable tibial fractures that require surgical intervention.
Not a fit: Patients with unstable fracture patterns or those requiring additional fixation strategies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved healing outcomes for patients with tibial fractures.
How similar studies have performed: Other studies have shown varying success with different intramedullary nail designs, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham Main Hospital — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Joseph Johnson, MD — University of Alabama at Birmingham
- Study coordinator: Joseph Johnson, MD
- Email: jpjohnso@uab.edu
- Phone: 205-934-1041
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.