InterTAN dual-screw versus single-screw hip nail to improve recovery after unstable intertrochanteric fracture
Official title: Does an Integrated Dual Screw Design Improve Biomechanics and Function Following Fixation of Unstable Intertrochanteric Femur Fractures: A Randomized Pilot Trial (InterTAN)
Run by University of Kentucky · NCT06024304 · Data updated 2026-11-12
This trial will test whether the InterTAN dual-screw hip implant helps people with unstable intertrochanteric hip fractures have less pain and return to walking and normal activity faster than a standard single-screw cephalomedullary nail.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 55 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Status | Recruiting |
| Started | April 18, 2025 |
| Main results expected | January 1, 2027 |
| Study ends | January 1, 2027 |
| Registry record updated | April 7, 2026 |
| Trial ID | NCT06024304 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with non-pathologic unstable intertrochanteric femur fractures (OTA/AO 31A2 or 31A3) who were independently ambulatory without an assistive device before the injury and can consent and complete follow-up assessments.
✕Probably not a fit
Patients with pathological fractures, pre-injury need for ambulatory assistance, chronic pain or active opioid treatment, inability to follow up or consent, or neurological conditions altering gait are unlikely to benefit or be eligible for this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a patient-blinded, randomized pilot trial at the University of Kentucky comparing the InterTAN dual-screw cephalomedullary nail to a single-screw design for unstable intertrochanteric femur fractures. The trial combines biomechanical monitoring (insole load measuring during the inpatient stay and at 2 weeks) with formal gait analysis and functional testing at 6, 12, and 26 weeks and a one-year patient-reported outcome. The primary aims are to determine feasibility of these measurements in the geriatric hip fracture population and to generate longitudinal data on return to symmetric weight bearing, gait mechanics, pain, and function. Results will provide preliminary data to power a larger randomized trial if signals favor the InterTAN device.
Why it matters
Potential benefit: If successful, the InterTAN device could reduce postoperative pain and speed return to symmetric weight-bearing and pre-injury function.
How similar studies have gone: Biomechanical and some clinical studies suggest dual-screw designs like InterTAN improve rotational stability and reduce fixation problems compared to single-screw nails, but randomized clinical evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Non-pathologic fractures * OTA/AO classification 31A2, 31A3 fractures * Ability to participate in 4-MET equivalent activities without ambulatory assistance prior to injury Exclusion Criteria: * Inability to consent * Inability to participate in follow-up activities * History of chronic pain / current opioid treatment * Pre-injury ambulatory status requiring assistance device * Neurological condition altering gait or sensation (e.g. History of stroke with altered gait, peripheral neuropathy).
Where it's running
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University of Kentucky
Lexington, Kentucky, United States Recruiting
Study contacts
- Principal investigator: Paul Matuszewski, MD — University of Kentucky
- Study coordinator: Paul E Matuszewski, MD
- Email: pmatuszewski@uky.edu
- Phone: (859) 323-5533
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.