InterTAN dual-screw versus single-screw hip nail to improve recovery after unstable intertrochanteric fracture
Does an Integrated Dual Screw Design Improve Biomechanics and Function Following Fixation of Unstable Intertrochanteric Femur Fractures: A Randomized Pilot Trial (InterTAN)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT06024304 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Lexington, Kentucky
- 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
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.