InterTAN: Integrated Dual Screw Design Improve Biomechanics/Function Following Fixation Surgery
Does an Integrated Dual Screw Design Improve Biomechanics and Function Following Fixation of Unstable Intertrochanteric Femur Fractures: A Randomized Pilot Trial (InterTAN)
Paul E. Matuszewski
30 participants
Apr 18, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this pilot, patient blinded randomized trial is to develop a mechanistic understanding of gait following fixation of unstable intertrochanteric hip fractures and return to function and pain control. The guiding hypothesis that will be tested in a subsequent clinical trial is that the InterTAN when compared to standard lag-screw cephalomedullary nails will have decreased post operative pain, earlier return to symmetric weight bearing, and quicker return to pre-injury functioning levels.
Eligibility
Inclusion Criteria3
- Non-pathologic fractures
- OTA/AO classification 31A2, 31A3 fractures
- Ability to participate in 4-MET equivalent activities without ambulatory assistance prior to injury
Exclusion Criteria5
- 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).
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Interventions
Surgical fixation with single-screw device Synthes TFNA; Pelvic fractures will be repaired utilizing single-screw device Synthes TFNA.
Surgical fixation with Smith and Nephew Trigen InterTAN cephalomedullary long nail; Pelvic fractures will be repaired utilizing Smith and Nephew Trigen InterTAN.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06024304