NCT06024304 InterTAN: Integrated Dual Screw Design Improve Biomechanics/Function Following Fixation Surgery
| NCT ID | NCT06024304 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Paul E. Matuszewski |
| Condition | Fracture of Hip |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-04-18 |
| Primary Completion | 2027-01-01 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 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).