InterTAN: Integrated Dual Screw Design Improve Biomechanics/Function Following Fixation Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorPaul E. Matuszewski

About this trial

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

Qualifiers

Non-pathologic fractures

OTA/AO classification 31A2, 31A3 fractures

Ability to participate in 4-MET equivalent activities without ambulatory assistance prior to injury

Disqualifiers

Inability to consent

Inability to participate in follow-up activities

History of chronic pain / current opioid treatment

Pre-injury ambulatory status requiring assistance device

Trial design

Treatments tested in this trial

  • Synthes TFNA
  • Trigen InterTAN

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Paul E. Matuszewski

Lead sponsor

University of Kentucky

Sponsor institution