InterTAN: Integrated Dual Screw Design Improve Biomechanics/Function Following Fixation Surgery
NCT06024304 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-04-07
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.
Conditions
- Fracture of Hip
Interventions
- DEVICE
-
Synthes TFNA
Surgical fixation with single-screw device Synthes TFNA; Pelvic fractures will be repaired utilizing single-screw device Synthes TFNA.
- DEVICE
-
Trigen InterTAN
Surgical fixation with Smith and Nephew Trigen InterTAN cephalomedullary long nail; Pelvic fractures will be repaired utilizing Smith and Nephew Trigen InterTAN.
Sponsors & Collaborators
-
Paul E. Matuszewski
lead OTHER
Principal Investigators
-
Paul Matuszewski, MD · University of Kentucky
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-18
- Primary Completion
- 2027-01-01
- Completion
- 2027-01-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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