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

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Paul E. Matuszewski
Study ID
NCT06024304
Status
Recruiting
Apply to this trial

Conditions

  • Fracture of Hip

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Synthes TFNA — DEVICE
    Surgical fixation with single-screw device Synthes TFNA; Pelvic fractures will be repaired utilizing single-screw device Synthes TFNA.
  • Trigen InterTAN — DEVICE
    Surgical fixation with Smith and Nephew Trigen InterTAN cephalomedullary long nail; Pelvic fractures will be repaired utilizing Smith and Nephew Trigen InterTAN.

Study Details

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.

Key Dates

Start date
Apr 18, 2025
Status verified
Mar 2026
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Trigen InterTan
    Patients in this arm will be implanted with the cephalomedullary nail Trigen InterTan manufactured by Smith \& Nephew.
  • Active Comparator: Synthes TFNA
    Patients in this arm will be implanted with the single-screw device TFNA manufactured by DePuy Synthes.

Primary Outcome Measure

Change in self-reported physical function [ Time Frame: 2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40506
Matthew Eubank
[email protected]
(859) 323-5533

Find similar trials in Lexington, KY

By research site
University of Kentucky· Lexington, KY

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