Recruiting

InterTAN vs. Lag-Screw

Sponsor:

Paul E. Matuszewski

Code:

NCT06024304

Conditions

Fracture of Hip

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Synthes TFNA

Trigen InterTAN

Study Details

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.

Conditions

Fracture of Hip

Study ID

NCT06024304

Start date

Apr 18, 2025

Status verified date

Mar, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Synthes TFNA

Surgical fixation with single-screw device Synthes TFNA; Pelvic fractures will be repaired utilizing single-screw device Synthes TFNA.

Trigen InterTAN

Surgical fixation with Smith and Nephew Trigen InterTAN cephalomedullary long nail; Pelvic fractures will be repaired utilizing Smith and Nephew Trigen InterTAN.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Paul E Matuszewski, MD

(859) 323-5533pmatuszewski@uky.edu

Matthew Eubank

(859) 323-5533mseuba01@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40506

Contacts

Matthew Eubank

(859) 323-5533mseuba01@uky.edu

More Information

Sponsor

Paul E. Matuszewski

Last update posted

Apr 7, 2026

Last verified

Mar, 2026

Keywords

  • Surgical Fixation
  • Cephalomedullary nail

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Paul E. Matuszewski on 2026-04-07.