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Recruiting NCT06024304

NCT06024304 InterTAN: Integrated Dual Screw Design Improve Biomechanics/Function Following Fixation Surgery

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Clinical Trial Summary
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

Eligibility & Interventions

Sex All sexes
Min Age 55 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Synthes TFNATrigen InterTAN

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 30 participants in total. It began in 2025-04-18 with a primary completion date of 2027-01-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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).

Contact & Investigator

Central Contact

Paul E Matuszewski, MD

✉ pmatuszewski@uky.edu

📞 (859) 323-5533

Principal Investigator

Paul Matuszewski, MD

PRINCIPAL INVESTIGATOR

University of Kentucky

Frequently Asked Questions

Who can join the NCT06024304 clinical trial?

This trial is open to participants of all sexes, aged 55 Years or older, studying Fracture of Hip. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06024304 currently recruiting?

Yes, NCT06024304 is actively recruiting participants. Contact the research team at pmatuszewski@uky.edu for enrollment information.

Where is the NCT06024304 trial being conducted?

This trial is being conducted at Lexington, United States.

Who is sponsoring the NCT06024304 clinical trial?

NCT06024304 is sponsored by Paul E. Matuszewski. The principal investigator is Paul Matuszewski, MD at University of Kentucky. The trial plans to enroll 30 participants.

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