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

NCT06024304 | Not Yet Recruiting

• 1 other identifier: ORTHO-22-INTERTAN
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Keywords

Surgical Fixation; Cephalomedullary nail

Outcome Measures

Primary Outcomes (2)

• Change in self-reported physical function

  Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Questionnaire is a 53 question survey with a five point Likert scale ranging from 1 to 5 where a higher number indicates less physical function.

  2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months

• Change in self-reported pain

  Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Questionnaire is a 56 question survey with a five point Likert scale ranging from 1 to 5 where a higher number indicates increased interference due to pain.

  2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months

Secondary Outcomes (4)

• Change in Functional Independence Measure

  2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months

• Change in pain assessment

  2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months

• Change in weight bearing

  2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months

• Change in Visual Analog Pain Score

  2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months

Study Arms (2)

Trigen InterTan

ACTIVE COMPARATOR

Patients in this arm will be implanted with the cephalomedullary nail Trigen InterTan manufactured by Smith \& Nephew.

Device: Trigen InterTAN

Synthes TFNA

ACTIVE COMPARATOR

Patients in this arm will be implanted with the single-screw device TFNA manufactured by DePuy Synthes.

Device: Synthes TFNA

Interventions

Synthes TFNA DEVICE

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

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.

Trigen InterTan

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-pathologic fractures
• OTA/AO classification 31A2, 31A3 fractures
• Ability to participate in 4-MET equivalent activities without ambulatory assistance prior to injury

You may not qualify if:

• 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).

Sponsors & Collaborators

• Paul E. Matuszewski: lead

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Paul Matuszewski, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul E Matuszewski, MD

CONTACT

(859) 323-5533; pmatuszewski@uky.edu

Matthew Eubank

CONTACT

(859) 323-5533; mseuba01@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Pilot, patient blinded randomized trial

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: September 6, 2023
• Study Start: August 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share