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

NCT ID: NCT06024304

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2027-01-01

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.

Detailed Description

Aim 1: Determine the feasibility of conducting a randomized trial assessing gait mechanics as well as outcomes following unstable intertrochanteric femur fractures treated with cephalomedullary nails. This will be achieved by performing a pilot randomized trial comparing the InterTAN versus a single-screw design cephalomedullary nail (SSCMN). Deliverable: Preliminary data to support a larger randomized trial powered on either mechanical assessments or patient reported outcomes. Feasibility of conducting comprehensive biomechanical and patient related outcome measurements in the geriatric hip fracture population.

Aim 2: Determine the pathway to return to function and symmetric weight bearing. Load bearing will be assessed through insole monitoring during their inpatient stay and 2-weeks post-op. Additionally, analysis will be performed to measure gait for hip motion, loading, strength and functional assessments at 6,12, and 26 weeks post-op. Patients will also be assessed at 1-year for reported function as well. Hypothesis: Patients in the InterTAN group will have faster return to symmetrical weight bearing/motion and earlier return to function. Deliverable: Longitudinal data assessing return to function and weight bearing in intertrochanteric femur fractures.

Aim 3: Determine if use of the InterTAN device when compared to SSCMN results in decreased pain following unstable intertrochanteric femur fractures. Patients will be enrolled in a prospective trial with standardized pain control regimen, assessing patients for pain during their hospital stay using Area Under the Curve Analysis of Visual Analogue Pain Scores at 24, 48 and 72 hours. Similarly, opioid usage in morphine milligram equivalents will be assessed. Pain will be assessed at follow-up visits 6, 12, 26, 52 weeks. Hypothesis: The InterTAN will result in decreased pain in the immediate post-operative period and in sub-acute post-operative period.

Aim 4: Determine if the use of the InterTAN device when compared to SSCMN results in decreased healthcare utilization. Participation with therapy, hospital length of stay, discharge disposition, and time-spent in rehabilitation facility will be assessed. Hypothesis: Patients in the InterTAN group will be more likely to be discharged home, participate with therapy more, have decreased length of stay in both inpatient and outpatient units. Deliverable: Data to inform the power analysis for a larger prospective clinical trial.

Conditions

Fracture of Hip

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Trigen InterTan

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

Group Type: ACTIVE_COMPARATOR

Trigen InterTAN

Intervention Type: DEVICE

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

Synthes TFNA

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

Group Type: ACTIVE_COMPARATOR

Synthes TFNA

Intervention Type: DEVICE

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

Interventions

Synthes TFNA

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

Intervention Type: 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.

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Paul E. Matuszewski

OTHER

Sponsor Role: lead

Responsible Party

Paul E. Matuszewski

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Paul Matuszewski, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Central Contacts

Paul E Matuszewski, MD

Role: CONTACT

pmatuszewski@uky.edu

(859) 323-5533

Matthew Eubank

Role: CONTACT

mseuba01@uky.edu

(859) 323-5533

Other Identifiers

ORTHO-22-INTERTAN

Identifier Type: -

Identifier Source: org_study_id