InterTAN: Integrated Dual Screw Design Improve Biomechanics/Function Following Fixation Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Synthes TFNA, Trigen InterTAN.
- Who it may be relevant to
- Registry conditions: Fracture of Hip. Basic parameters: from 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Does an Integrated Dual Screw Design Improve Biomechanics and Function Following Fixation of Unstable Intertrochanteric Femur Fractures: A Randomized Pilot Trial (InterTAN)
Overview
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.
Interventions
- Device Synthes TFNA
Surgical fixation with single-screw device Synthes TFNA; Pelvic fractures will be repaired utilizing single-screw device Synthes TFNA. - 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.
Primary outcome measures
- 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]
Secondary outcome measures (4)
- Change in Functional Independence Measure [Time frame: 2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months]
- Change in pain assessment [Time frame: 2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months]
- Change in weight bearing [Time frame: 2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months]
- Change in Visual Analog Pain Score [Time frame: 2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Kentucky — Lexington
Identifiers
NCT: NCT06024304 · ORTHO-22-INTERTAN