Fracture of HipNCT06024304
InterTAN: Integrated Dual Screw Design Improve Biomechanics/Function Following Fixation Surgery
A study testing Synthes TFNA and Trigen InterTAN in people with Fracture of Hip, run by Paul E. Matuszewski at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Fracture of Hip
- What is being tested?
- Synthes TFNA and Trigen InterTAN
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-pathologic fractures
- OTA/AO classification 31A2, 31A3 fractures
- Ability to participate in 4-MET equivalent activities without ambulatory assistance prior to injury
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40506
Matthew Eubank, (859) 323-5533, mseuba01@uky.edu
About this study
Official title: Does an Integrated Dual Screw Design Improve Biomechanics and Function Following Fixation of Unstable Intertrochanteric Femur Fractures: A Randomized Pilot Trial (InterTAN)
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.
Read the 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
- Being tested
- Synthes TFNA, Trigen InterTAN
- Keywords
- Surgical Fixation, Cephalomedullary nail
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synthes TFNADevice
Surgical fixation with single-screw device Synthes TFNA; Pelvic fractures will be repaired utilizing single-screw device Synthes TFNA.
Trigen InterTANDevice
Surgical fixation with Smith and Nephew Trigen InterTAN cephalomedullary long nail; Pelvic fractures will be repaired utilizing Smith and Nephew Trigen InterTAN.
| Study group | Role | What they receive |
|---|---|---|
| Trigen InterTan | Active comparator | Patients in this arm will be implanted with the cephalomedullary nail Trigen InterTan manufactured by Smith \& Nephew. Receives: Device: Trigen InterTAN |
| Synthes TFNA | Active comparator | Patients in this arm will be implanted with the single-screw device TFNA manufactured by DePuy Synthes. Receives: Device: Synthes TFNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months
Secondary outcomes (4)
Change in Functional Independence Measure
The Functional Independence Measure (FIM) is a tool used to measure the level of disability as well as the change in patient status. FI is comprised of 18 items, grouped into 2 subscales - motor and cognition. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item.
Measured: 2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months
Change in pain assessment
Brief Pain Inventory (BPI) will be used to measure pain intensity. This is a four-item scale that measures current, worst, least, and average pain. Each of these four items are measured on a numeric scale from 0 to 10 with 0 being ''no pain'' and 10 being ''severe pain.''
Measured: 2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months
Change in weight bearing
The ground reaction forces of the injured and non injured limb will be evaluated over the course of recovery to assess when loading between limbs becomes symmetric during their physical therapy.
Measured: 2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months
Change in Visual Analog Pain Score
The visual analog pain score is a horizontal line with a scale ranging from 0 to 10 where a higher number indicates more pain.
Measured: 2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start18 Apr 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot, patient blinded randomized trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paul E. Matuszewski
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paul E. Matuszewski, University of Kentucky
- Investigators
- Paul Matuszewski, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024304
- Sponsor's protocol ID
- ORTHO-22-INTERTAN
- Status last verified
- Mar 2026
- First submitted
- 13 Apr 2022
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does an Integrated Dual Screw Design Improve Biomechanics and Function Following Fixation of Unstable Intertrochanteric Femur Fractures: A Randomized Pilot Trial (InterTAN)
- ClinicalTrials.gov ID
- NCT06024304
- Acronym / sponsor ID
- ORTHO-22-INTERTAN
- Conditions
- Fracture of Hip
- Keywords
- Surgical Fixation, Cephalomedullary nail
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Paul E. MatuszewskiUniversity, hospital or other
- Study start
- 18 Apr 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Pilot, patient blinded randomized trial
| Arm | Type | Receives |
|---|---|---|
| Trigen InterTan | Active comparator | Device: Trigen InterTANPatients in this arm will be implanted with the cephalomedullary nail Trigen InterTan manufactured by Smith \& Nephew. |
| Synthes TFNA | Active comparator | Device: Synthes TFNAPatients in this arm will be implanted with the single-screw device TFNA manufactured by DePuy Synthes. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non-pathologic fractures
- OTA/AO classification 31A2, 31A3 fractures
- Ability to participate in 4-MET equivalent activities without ambulatory assistance prior to injury
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synthes TFNASurgical fixation with single-screw device Synthes TFNA; Pelvic fractures will be repaired utilizing single-screw device Synthes TFNA. | Device | Synthes TFNA |
| Trigen InterTANSurgical fixation with Smith and Nephew Trigen InterTAN cephalomedullary long nail; Pelvic fractures will be repaired utilizing Smith and Nephew Trigen InterTAN. | Device | Trigen InterTan |
Primary outcome
Change in self-reported physical function
Time frame: 2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months
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.
Change in self-reported pain
Time frame: 2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Matuszewski, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synthes TFNA and Trigen InterTAN in people with Fracture of Hip, run by Paul E. Matuszewski at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul E Matuszewski, MD ((859) 323-5533, pmatuszewski@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported physical function (time frame: 2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.