InterTAN: Integrated Dual Screw Design Improve Biomechanics/Function Following Fixation Surgery
ConditionFracture of Hip
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorPaul E. Matuszewski
About this trial
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
This trial does not accept healthy volunteersQualifiers
Non-pathologic fractures
OTA/AO classification 31A2, 31A3 fractures
Ability to participate in 4-MET equivalent activities without ambulatory assistance prior to injury
Disqualifiers
Inability to consent
Inability to participate in follow-up activities
History of chronic pain / current opioid treatment
Pre-injury ambulatory status requiring assistance device
Trial design
Design model
Parallel
Treatments tested in this trial
Synthes TFNA
DeviceSurgical fixation with single-screw device Synthes TFNA; Pelvic fractures will be repaired utilizing single-screw device Synthes TFNA.
Trigen InterTAN
DeviceSurgical fixation with Smith and Nephew Trigen InterTAN cephalomedullary long nail; Pelvic fractures will be repaired utilizing Smith and Nephew Trigen InterTAN.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Trigen InterTanActive comparator 1 intervention
Group B: Synthes TFNAActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months2
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.
Time frame
2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 monthsSecondary outcomes
1
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.
Time frame
2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months2
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.''
Time frame
2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months3
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.
Time frame
2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 months4
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.
Time frame
2 weeks, 6 weeks, 12 weeks, 26 weeks, 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Paul E. Matuszewski
Lead sponsor
University of Kentucky
Sponsor institution
Source ClinicalTrials.gov