Trigen InterTAN for Hip Fracture
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how a new hip implant, the InterTAN, can improve recovery after a specific type of hip fracture. Researchers aim to determine if this implant reduces post-surgery pain and enables quicker return to walking and daily activities compared to a standard implant. Participants must have experienced a hip fracture and been able to walk unaided before the injury. As an unphased trial, this study allows patients to contribute to innovative research that could enhance recovery outcomes for future hip fracture patients.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on opioid treatment for chronic pain, you would not be eligible to participate.
What prior data suggests that the InterTAN device is safe for hip fracture treatment?
Research has shown that the InterTAN device is generally well-tolerated for treating hip fractures. One study found that 95.5% of patients did not need additional surgery within 2.5 years, indicating the device's reliability and low complication rate. Patients using InterTAN have reported less pain, which may aid in walking and moving more easily after surgery. Another study found that InterTAN has a lower risk of failure compared to other devices, enhancing its safety profile. Regarding side effects, studies have not identified any major safety concerns specific to InterTAN, suggesting it is a safe option for treating hip fractures.12345
Why are researchers excited about this trial?
Unlike the standard of care for hip fractures, which often involves traditional fixation devices, the Trigen InterTAN uses a cephalomedullary nail design. This design is unique because it combines both a compression hip screw and an intramedullary nail in one device, aiming to provide better stability and faster healing. Researchers are excited about this treatment because it has the potential to reduce complications and improve recovery times compared to conventional methods. In contrast, the Synthes TFNA employs a single-screw mechanism, offering a different approach that might also lead to enhanced outcomes for patients. These innovations could revolutionize the way hip fractures are treated, offering patients quicker and more reliable recoveries.
What evidence suggests that the InterTAN is effective for hip fracture treatment?
Research shows that the Trigen InterTAN nail effectively fixes certain types of hip fractures. Studies find that about 97% of patients heal properly with this device. It also boasts a high success rate, with about 95.5% of patients not needing another surgery after 2.5 years. Patients often experience less pain soon after surgery and improved hip movement. In this trial, some participants will receive the Trigen InterTAN nail, while others will be treated with the Synthes TFNA device. The Trigen InterTAN treatment also presents a lower risk of implant-related problems compared to some other devices.45678
Who Is on the Research Team?
Paul Matuszewski, MD
Principal Investigator
University of Kentucky
Are You a Good Fit for This Trial?
This trial is for people with specific types of hip fractures (OTA/AO 31A2 or 31A3) who could walk and do moderate activities without help before their injury. It excludes those with bone disease-related (pathologic) fractures.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo surgical fixation of unstable intertrochanteric femur fractures using either the InterTAN or SSCMN device
Post-operative Monitoring
Pain and weight bearing are assessed during hospital stay and at follow-up visits
Follow-up
Participants are monitored for function, pain, and weight bearing at multiple intervals post-surgery
What Are the Treatments Tested in This Trial?
Interventions
- InterTAN
Trial Overview
The study compares two surgical devices—InterTAN and Synthes TFNA—for fixing unstable hip fractures. Patients are randomly assigned to one device, and the trial looks at pain, walking ability, and recovery after surgery.
How Is the Trial Designed?
2
Treatment groups
Active Control
Patients in this arm will be implanted with the cephalomedullary nail Trigen InterTan manufactured by Smith \& Nephew.
Patients in this arm will be implanted with the single-screw device TFNA manufactured by DePuy Synthes.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Paul E. Matuszewski
Lead Sponsor
Citations
Learning Curve and Clinical Outcomes of Performing Surgery ...
This study demonstrated that the learning curve of performing surgery with the InterTan intramedullary nail is acceptable and 90% of the expert's proficiency ...
Mechanical outcomes of the TFNA, InterTAN and IMHS ...
The cumulative survival rates without revision for the. TFNA, InterTAN, IMHS groups were 97.8 %, 95.5 % and 87.9 % respectively at 2.5 years.
Mechanical outcomes of the TFNA, InterTAN and IMHS ...
The cumulative survival rates without revision for the TFNA, InterTAN, IMHS groups were 97.8 %, 95.5 % and 87.9 % respectively at 2.5 years. Discussion. The ...
4.
smith-nephew-delivery.stylelabs.cloud
smith-nephew-delivery.stylelabs.cloud/api/public/content/ec197ad6a8a34f969a83c382772cddf0?v=050d337a&download=trueTRIGEN◊ INTERTAN◊ Intertrochanteric Antegrade Nail
TRIGEN INTERTAN demonstrated reductions in the risk of revision/reoperation, implant-related failure, and hip and thigh pain when compared with other IM nails ( ...
5.
orthopedicreviews.openmedicalpublishing.org
orthopedicreviews.openmedicalpublishing.org/article/94277-the-retrospective-analysis-of-trigen-intertan-nail-in-the-treatment-of-unstable-intertrochanteric-femoral-fractures-at-hospital-for-traumatology-and-oTHE RETROSPECTIVE ANALYSIS OF TRIGEN INTERTAN ...
Surgical Outcomes. At the final assessment, 97.14% of cases achieved bone union, with only 1 case (2.86%) showing non-union. Six months ...
Comparison of clinical outcomes with proximal femoral nail ...
InterTAN nail has better clinical manifestation than PFNA in treating unstable femoral intertrochanteric fractures.
Mechanical outcomes of the TFNA, InterTAN and IMHS ...
The cumulative survival rates without revision for the TFNA, InterTAN, IMHS groups were 97.8 %, 95.5 % and 87.9 % respectively at 2.5 years. Discussion: The ...
8.
ctv.veeva.com
ctv.veeva.com/study/a-study-to-evaluate-the-safety-and-effectiveness-of-trigen-intertan-10s-modelsA Study to Evaluate the Safety and Effectiveness of TRIGEN ...
This is a post-market study to evaluate the revision rate of femoral fractures, treated with INTERTAN 10S Nails at one-year post-operation.
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