Implant Fixation for Broken Bones
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines two methods for repairing broken bones in the distal femur, the lower part of the thigh. The goal is to determine which surgical technique enables quicker return to work and daily activities. Single Implant Fixation uses one implant, while Dual Implant Fixation employs two implants for additional support. Suitable participants are those aged 55 or older who have undergone surgery for distal femur fractures. As an unphased trial, it provides participants the chance to contribute to valuable research that could enhance recovery methods for future patients.
What prior data suggests that these surgical fixation methods are safe for treating distal femur fractures?
Previous studies have shown good results using two implants to fix broken thigh bones. Research indicates that most patients heal successfully with stable support. However, infection rates vary from none to about 16.7%, meaning some patients may face risks, but many do not. Additionally, this treatment improves recovery with a low chance of problems like hip dislocation.
Overall, using two implants appears well-tolerated by most patients, leading to positive recovery outcomes. However, it is important to consider possible risks, such as infections, when evaluating this option.12345Why are researchers excited about this trial?
Researchers are excited about dual implant fixation for broken bones because it combines two implants, potentially offering enhanced stability and support compared to the single implant approach. The dual implant method uses a lateral locking plate in conjunction with either an intramedullary nail or an additional medial plate, aiming to improve bone healing and reduce recovery time. This contrasts with the standard single implant fixation, which involves either a lateral locking plate or an intramedullary nail alone. By utilizing two implants, the dual approach may provide a more robust solution for complex fractures, leading to better outcomes for patients.
What evidence suggests that this trial's treatments could be effective for distal femur fractures?
This trial will compare Dual Implant Fixation with Single Implant Fixation for distal femur fractures. Studies have shown that using two implants, as in the Dual Implant Fixation arm of this trial, can lead to good results. Research indicates that all patients treated with two implants experienced successful bone healing, without major issues like infections or improper healing. In another study, patients demonstrated good movement and health outcomes when two implants targeted different parts of the fracture. These findings suggest that using two implants can effectively aid bone healing and improve recovery for patients with these types of fractures.13567
Who Is on the Research Team?
Laurence Kempton, M.D.
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
This trial is for people aged 55 or older who have a broken bone near the end of their thigh bone (distal femur) that needs surgery. Only those with certain types of fractures are included.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo surgical fixation of distal femur fractures using either single or dual implant fixation
Follow-up
Participants are monitored for surgical outcomes, reoperations, and recovery progress
Long-term Follow-up
Participants are assessed for long-term outcomes such as post-traumatic arthritis and quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Dual Implant Fixation
- Single Implant Fixation
Trial Overview
The study compares two surgical methods to fix these fractures: using one implant versus using two implants. Patients are randomly assigned to either group to see which helps them recover daily function better.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Single implant fixation with either a precontoured lateral locking plate or an intramedullary nail which is the current standard of care.
Dual implant fixation with either a lateral locking plate plus an intramedullary nail or a lateral locking plate plus a supplemental medial plate which is the current standard of care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
Citations
1.
researchgate.net
researchgate.net/publication/414659193_Clinical_and_radiological_outcomes_of_double_plating_in_periprosthetic_distal_femur_fractures_after_total_knee_arthroplastyClinical and radiological outcomes of double plating in ...
Overall, fracture healing was achieved in all patients. One patient required outpatient debridement and oral antibiotics for wound complications ...
2.
healthcare_technology.cureus.com
healthcare_technology.cureus.com/articles/63601-outcome-analysis-of-dual-implant-osteosynthesis-for-ipsilateral-proximal-and-shaft-femur-fractures-do-we-need-cephalomedullary-nails.pdf?email=Do We Need Cephalomedullary
We had a satisfactory functional and clinical outcome of managing these fractures with two implants, one focusing biomechanically on each ...
3.
profiles.wustl.edu
profiles.wustl.edu/en/publications/integrated-dual-lag-screws-have-higher-reoperation-rates-for-fixa/Integrated Dual Lag Screws Have Higher Reoperation ...
Conclusions:Intertrochanteric femoral fractures treated with an IDL CMN were associated with low but significantly higher rates and ...
4.
epocrates.com
epocrates.com/online/article/dual-mobility-hip-implant-cuts-dislocation-risk-after-fractureDual mobility hip implant cuts dislocation risk after fracture
Hip dislocation occurred in 1.3% of patients who received a dual mobility implant compared with 4.2% of those who received a standard cup—a ...
A Prospective Study on Functional Outcome of Double Plating ...
In our study, 30 patients were treated with dual plating of the distal femur through modified anterior approach (Swashbuckler). The approach provides adequate ...
Single Versus Dual Implant Fixation of Distal Femur Fractures
The goal of this clinical trial is to compare two types of surgical fixation in patients with specific kinds of distal femur fractures.
Biomechanical Evaluation of Dual Plate Configurations for ...
Dual plating fixation achieved an adequate quality of supracondylar femoral fracture reduction with no implant loosening during follow-up [37].
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