University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267, United States
Location status: Recruiting
NCT Number: NCT06409559
The hypothesis of this study is that the Rim Plate method utilizing interfragmentary screws placed through the plate will result in superior fixation, a lower rate of loss of reduction of the fracture fragment, better anatomic healing of the articular (joint) surface, a decreased rate of early post-traumatic arthritic changes of the joint (cartilage) surface, and improved functional outcomes.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Cincinnati, Ohio, 45267, United States
Location status: Recruiting
Study type: Interventional Estimated enrollment: 60 Allocation: block randomization. The block randomization method is designed to randomize subjects into groups that result in equal sample sizes. This method is used to ensure a balance in sample size across groups over time.
Interventional model: parallel assignment Description: two different methods of screw and plate fixation of posterior wall acetabulum fractures.
Time perspective: Prospective
Population:
Skeletally mature patients who have presented with an acute traumatic fracture of the posterior wall of acetabulum due to dislocation of the femoral head will be included in this study. All surgeons on the study routinely perform both types of repairs.
Treatment arms and Intervention:
Arm A: Rim plate group - This group will consist of 30 patients where the posterior wall fracture will be operatively stabilized with a pelvic reconstruction plate and interfragmentary screws placed through the plate.
Arm B: Buttress plate group - This group will consist of 30 patients where the posterior wall fracture will be operatively fixed with a buttress plate applied under compression without interfragmentary lag or position screws.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The posterior wall fracture will be operatively stabilized with a pelvic reconstruction plate and interfragmentary screws placed through the plate.
The posterior wall fracture will be operatively fixed with a buttress plate applied under compression without interfragmentary lag or position screws.
Time frame: 12 months
Measured on immediate post-op CT and compared to measurement one year post-op
Time frame: 12 months
Measured on immediate post-op CT and compared to measurement one year post-op
Time frame: 12 months
Degree and extent of articular space loss (chondrolysis)
Time frame: 12 months
Evaluates pain, gait and mobility
Time frame: 12 months
Hip rating system
Time frame: 12 months
A system of highly reliable, precise measures of patient-reported health status for physical, mental, and social well-being
Time frame: 12 months
Measure the functional status of patients with a broad range of musculoskeletal injuries and disorders
Time frame: 12 months
Quantifies health status and measures health-related quality of life
Contact information is provided by the study sponsor or research team.
University of Cincinnati
Other
A Randomized Prospective Study Comparing Rim Plate to Buttress Plate for Posterior Wall Acetabular Fractures With and Without Inter-fragmentary Screws
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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