About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Skeletally mature males and females, ≥ 18 years old and with age less than 65 years.
Fracture of the acetabular posterior wall fracture due to acute traumatic hip dislocation, confirmed with anteroposterior pelvic or hip radiographs, and CT scan
Operative fixation of fractures within 14 days of presenting to the emergency room.
Patient was ambulatory prior to fracture, with or without walking aids
Disqualifiers
Patients not suitable for internal fixation (severe osteoarthritis, rheumatoid arthritis, or pathologic fracture).
Pre-existing orthopedic fixation, implant, or prosthesis around the affected acetabulum.
Patients with metabolic bone disease including diagnosis of osteoporosis.
Patients with bony or soft tissue infections around the acetabulum.
Trial design
Parallel
Treatments tested in this trial
Pelvic reconstruction plate without interfragmentary screws
DeviceThe posterior wall fracture will be operatively stabilized with a pelvic reconstruction plate and interfragmentary screws placed through the plate.
Pelvic reconstruction plate with interfragmentary screws
DeviceThe posterior wall fracture will be operatively fixed with a buttress plate applied under compression without interfragmentary lag or position screws.
Treatment groups
Trial outcomes
Primary outcomes
Displacement of posterior wall acetabular fragment
Measured on immediate post-op CT and compared to measurement one year post-op
Healing of the posterior wall fragment
Measured on immediate post-op CT and compared to measurement one year post-op
Articular space loss
Degree and extent of articular space loss (chondrolysis)
Secondary outcomes
Modified Merle d'Aubigne score
Evaluates pain, gait and mobility
IOWA hip score
Hip rating system
PROMIS-10 score
A system of highly reliable, precise measures of patient-reported health status for physical, mental, and social well-being
SMFA score
Measure the functional status of patients with a broad range of musculoskeletal injuries and disorders
Sponsors and contacts
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