Acetabular Fracture
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPelvic reconstruction plate without interfragmentary screws
The posterior wall fracture will be operatively stabilized with a pelvic reconstruction plate and interfragmentary screws placed through the plate.
DEVICEPelvic reconstruction plate with interfragmentary screws
The posterior wall fracture will be operatively fixed with a buttress plate applied under compression without interfragmentary lag or position screws.
Sponsors
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel assignment to two different methods of screw and plate fixation of posterior wall acetabulum fractures.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Skeletally mature males and females, ≥ 18 years old and with age less than 65 years. 2. Fracture of the acetabular posterior wall fracture due to acute traumatic hip dislocation, confirmed with anteroposterior pelvic or hip radiographs, and CT scan 3. Operative fixation of fractures within 14 days of presenting to the emergency room. 4. Patient was ambulatory prior to fracture, with or without walking aids 5. Medically optimized for operative intervention 6. Provision of informed consent by patient or legal guardian.
Exclusion criteria
1. Patients not suitable for internal fixation (severe osteoarthritis, rheumatoid arthritis, or pathologic fracture). 2. Pre-existing orthopedic fixation, implant, or prosthesis around the affected acetabulum. 3. Patients with metabolic bone disease including diagnosis of osteoporosis. 4. Patients with bony or soft tissue infections around the acetabulum. 5. Patients unable to provide informed consent. 6. Patients having other fractures of Pelvis or acetabulum other than an isolated posterior acetabular wall fracture. 7. Patients with previous history of acetabular fracture (operative or nonoperative) 8. Patients with previous history of hip pathology such as avascular necrosis, hip dysplasia, Legg-Calve Perthes Disease, or advanced degenerative arthritis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Displacement of posterior wall acetabular fragment | 12 months | Measured on immediate post-op CT and compared to measurement one year post-op |
| Healing of the posterior wall fragment | 12 months | Measured on immediate post-op CT and compared to measurement one year post-op |
| Articular space loss | 12 months | Degree and extent of articular space loss (chondrolysis) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Merle d'Aubigne score | 12 months | Evaluates pain, gait and mobility |
| IOWA hip score | 12 months | Hip rating system |
| PROMIS-10 score | 12 months | A system of highly reliable, precise measures of patient-reported health status for physical, mental, and social well-being |
| SMFA score | 12 months | Measure the functional status of patients with a broad range of musculoskeletal injuries and disorders |
| SF 36 score | 12 months | Quantifies health status and measures health-related quality of life |
Countries
United States
Contacts
CONTACTKimberly A Hasselfeld
Outcome results
None listed