NCT03419182

RCT Determining Best Treatment for Geriatric Acetabular Fractures

Randomized Controlled Trial to Determine the Best Treatment of Acetabular Fractures in Geriatric Patients: Open Reduction Internal Fixation With or Without Primary Total Hip Arthroplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 60 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

There is debate over the best management for acetabular (hip) fractures that occur within the geriatric population. Geriatric patients, 60 years or older, are at greater risk for operative complications because they tend to have poorer bone quality, complicated fractures, and multiple health problems. Physicians currently have no guidelines as to the best surgical management for these particular fractures, because there is little data on the long-term outcomes of these injuries. The use of internal fixation (a nail or plate) is a standard method for repairing these injuries, however when the injuries are complicated it is predicted to have a poorer outcome than performing internal fixation along with total hip arthroplasty (joint reconstruction). Given the significant problems that result from hip fractures in this population, our study is designed to determine the best method for treatment of acetabular fractures and to clarify the criteria for treatment with guidelines assisting the physician in selecting the appropriate treatment.

Detailed description

This is a pilot randomized controlled study conducted at Shock Trauma and University of Maryland Medical Center of patients 60 years and older who have sustained an acetabular fracture. Based on the patient's fracture pattern, dome impaction, posterior wall component and femoral head fracture, the patients will be randomized to their treatment arm. One treatment arm will consist of patients who are treated with ORIF alone. The other treatment will undergo ORIF as well as concomitant total hip arthroplasty in the same surgery. Furthermore the functional status evaluation of each patient will be standardized using the WOMAC (Western Ontario McMaster Universities OA index), a lower extremity specific outcome score that has been validated for use in patients of similar age to our cohort study in osteoarthritis or after total hip arthroplasty; and the SF-36 (Short Form-36) which is a validated general health outcome measure that calculates mental and physical subcomponent scores. Patients will also be assessed using the Harris Hip Score, which has been used for patients with post-traumatic arthritis undergoing conversion to total hip arthroplasty. All patients will be followed as standard of care for their follow up visits at 6 month and 1 year. As the patient population at Shock Trauma and University of Maryland Medical Center are all treated by the same orthopaedic group, one dedicated investigator will follow their outcomes. To minimize the risk of bias, I, the individual administering the WOMAC or SF-36 will be blinded to the patient's treatment arm. As the patient will be giving consent for their treatment, they cannot be blinded. Also, the surgeons (and the research coordinator) will know which group the patient is in, but the investigator collecting the data will not.

Conditions

• Acetabular Fracture

Interventions

Type	Name	Description
PROCEDURE	Open Reduction internal Fixation	A surgeon uses hardware, such as plates and screws, to restore structural integrity and alignment of an acetabular fracture.
PROCEDURE	Open Reduction Internal Fixation with Total Hip Arthroscopy	A surgeon uses hardware, such as plates and screws, to restore structural integrity and alignment of an acetabular fracture, and replaces the cartilage and bone of the greater trochanter with prosthetic components.

Timeline

• Start date: 2011-04-13
• Primary completion: 2020-03-01
• Completion: 2020-04-01
• First posted: 2018-02-01
• Last updated: 2022-03-03

Locations

1 site across 1 country: United States