RCT Determining Best Treatment for Geriatric Acetabular Fractures
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 60 - 100 |
| Updated: | 3/15/2019 |
| Start Date: | April 13, 2011 |
| End Date: | April 30, 2020 |
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
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.
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.
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.
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.
Inclusion Criteria:
- Patients 60 years and older at the time of injury who have sustained an acetabular
fracture
- Fluent in the English Language
Exclusion Criteria:
- Patients under the Age of 60 years old
- Patients who are medically contraindicated for surgery
- Patients who in the surgeon's view will be unable to comply with posterior hip
precautions (to prevent dislocation) after surgery
- In patients with bilateral acetabular fractures, the most severe side will be
randomized into the study while the other side will be treated but not included in the
study.
- Open Injuries
We found this trial at
1
site
351 West Camden Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
Phone: 410-706-1604
Click here to add this to my saved trials
