Ignite Creation Date:
2024-05-06 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03419182
Status:
COMPLETED
Last Update Posted:
2022-03-03
First Post:
2017-09-22
Brief Title:
RCT Determining Best Treatment for Geriatric Acetabular Fractures
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
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
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GeriTab
Brief 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 patients 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 patients 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
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None