RCT Determining Best Treatment for Geriatric Acetabular Fractures
NCT ID: NCT03419182
Last Updated: 2022-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
53 participants
INTERVENTIONAL
2011-04-13
2020-04-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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RCT - ORIF
A patient in this study arm consents to randomization and receives RCT - ORIF as his/her treatment assignment. He/she will have his/her acetabular fracture treated by open reduction internal fixation.
Open Reduction internal Fixation
A surgeon uses hardware, such as plates and screws, to restore structural integrity and alignment of an acetabular fracture.
RCT - (THA) + ORIF
A patient in this study arm consents to randomization and receives RCT - (THA) + ORIF as his/her treatment assignment. He/she will have his/her acetabular fracture treated by open reduction internal fixation with primary total hip arthroplasty.
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.
OBS - ORIF
A patient in this study arm does not consent to randomization, but does agree to be involved in the observational study. He/she decides, with input from his/her surgeon, to have his/her acetabular fracture treated by open reduction internal fixation.
No interventions assigned to this group
OBS (THA) + ORIF
A patient in this study arm does not consent to randomization, but does agree to be involved in the observational study. He/she decides, with input from his/her surgeon, to have his/her acetabular fracture treated by open reduction internal fixation with primary total hip arthroplasty.
No interventions assigned to this group
Interventions
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Open Reduction internal Fixation
A surgeon uses hardware, such as plates and screws, to restore structural integrity and alignment of an acetabular fracture.
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.
Eligibility Criteria
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Inclusion Criteria
* Fluent in the English Language
Exclusion Criteria
* 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
60 Years
100 Years
ALL
No
Sponsors
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University of Maryland, Baltimore
OTHER
Responsible Party
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Theodore Manson
Associate Professor
Principal Investigators
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Theodore Manson, MD
Role: PRINCIPAL_INVESTIGATOR
Associate Professor of Orthopaedics
Locations
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University of Maryland Department of Orthopaedics
Baltimore, Maryland, United States
Countries
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References
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Other Identifiers
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HP-00047655
Identifier Type: -
Identifier Source: org_study_id
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