RCT Determining Best Treatment for Geriatric Acetabular Fractures
Condition: Acetabular Fracture
MeSH terms: Fractures, Bone
Study type: Interventional

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.
    

Intervention name(s): Open Reduction internal Fixation; Open Reduction Internal Fixation with Total Hip Arthroscopy
Intervention type(s): Procedure; Procedure
Intervention description(s): A surgeon uses hardware, such as plates and screws, to restore structural integrity and alignment of an acetabular fracture.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized t wo treatment groups : 1. Open reduction internal fixation (ORIF) 2. Acute primary total hip athroplasty (THA) +ORIF. These are both two standard accepted treatments for this injury. Participants who do not consent to being randomized will be asked if they would consent to participating in an observational arm. In this case, type of surgery would be planned and chosen by clinical decision making from the surgeon and patient. As these procedures are both standard of care, partipants could end up in either group as well. All follow up will be the same.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Geriatric; Acetabular; Arthroplasty