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Trial record 4 of 5 for:    17538085 [PUBMED-IDS]

RCT Determining Best Treatment for Geriatric Acetabular Fractures (GeriTab)

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ClinicalTrials.gov Identifier: NCT03419182
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Theodore Manson, University of Maryland

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.

Condition or disease Intervention/treatment Phase
Acetabular Fracture Procedure: Open Reduction internal Fixation Procedure: Open Reduction Internal Fixation with Total Hip Arthroscopy Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
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)
Masking Description: The individual administering the WOMAC or SF-36 will be blinded to the patient's treatment arm.
Primary Purpose: Treatment
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
Actual Study Start Date : April 13, 2011
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Active Comparator: 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.
Procedure: Open Reduction internal Fixation
A surgeon uses hardware, such as plates and screws, to restore structural integrity and alignment of an acetabular fracture.

Active Comparator: 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.
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.

No Intervention: 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 Intervention: 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.



Primary Outcome Measures :
  1. The primary outcome measure for this study is the proportion of complications in the first 12 months following surgery [ Time Frame: 1 year ]

    Researchers will assess treatment success using a two-group comparison of proportion of complications between the treatment groups during the first 12 months following treatment.

    Complications will be identified by radiographic and clinical evaluation during standard follow-up appointments with the treating surgeon. Complications include postoperative infections, non-union, mal-union, development of heterotopic bone, development of osteoarthritis, osteolysis, hardware failure, hip dislocations, surgical revisions, and any other condition related to surgical treatment of the study injury.



Secondary Outcome Measures :
  1. A secondary outcome for this study is to evaluate patient reported outcomes using the WOMAC Questionnaire. [ Time Frame: 6 months and 12 months ]
    All enrolled patients complete WOMAC questionnaire 6 and 12 months after surgical treatment. Patient reported outcomes are based on scores on the WOMAC questionnaire. Using a mean of 50 and a standard deviation of 10, this study will have 80% power to detect a 10% change in the patient satisfaction questionnaire.

  2. A secondary outcome for this study is to evaluate patient reported outcomes using the SF36 Questionnaire. [ Time Frame: 6 months and 12 months ]
    All enrolled patients complete SF36 questionnaire 6 and 12 months after surgical treatment. Patient reported outcomes are based on scores on the SF36 questionnaire. Using a mean of 50 and a standard deviation of 10, this study will have 80% power to detect a 10% change in the patient satisfaction questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03419182


Contacts
Contact: Joshua S Rudnicki, BS 4107061604 JRudnicki@umoa.umm.edu
Contact: Yasmin Degani, MS 4107065917 Ydegani@umoa.umm.edu

Locations
United States, Maryland
University of Maryland Department of Orthopaedics Recruiting
Baltimore, Maryland, United States, 21201
Contact: Joshua S Rudnicki, BS    410-706-1604    JRudnicki@UMOA.UMM.EDU   
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Theodore Manson, MD Associate Professor of Orthopaedics

Publications:

Responsible Party: Theodore Manson, Associate Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT03419182     History of Changes
Other Study ID Numbers: HP-00047655
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Theodore Manson, University of Maryland:
Geriatric
Acetabular
Arthroplasty

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries