RCT Determining Best Treatment for Geriatric Acetabular Fractures (GeriTab)

February 15, 2022 updated by: Theodore Manson, University of Maryland, Baltimore

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Department of Orthopaedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months and 12 months
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.
6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Investigators

  • Principal Investigator: Theodore Manson, MD, Associate Professor of Orthopaedics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2011

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

September 22, 2017

First Submitted That Met QC Criteria

January 31, 2018

First Posted (Actual)

February 1, 2018

Study Record Updates

Last Update Posted (Actual)

March 3, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00047655

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acetabular Fracture

Clinical Trials on Open Reduction internal Fixation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe