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Completed

NCT Number: NCT03419182

RCT Determining Best Treatment for Geriatric Acetabular Fractures

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.

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Key information

Conditions

Acetabular Fracture

Age range

60 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland Department of Orthopaedics

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Open reduction internal fixation

Procedure

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

Procedure

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study 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

Acronym: GeriTab

Important dates

Study start
2011
Primary completion
2020
Study completion
2020
First posted
Feb 1, 2018
Registry last updated
Mar 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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