RCT Determining Best Treatment for Geriatric Acetabular Fractures

NCT03419182 | Completed

• 1 other identifier: HP-00047655
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Acetabular Fracture

Keywords

Geriatric; Acetabular; Arthroplasty

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure for this study is the proportion of complications in the first 12 months following surgery

  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 Outcomes (2)

• A secondary outcome for this study is to evaluate patient reported outcomes using the WOMAC Questionnaire.

  6 months and 12 months

• A secondary outcome for this study is to evaluate patient reported outcomes using the SF36 Questionnaire.

  6 months and 12 months

Study Arms (4)

RCT - ORIF

ACTIVE COMPARATOR

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

RCT - (THA) + ORIF

ACTIVE COMPARATOR

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

OBS - ORIF

NO INTERVENTION

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.

OBS (THA) + ORIF

NO INTERVENTION

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.

Interventions

Open Reduction internal Fixation PROCEDURE

A surgeon uses hardware, such as plates and screws, to restore structural integrity and alignment of an acetabular fracture.

RCT - ORIF

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.

RCT - (THA) + ORIF

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 60 years and older at the time of injury who have sustained an acetabular fracture
• Fluent in the English Language

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Department of Orthopaedics

Baltimore, Maryland, 21201, United States

Location

Related Publications (33)

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Study Officials

• Theodore Manson, MD

  Associate Professor of Orthopaedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The individual administering the WOMAC or SF-36 will be blinded to the patient's treatment arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: February 1, 2018
• Study Start: April 13, 2011
• Primary Completion: March 1, 2020
• Study Completion: April 1, 2020
• Last Updated: March 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)