RCT Determining Best Treatment for Geriatric Acetabular Fractures

Acetabular Fracture Clinical Trial

— GeriTab  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03419182
• Other study ID #: HP-00047655
• Status: Completed
• Phase: N/A
• Start date: April 13, 2011
• Est. completion date: April 1, 2020

Study information

• Verified date: February 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: April 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Acetabular Fracture
• Fractures, Bone

Intervention

Procedure:
• Open Reduction internal Fixation
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
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.

Locations

Country	Name	City	State
United States	University of Maryland Department of Orthopaedics	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

References & Publications (33)

Anglen JO, Burd TA, Hendricks KJ, Harrison P. The "Gull Sign": a harbinger of failure for internal fixation of geriatric acetabular fractures. J Orthop Trauma. 2003 Oct;17(9):625-34. — View Citation

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Manson TT, Nascone JW, Sciadini MF, O'Toole RV. Does fracture pattern predict death with lateral compression type 1 pelvic fractures? J Trauma. 2010 Oct;69(4):876-9. doi: 10.1097/TA.0b013e3181e785bf. — View Citation

Manson TT, Perdue PW, Pollak AN, O'Toole RV. Embolization of pelvic arterial injury is a risk factor for deep infection after acetabular fracture surgery. J Orthop Trauma. 2013 Jan;27(1):11-5. doi: 10.1097/BOT.0b013e31824d96f6. — View Citation

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Mouhsine E, Garofalo R, Borens O, Fischer JF, Crevoisier X, Pelet S, Blanc CH, Leyvraz PF. Acute total hip arthroplasty for acetabular fractures in the elderly: 11 patients followed for 2 years. Acta Orthop Scand. 2002 Dec;73(6):615-8. — View Citation

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Shah SB, Manson TT, Nascone JW, Sciadini MF, O'Toole RV. Radiographic Determinants of Early Failure After Posterior Wall Acetabular Fracture Fixation. Orthopedics. 2016 Nov 1;39(6):e1104-e1111. doi: 10.3928/01477447-20160819-03. Epub 2016 Aug 30. — View Citation

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Walley KC, Appleton PT, Rodriguez EK. Comparison of outcomes of operative versus non-operative treatment of acetabular fractures in the elderly and severely comorbid patient. Eur J Orthop Surg Traumatol. 2017 Jul;27(5):689-694. doi: 10.1007/s00590-017-1949-1. Epub 2017 Apr 7. — View Citation

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	A secondary outcome for this study is to evaluate patient reported outcomes using the WOMAC Questionnaire.	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
Secondary	A secondary outcome for this study is to evaluate patient reported outcomes using the SF36 Questionnaire.	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