Geriatric Acetabular fracTures: Open Reduction Internal Fixation Versus Replacement

NCT03713853 | Recruiting DMC

• 1 other identifier: 18-0303
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Management of acetabular (hip) fractures in the geriatric population can be very challenging because of pre-existing medical comorbidities, pre-existing osteoporosis and increased risk of mortality. The two most common treatment options for acetabular fractures are either surgical fixation using plates and screws to hold the fractured pieces in the correct position until the fracture has healed or surgical fixation in addition to a total hip replacement. Surgical fixation requires prolonged immobilization of the affected limb (typically around 6-12 weeks post-operatively), which can lead to disability and other complications. Such patients, especially those who are frail and cognitively impaired, are unable to adhere to the immobilization restrictions, leading to an increased risk of fixation failure. Patients who underwent open reduction internal fixation (ORIF) of an acetabular fracture were reported to have about 25 times greater incidence of hip replacement compared with general population matched controls. Additionally, performing a subsequent hip replacement after a previous surgical fixation (ORIF) of an acetabular fracture, especially in the elderly population, can present a number of technical difficulties including; difficult dissection due to previous incision(s) and scarring, dealing with retained hardware, bony deficiency and the possibility of infected hardware. The aim of the study is to perform a large cohort study to assess pain and physical function in patients 60 years and older who have sustained an acetabular fracture.

Conditions

Acetabular Fracture

Keywords

Total hip replacement; Total hip arthroplasty; Open Reduction internal Fixation; Hip fixation

Outcome Measures

Primary Outcomes (1)

• Oxford Hip score

  Oxford Hip Score is a short 12-item patient-reported outcome specifically designed and developed to assess function and pain during short-term and long-term follow-up for hip osteoarthritis and hip replacement surgery. It is valid, reliable, reproducible, and sensitive to clinically important changes. An increase in score indicate better joint function. A score between 40-48 indicates satisfactory joint function.

  Questionnaire will be completed by patients at 3, 6 and 12-months follow-up and repeated measures analysis will be performed to assess the change across all time points (3,6 and 12-months)

Secondary Outcomes (9)

• Timed Up and Go (TUG) test

  Test will be completed at 3, 6,12 and 24-months follow-up

• Visual Analogue Scale of pain (VAS)

  Patients will indicate their pain level at 24, 48 hours, 6 weeks, 3, 6,12 and 24-months after surgery

• Total Morphine Equivalents Usage

  The outcome will be assessed daily from the day of the surgery until the patient gets discharge from the hospital (24 hours up to 7 days)

• Health status and quality of life

  Questionnaire will be completed by patients at 6 weeks, 3, 6, 12 and 24-months follow-up

• Length of hospital stay

  The outcome will be assessed from the day of the surgery until the patient gets discharge from the hospital (at a maximum of 30 days after the surgery)

Study Arms (2)

Total hip arthroplasty + ORIF

Patients will receive acute primary total hip arthroplasty (THA) with open reduction internal fixation (ORIF) as a treatment for their acetabular fracture

Surgical Fixation (ORIF)

Patients will receive open reduction internal fixation (ORIF) as a treatment for their acetabular fracture

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients 60 years of age and older, presenting at the participant hospital sites with a displaced acetabular fracture and who need surgery to fix their fracture, either total hip replacement (THA) together with surgical fixation (ORIF) or surgical fixation (ORIF) alone, will be screened for the study. Patients who meet the trial eligibility criteria will be approached by a member of the research team. The study will be explained in detail and written informed consent will be undertaken with those patients who wish to participate in the study. Outcomes for participants will be measured and captured during regularly scheduled clinic/hospital visits

You may qualify if:

• years of age or older
• Isolated and Displaced (more or equal to 2mm on any radiographic view) fracture of the acetabulum
• Patient requires surgical treatment, either THA+ORIF or ORIF surgeries
• Fracture is acute (within 3 weeks of injury)
• Patient was ambulatory (with or without walking aids) prior to their acetabular fracture injury
• Patient is able to provide informed consent to participation in the study
• Patient is able to read and understand English

You may not qualify if:

• Presence of an active or chronic infection around the fracture (soft tissue or bone)
• Open/compound fracture
• Bilateral acetabular fractures
• Pathological fracture excluding osteoporosis
• Periprosthetic fracture (previous arthroplasty or hardware or ORIF in-situ). Hardware (screws or plates or nails or hemi-arthroplasty) on the femoral side are not excluded.
• Medical or surgical contraindication to surgery
• Dementia

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

Unity Health Toronto - St Michael's Hospital

Toronto, Ontario, M5C 1R6, Canada

RECRUITING

Related Publications (11)

• Cahueque M, Martinez M, Cobar A, Bregni M. Early reduction of acetabular fractures decreases the risk of post-traumatic hip osteoarthritis? J Clin Orthop Trauma. 2017 Oct-Dec;8(4):320-326. doi: 10.1016/j.jcot.2017.01.001. Epub 2017 Jan 13.

  PMID: 29062212 BACKGROUND

• Firoozabadi R, Cross WW, Krieg JC, Routt MLC. Acetabular Fractures in the Senior Population- Epidemiology, Mortality and Treatments. Arch Bone Jt Surg. 2017 Mar;5(2):96-102.

  PMID: 28497099 BACKGROUND

• Boelch SP, Jordan MC, Meffert RH, Jansen H. Comparison of open reduction and internal fixation and primary total hip replacement for osteoporotic acetabular fractures: a retrospective clinical study. Int Orthop. 2017 Sep;41(9):1831-1837. doi: 10.1007/s00264-016-3260-x. Epub 2016 Aug 10.

  PMID: 27511470 BACKGROUND

• Hanschen M, Pesch S, Huber-Wagner S, Biberthaler P. Management of acetabular fractures in the geriatric patient. SICOT J. 2017;3:37. doi: 10.1051/sicotj/2017026. Epub 2017 May 25.

  PMID: 28534471 BACKGROUND

• Morison Z, Moojen DJ, Nauth A, Hall J, McKee MD, Waddell JP, Schemitsch EH. Total Hip Arthroplasty After Acetabular Fracture Is Associated With Lower Survivorship and More Complications. Clin Orthop Relat Res. 2016 Feb;474(2):392-8. doi: 10.1007/s11999-015-4509-1.

  PMID: 26335343 BACKGROUND

• Khurana S, Nobel TB, Merkow JS, Walsh M, Egol KA. Total Hip Arthroplasty for Posttraumatic Osteoarthritis of the Hip Fares Worse Than THA for Primary Osteoarthritis. Am J Orthop (Belle Mead NJ). 2015 Jul;44(7):321-5.

  PMID: 26161760 BACKGROUND

• Henry PDG, Si-Hyeong Park S, Paterson JM, Kreder HJ, Jenkinson R, Wasserstein D. Risk of Hip Arthroplasty After Open Reduction Internal Fixation of a Fracture of the Acetabulum: A Matched Cohort Study. J Orthop Trauma. 2018 Mar;32(3):134-140. doi: 10.1097/BOT.0000000000001048.

  PMID: 29462122 BACKGROUND

• O'Toole RV, Hui E, Chandra A, Nascone JW. How often does open reduction and internal fixation of geriatric acetabular fractures lead to hip arthroplasty? J Orthop Trauma. 2014 Mar;28(3):148-53. doi: 10.1097/BOT.0b013e31829c739a.

  PMID: 23719343 BACKGROUND

• Weaver MJ, Smith RM, Lhowe DW, Vrahas MS. Does Total Hip Arthroplasty Reduce the Risk of Secondary Surgery Following the Treatment of Displaced Acetabular Fractures in the Elderly Compared to Open Reduction Internal Fixation? A Pilot Study. J Orthop Trauma. 2018 Feb;32 Suppl 1:S40-S45. doi: 10.1097/BOT.0000000000001088.

  PMID: 29373451 BACKGROUND

• Hamlin K, Lazaraviciute G, Koullouros M, Chouari T, Stevenson IM, Hamilton SW. Should Total Hip Arthroplasty be Performed Acutely in the Treatment of Acetabular Fractures in Elderly or Used as a Salvage Procedure Only? Indian J Orthop. 2017 Jul-Aug;51(4):421-433. doi: 10.4103/ortho.IJOrtho_138_16.

  PMID: 28790471 BACKGROUND

• Ortega-Briones A, Smith S, Rickman M. Acetabular Fractures in the Elderly: Midterm Outcomes of Column Stabilisation and Primary Arthroplasty. Biomed Res Int. 2017;2017:4651518. doi: 10.1155/2017/4651518. Epub 2017 Jan 17.

  PMID: 28194414 BACKGROUND

Study Officials

• Amir Khoshbin, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cassandra Tardif-Theriault, BKin

CONTACT

4168646060; cassandra.tardif-theriault@unityhealth.to

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 22, 2018
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

CA (1)