Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Secondary Procedures and Quality of Life in Adults With Displaced Hip Fractures

NCT ID: NCT00556842

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1495 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2019-05-30

Brief Summary

Each year, hip fracture, an injury that can impair independence and quality of life, occurs in about 280,000 Americans and 36,000 Canadians. By the year 2040, the annual healthcare costs associated with hip fractures are expected to reach $9.8 billion in the United States and $650 million in Canada. It is important to have in place optimal practice guidelines for the surgical handling of this injury. One type of hip fracture, called a displaced femoral neck fracture, is often treated with a hip replacement surgery. Patients undergoing a hip replacement may receive either a total hip replacement, in which the head of the femur and the hip joint socket are replaced, or a partial hip replacement, in which only the head of the femur is replaced. This study will compare the two different hip replacement procedures to determine which one results in better outcomes after surgery in adults aged 50 and older.

Detailed Description

One type of hip fracture, called a femoral neck fracture, involves a break in the narrow part of the femur bone where the head of the femur is joined to the main shaft. The break can be either undisplaced, which involves very little separation at the fracture site, or displaced, in which there is substantial separation. For displaced fractures, surgeons usually choose between internal fixation and hip arthroplasty, which is also known as hip replacement.

Patients receiving hip arthroplasty may undergo either a total hip arthroplasty or a hemi-arthroplasty. Which surgical method is best for the patient is unknown. Advocates of total hip replacement claim better improvements in patient function and quality of life. On the other hand, advocates of hemi-arthroplasty, which include most orthopaedic surgeons, claim reduced rates of dislocation and deep vein thrombosis, shorter operating times, less blood loss, and a technically less demanding surgical procedure. This study will compare total hip arthroplasty and hemi-arthroplasty on rates of revision surgery 2 years after patients aged 50 and older sustain femoral neck fractures and undergo surgery. The study will also compare the impact of the two different surgical procedures on function, quality of life, and post-surgical complications. Results from this study may impact current orthopaedic practice.

Participation in this study will last 2 years. Before surgery, participants will complete a baseline assessment that will include x-rays, a medical history review, and a physical examination. Participants will then be randomly assigned to undergo either total hip arthroplasty or hemi-arthroplasty to repair their hip fractures. All surgeons will need to meet certain criteria to partake in the study and will have expertise in whichever surgical procedure they are performing. Surgeons will also follow the manufacturers' implant guidelines during surgery. Specific aspects of both the preoperative and post-operative care, such as weight bearing status, the prevention of thromboembolic disease, and the use of antibiotics and calcium supplementation, will be standardized for all participants. Within 2 days of under going surgery, x-rays will be performed again.

Follow-up assessments will be completed either by phone or in-person at the hospital or clinic. They will occur 1 and 10 weeks after surgery and 6, 9, 12, 18, and 24 months after surgery. All assessments will include questionnaires and interviews on health status, hip function, pain, functional mobility, and revision surgery. Some of the in-person assessments will also include x-rays.

Conditions

Hip Fractures; Femoral Neck Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Participants will undergo total hip arthroplasty.

Group Type: ACTIVE_COMPARATOR

Total hip arthroplasty

Intervention Type: DEVICE

Proscribed approaches will include minimally invasive total hip arthroplasty (i.e., two incision approaches) and hinged prostheses or capture cups. Other surgical approach aspects, the use of cemented components, the implant manufacturer, and femoral head size will not be standardized. Surgeons will use the manufacturers' specific implant guidelines for insertion.

2

Participants will undergo hemi-arthroplasty.

Group Type: ACTIVE_COMPARATOR

Hemi-arthroplasty

Intervention Type: DEVICE

Surgeons will use modern implants for hemi-arthroplasty, excluding non-modular, non-canal filling unipolar implants such as Moore's and Thompson's prostheses. The choice of modular unipolar versus bipolar hemi-arthroplasty will not be standardized. Whether implants are inserted with cement or a press-fit design will also not be standardized. Surgeons will use the manufacturers' specific implant guidelines for insertion.

Interventions

Total hip arthroplasty

Proscribed approaches will include minimally invasive total hip arthroplasty (i.e., two incision approaches) and hinged prostheses or capture cups. Other surgical approach aspects, the use of cemented components, the implant manufacturer, and femoral head size will not be standardized. Surgeons will use the manufacturers' specific implant guidelines for insertion.

Intervention Type: DEVICE

Hemi-arthroplasty

Surgeons will use modern implants for hemi-arthroplasty, excluding non-modular, non-canal filling unipolar implants such as Moore's and Thompson's prostheses. The choice of modular unipolar versus bipolar hemi-arthroplasty will not be standardized. Whether implants are inserted with cement or a press-fit design will also not be standardized. Surgeons will use the manufacturers' specific implant guidelines for insertion.

Intervention Type: DEVICE

Other Intervention Names

THA; HA

Eligibility Criteria

Inclusion Criteria

• Adult men or women aged 50 years and old (with no upper age limit)
• Fracture of the femoral neck, as confirmed with either anteroposterior or lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI)
• Displaced fracture that is not, in the judgment of the attending surgeon, optimally managed by reduction and internal fixation
• Operative treatment is planned within 72 hours of the patient being medically cleared for surgery
• Patient was ambulatory prior to the fracture, though they may have used an aid such as a cane or a walker
• Anticipated medical optimization for arthroplasty of the hip
• Provision of informed consent by patient or proxy
• Low energy fracture (defined as a fall from standing height), with no other trauma
• Assurance from site that surgeons with expertise in both total hip arthroplasty and hemi-arthroplasty are available to perform surgery (Note: Surgeons do not need to be experts in both techniques)

Exclusion Criteria

• Not suitable for hemi-arthroplasty (i.e., inflammatory arthritis, rheumatoid arthritis, pathologic fractures (secondary to cancer), or severe osteoarthritis of the hip)
• Associated major injuries of the lower extremity (e.g., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture)
• Retained hardware around the affected hip that will interfere with arthroplasty
• Infection around the hip (soft tissue or bone)
• Bone metabolism disorder except osteoporosis (e.g., Paget's disease, renal osteodystrophy, osteomalacia)
• Patients with a previous history of frank dementia that would interfere with the assessment of primary outcome (e.g., secondary procedures at 2 years).
• Likely problems, in the judgment of the investigators, with maintaining follow-up (e.g., no fixed address, plans to move out of town in the next year, or intellectually challenged and without adequate family support)
• Enrolled in another ongoing drug or surgical intervention trial
• Patients whose fracture occurred as a result of violence.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

Sophies Minde Ortopedi

INDUSTRY

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohit Bhandari, MD PhD FRCSC

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Thomas A. Eihnorn, MD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

New York University Medical Center

New York, New York, United States

McMaster University

Hamilton, Ontario, Canada

Countries

United States; Canada

References

Hebert-Davies J, Laflamme GY, Rouleau D; HEALTH and FAITH investigators. Bias towards dementia: are hip fracture trials excluding too many patients? A systematic review. Injury. 2012 Dec;43(12):1978-84. doi: 10.1016/j.injury.2012.08.061. Epub 2012 Sep 19.

Reference Type: BACKGROUND

PMID: 22999009 (View on PubMed)

Burgers PT, Van Geene AR, Van den Bekerom MP, Van Lieshout EM, Blom B, Aleem IS, Bhandari M, Poolman RW. Total hip arthroplasty versus hemiarthroplasty for displaced femoral neck fractures in the healthy elderly: a meta-analysis and systematic review of randomized trials. Int Orthop. 2012 Aug;36(8):1549-60. doi: 10.1007/s00264-012-1569-7. Epub 2012 May 24.

Reference Type: BACKGROUND

PMID: 22623062 (View on PubMed)

Burgers PT, Hoogendoorn M, Van Woensel EA, Poolman RW, Bhandari M, Patka P, Van Lieshout EM; HEALTH Trial Investigators. Total medical costs of treating femoral neck fracture patients with hemi- or total hip arthroplasty: a cost analysis of a multicenter prospective study. Osteoporos Int. 2016 Jun;27(6):1999-2008. doi: 10.1007/s00198-016-3484-z. Epub 2016 Jan 28.

Reference Type: BACKGROUND

PMID: 26821137 (View on PubMed)

Bhandari M, Devereaux PJ, Einhorn TA, Thabane L, Schemitsch EH, Koval KJ, Frihagen F, Poolman RW, Tetsworth K, Guerra-Farfan E, Madden K, Sprague S, Guyatt G; HEALTH Investigators. Hip fracture evaluation with alternatives of total hip arthroplasty versus hemiarthroplasty (HEALTH): protocol for a multicentre randomised trial. BMJ Open. 2015 Feb 13;5(2):e006263. doi: 10.1136/bmjopen-2014-006263.

Reference Type: BACKGROUND

PMID: 25681312 (View on PubMed)

Burgers PT, Poolman RW, Van Bakel TM, Tuinebreijer WE, Zielinski SM, Bhandari M, Patka P, Van Lieshout EM; HEALTH and FAITH Trial Investigators. Reliability, validity, and responsiveness of the Western Ontario and McMaster Universities Osteoarthritis Index for elderly patients with a femoral neck fracture. J Bone Joint Surg Am. 2015 May 6;97(9):751-7. doi: 10.2106/JBJS.N.00542.

Reference Type: BACKGROUND

PMID: 25948522 (View on PubMed)

HEALTH Investigators; Bhandari M, Einhorn TA, Guyatt G, Schemitsch EH, Zura RD, Sprague S, Frihagen F, Guerra-Farfan E, Kleinlugtenbelt YV, Poolman RW, Rangan A, Bzovsky S, Heels-Ansdell D, Thabane L, Walter SD, Devereaux PJ. Total Hip Arthroplasty or Hemiarthroplasty for Hip Fracture. N Engl J Med. 2019 Dec 5;381(23):2199-2208. doi: 10.1056/NEJMoa1906190. Epub 2019 Sep 26.

Reference Type: DERIVED

PMID: 31557429 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

UM1AR063386

Identifier Type: NIH

Identifier Source: secondary_id

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1R01AR055130-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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MOP 126188

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

UM1AR063386-01

Identifier Type: NIH

Identifier Source: org_study_id

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