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

NCT00556842 | Completed Results DMC

• 4 other identifiers: UM1AR063386-01UM1AR0633861R01AR055130-01A1MOP 126188
• Study Type: interventional
• Target: 1,495
• Locations: 2 countries
• Sites: 2

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.

Conditions

Hip Fractures; Femoral Neck Fractures

Keywords

Hemi-Arthroplasty; Total Hip Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Revision Surgery

  The primary outcome is any unplanned secondary procedure within 2 years of the initial joint replacement surgery.

  Measured 2 years after original surgery

Secondary Outcomes (5)

• Hip Function and Pain

  Measured 2 years after original surgery

• Number of Participants With Functional Mobility Problems

  Measured 2 years after original surgery

• Health-Related Quality of Life (SF-12)

  Measured 2 years after original surgery

• Health-Related Quality of Life (EQ-5D)

  Measured 2 years after original surgery

• Complications, Including Mortality, Dislocation, Infection, Femoral Fracture, Deep Venous Thrombosis, and Prosthesis Loosening

  Measured 2 years after original surgery

Study Arms (2)

1

ACTIVE COMPARATOR

Participants will undergo total hip arthroplasty.

Device: Total hip arthroplasty

2

ACTIVE COMPARATOR

Participants will undergo hemi-arthroplasty.

Device: Hemi-arthroplasty

Interventions

Total hip arthroplasty 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.

Also known as: THA

1

Hemi-arthroplasty 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.

Also known as: HA

2

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• Hamilton Health Sciences Corporation: collaborator
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Sophies Minde Ortopedi: collaborator

Study Sites (2)

New York University Medical Center

New York, New York, 10003, United States

Location

McMaster University

Hamilton, Ontario, L8S4L8, Canada

Location

Related Publications (6)

• 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.

  PMID: 22999009 BACKGROUND

• 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.

  PMID: 22623062 BACKGROUND

• 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.

  PMID: 26821137 BACKGROUND

• 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.

  PMID: 25681312 BACKGROUND

• 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.

  PMID: 25948522 BACKGROUND

• 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.

  PMID: 31557429 DERIVED

MeSH Terms

Conditions

Hip Fractures; Femoral Neck Fractures

Interventions

Arthroplasty, Replacement, Hip; Hemiarthroplasty

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Limitations and Caveats

Patients and end-point assessors were unblinded in the assessments of function. Loss to follow-up was 14.9% for the final analysis. Data on function were incomplete; 82.9% of patients completed at least one questionnaire over 24 months.

Results Point of Contact

• Title: Paula McKay
• Organization: The Centre for Evidence-Based Orthopaedics

mckayp@mcmaster.ca

905-521-2100

Study Officials

• Mohit Bhandari, MD PhD FRCSC

  McMaster University

  PRINCIPAL INVESTIGATOR

• Thomas A. Eihnorn, MD

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2007
• First Posted: November 12, 2007
• Study Start: March 1, 2009
• Primary Completion: May 30, 2019
• Study Completion: May 30, 2019
• Last Updated: July 7, 2020
• Results First Posted: July 7, 2020

Record last verified: 2019-11

Locations

CA (1); US (1)