Hip FracturesHEALTHNCT00556842
Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Secondary Procedures and Quality of Life in Adults With Displaced Hip Fractures
A study testing Total hip arthroplasty and Hemi-arthroplasty in people with Hip Fractures and Femoral Neck Fractures, run by McMaster University at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hip Fractures, Femoral Neck Fractures
- What is being tested?
- Total hip arthroplasty and Hemi-arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,495 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2009to 30 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- 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).
Show all 9Show fewer
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
New York University Medical Center
New York, New York, 10003
About this study
Official title: Hip Fracture Evaluation With Alternatives of Total Hip Arthroplasty Versus Hemi-Arthroplasty: A Multi-Centre Randomized Trial Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Secondary Procedures and Quality of Life in Patients With Displaced Femoral Neck Fractures
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.
Read the 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
- Being tested
- Total hip arthroplasty, Hemi-arthroplasty
- Keywords
- Hemi-Arthroplasty, Total Hip Arthroplasty
- Medical subject headings
- Hip Fractures, Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip arthroplastyDevice
Also called THA
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.
Hemi-arthroplastyDevice
Also called HA
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Participants will undergo total hip arthroplasty. Receives: Device: Total hip arthroplasty |
| 2 | Active comparator | Participants will undergo hemi-arthroplasty. Receives: Device: Hemi-arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Revision Surgery
The primary outcome is any unplanned secondary procedure within 2 years of the initial joint replacement surgery.
Measured: Measured 2 years after original surgery
Secondary outcomes (5)
Hip Function and Pain
Hip function and pain were measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), which is a self-administered questionnaire that assesses 3 dimensions of pain, disability, joint stiffness in knee and hip osteoarthritis. This questionnaire uses a Likert scale, with the responses: none, mild, moderate, severe, and extreme. A higher score indicates worse pain, stiffness, and functional limitations. The ranges are: 0-20 for pain, 0-8 for stiffness, 0-68 for physical function. The sum of the pain, stiffness, and physical function subscales provides the WOMAC total score, which ranges from 0-96.
Measured: Measured 2 years after original surgery
Number of Participants With Functional Mobility Problems
Functional outcome measured using the Timed Up and Go (TUG) test. The TUG test is a standardized, physical test to assess balance and mobility in the participants. The participant is timed while they perform simple physical movements, such as rising from an arm chair, walking 10 feet, walking back to the chair, and sitting down. A faster time indicates that the participant has greater functional performance, while a lower score may identify participants who are at risk for increased falls in the community.
We analyzed the TUG as a dichotomous outcome with the following categories: a) patients who complete the test in ≤12 seconds, and b) those who require >12 seconds to complete the test or were unable to complete the test. We selected 12 seconds as the cut-off because this was the threshold used by the Centers for Disease Control and Prevention. We report the number of participants in each group who required >12 seconds to complete the test or were unable to complete the test
Measured: Measured 2 years after original surgery
Health-Related Quality of Life (SF-12)
Health-related quality of life measured using the SF-12 Health Survey, which is a standardized instrument to measure health- related quality of life. This self-administered, 12-item questionnaire covers eight main health domains that make up the Physical and Mental Health Composite Scores (PCS \& MCS). Each domain consists of one or two questions and is scored separately from 0 (lowest level) to 100 (highest level). Higher scores represent better health-related quality of life.
Measured: Measured 2 years after original surgery
Health-Related Quality of Life (EQ-5D)
Health-related quality of life was measured using the EQ-5D, which is a standardized instrument that comprises of a short descriptive system questionnaire and a visual analogue scale (EQ-5D VAS).
The questionnaire provides a simple descriptive profile of a respondent's health state. When the descriptive system profile is linked to a 'value set', a single summary index value for health status on a 0 to 1 scale is derived that can be used in economic evaluations of healthcare interventions. A health utility value of 1 indicates perfect health while a score of 0 indicates death.
The EQ-5D VAS assesses the individual's health today on a scale from 0-100, with the 0 being 'worst imaginable state of health' and 100 being 'best imaginable state of health'.
Measured: Measured 2 years after original surgery
Complications, Including Mortality, Dislocation, Infection, Femoral Fracture, Deep Venous Thrombosis, and Prosthesis Loosening
Hip-related complications including peri-prosthetic fracture, hip instability or dislocation, implant failure (loosening/subsidence and breakage), would healing problems (including superficial/deep infection, wound necrosis), soft tissue problems (e.g. pseudotumor), heterotopic ossification, abductor failure, implant wear and corrosion, osteolysis, neurovascular injury, decreased function, or pain. Measured at 1 and 10 weeks, 6, 9,12, 18, 24 months.
Measured: Measured 2 years after original surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startMar 2009
- Primary completion30 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,495 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Hamilton Health Sciences Corporation, ZonMw: The Netherlands Organisation for Health Research and Development, Sophies Minde Ortopedi
- Responsible party
- Sponsor
- Investigators
- Mohit Bhandari, MD PhD FRCSC, Principal investigator, McMaster UniversityThomas A. Eihnorn, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556842
- Sponsor's protocol ID
- UM1AR063386-01
- Other IDs
- UM1AR063386, 1R01AR055130-01A1, MOP 126188
- Acronym
- HEALTH
- Status last verified
- Nov 2019
- First submitted
- 9 Nov 2007
- Last updated
- 7 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 22999009Burgers 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.
PubMed 22623062Burgers 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.
PubMed 26821137Bhandari 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.
PubMed 25681312Burgers 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.
PubMed 25948522HEALTH 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.
PubMed 31557429
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hip Fracture Evaluation With Alternatives of Total Hip Arthroplasty Versus Hemi-Arthroplasty: A Multi-Centre Randomized Trial Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Secondary Procedures and Quality of Life in Patients With Displaced Femoral Neck Fractures
- ClinicalTrials.gov ID
- NCT00556842
- Acronym / sponsor ID
- HEALTH / UM1AR063386-01
- Conditions
- Hip Fractures, Femoral Neck Fractures
- Keywords
- Hemi-Arthroplasty, Total Hip Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,495 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Hamilton Health Sciences Corporation, ZonMw: The Netherlands Organisation for Health Research and Development, Sophies Minde Ortopedi
- Study start
- Mar 2009
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 12 Nov 2007 (estimated)
- Results
- Posted 7 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Total hip arthroplastyParticipants will undergo total hip arthroplasty. |
| 2 | Active comparator | Device: Hemi-arthroplastyParticipants will undergo hemi-arthroplasty. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total hip arthroplastyAlso: THAProscribed 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. | Device | 1 |
| Hemi-arthroplastyAlso: HASurgeons 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. | Device | 2 |
Primary outcome
Number of Participants With Revision Surgery
Time frame: Measured 2 years after original surgery
The primary outcome is any unplanned secondary procedure within 2 years of the initial joint replacement surgery.
5 secondary outcomes
Hip Function and Pain
Time frame: Measured 2 years after original surgery
Number of Participants With Functional Mobility Problems
Time frame: Measured 2 years after original surgery
Health-Related Quality of Life (SF-12)
Time frame: Measured 2 years after original surgery
Health-Related Quality of Life (EQ-5D)
Time frame: Measured 2 years after original surgery
Complications, Including Mortality, Dislocation, Infection, Femoral Fracture, Deep Venous Thrombosis, and Prosthesis Loosening
Time frame: Measured 2 years after original surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22999009Hebert-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.
- Background: PubMed 22623062Burgers 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.
- Background: PubMed 26821137Burgers 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.
- Background: PubMed 25681312Bhandari 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.
- Background: PubMed 25948522Burgers 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.
- Derived from this study: PubMed 31557429HEALTH 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohit Bhandari, MD PhD FRCSC principal investigator
McMaster University
Thomas A. Eihnorn, MD principal investigator
Boston University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total hip arthroplasty and Hemi-arthroplasty in people with Hip Fractures and Femoral Neck Fractures, run by McMaster University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Revision Surgery (time frame: Measured 2 years after original surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00556842, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.