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Trial record 1 of 1 for:    Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Secondary Procedures and Quality of Life in Adults with Displaced Hip Fractures
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Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Secondary Procedures and Quality of Life in Adults With Displaced Hip Fractures (HEALTH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00556842
Recruitment Status : Completed
First Posted : November 12, 2007
Results First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
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 AS
Information provided by (Responsible Party):
McMaster University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hip Fractures
Femoral Neck Fractures
Interventions Device: Total hip arthroplasty
Device: Hemi-arthroplasty
Enrollment 1495
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Total Hip Arthroplasty Hemi-arthroplasty
Hide Arm/Group Description

Participants will undergo total hip arthroplasty.

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.

Participants will undergo hemi-arthroplasty.

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.

Period Title: Overall Study
Started 749 746
Completed 718 723
Not Completed 31 23
Arm/Group Title Total Hip Arthroplasty Hemi-Arthroplasty Total
Hide Arm/Group Description

Participants will undergo total hip arthroplasty.

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.

Participants will undergo hemi-arthroplasty.

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.

Total of all reporting groups
Overall Number of Baseline Participants 718 723 1441
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 718 participants 723 participants 1441 participants
79.1  (8.3) 78.6  (8.6) 78.8  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 718 participants 723 participants 1441 participants
Female
510
  71.0%
499
  69.0%
1009
  70.0%
Male
208
  29.0%
224
  31.0%
432
  30.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 718 participants 723 participants 1441 participants
Native or Aboriginal
2
   0.3%
1
   0.1%
3
   0.2%
South Asian
3
   0.4%
6
   0.8%
9
   0.6%
East Asian
7
   1.0%
7
   1.0%
14
   1.0%
Hispanic or Latino
7
   1.0%
6
   0.8%
13
   0.9%
White
683
  95.1%
684
  94.6%
1367
  94.9%
Black
12
   1.7%
15
   2.1%
27
   1.9%
Middle Eastern
1
   0.1%
1
   0.1%
2
   0.1%
Prefracture Living Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 718 participants 723 participants 1441 participants
Institutionalized
30
   4.2%
27
   3.7%
57
   4.0%
Not institutionalized
688
  95.8%
696
  96.3%
1384
  96.0%
Prefracture Functional Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 718 participants 723 participants 1441 participants
Uses assistive device for ambulation
187
  26.0%
182
  25.2%
369
  25.6%
Able to ambulate without assistive device
531
  74.0%
541
  74.8%
1072
  74.4%
Previous Surgery to Affected Hip  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 718 participants 723 participants 1441 participants
2
   0.3%
1
   0.1%
3
   0.2%
Major Coexisting Conditions  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 718 participants 723 participants 1441 participants
Osteopenia 28 30 58
Osteoporosis 114 110 224
Lung disease 127 122 249
Diabetes 135 145 280
Ulcers or stomach disease 49 67 116
Kidney disease 71 67 138
Anemia or other blood disease 48 55 103
Depression 70 84 154
Cancer 65 80 145
Osteoarthritis, degenerative arthritis 111 91 202
Back pain 64 71 135
Rheumatoid arthritis 13 21 34
Heart disease 247 249 496
High blood pressure 434 443 877
1.Primary Outcome
Title Number of Participants With Revision Surgery
Hide Description The primary outcome is any unplanned secondary procedure within 2 years of the initial joint replacement surgery.
Time Frame Measured 2 years after original surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Hip Arthroplasty Hemi-arthroplasty
Hide Arm/Group Description:

Participants will undergo total hip arthroplasty.

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.

Participants will undergo hemi-arthroplasty.

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.

Overall Number of Participants Analyzed 718 723
Measure Type: Count of Participants
Unit of Measure: Participants
57
   7.9%
60
   8.3%
2.Secondary Outcome
Title Hip Function and Pain
Hide Description 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.
Time Frame Measured 2 years after original surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Hip Arthroplasty Hemiarthroplasty
Hide Arm/Group Description:
WOMAC scores for the THA group at 24 months.
WOMAC scores for the HA group at 24 months.
Overall Number of Participants Analyzed 718 723
Mean (Standard Deviation)
Unit of Measure: units on a scale
WOMAC total score 14.29  (15.64) 17.22  (16.99)
WOMAC pain score 1.65  (2.97) 2.21  (3.35)
WOMAC stiffness score 1.05  (1.44) 1.22  (1.63)
WOMAC function score 11.13  (12.34) 13.09  (13.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Hip Arthroplasty, Hemiarthroplasty
Comments Using a multi-level model, the effect of THA versus HA on function (WOMAC) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for WOMAC total at 24 months.
Type of Statistical Test Equivalence
Comments Please refer to the protocol paper for details of the power calculation.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.37
Confidence Interval (2-Sided) 99%
-9.18 to -3.56
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Total Hip Arthroplasty, Hemiarthroplasty
Comments Using a multi-level model, the effect of THA versus HA on function (WOMAC) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for WOMAC pain at 24 months.
Type of Statistical Test Equivalence
Comments Please refer to the protocol paper for details of the power calculation.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.93
Confidence Interval (2-Sided) 99%
-1.42 to -0.44
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Total Hip Arthroplasty, Hemiarthroplasty
Comments Using a multi-level model, the effect of THA versus HA on function (WOMAC) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for WOMAC stiffness at 24 months.
Type of Statistical Test Equivalence
Comments Please refer to the protocol paper for details of the power calculation.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.44
Confidence Interval (2-Sided) 99%
-0.65 to -0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Total Hip Arthroplasty, Hemiarthroplasty
Comments Using a multi-level model, the effect of THA versus HA on function (WOMAC) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for WOMAC function at 24 months.
Type of Statistical Test Equivalence
Comments Please refer to the protocol paper for details of the power calculation.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.97
Confidence Interval (2-Sided) 99%
-7.11 to -2.83
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Functional Mobility Problems
Hide Description

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

Time Frame Measured 2 years after original surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Hip Arthroplasty Hemiarthroplasty
Hide Arm/Group Description:
THA Participants who took more than 12 seconds to complete the TUG test or were unable to complete the test.
HA Participants who took more than 12 seconds to complete the TUG test or were unable to complete the test.
Overall Number of Participants Analyzed 718 723
Measure Type: Count of Participants
Unit of Measure: Participants
210
  29.2%
206
  28.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Hip Arthroplasty, Hemiarthroplasty
Comments Using a multi-level model, the effect of THA versus HA on mobility (TUG) was estimated. 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. The TUG was summarized using odds ratios and 99% CIs.
Type of Statistical Test Equivalence
Comments Please refer to the protocol paper for details of the power calculation.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.72
Confidence Interval (2-Sided) 99%
0.38 to 1.36
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Health-Related Quality of Life (SF-12)
Hide Description 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.
Time Frame Measured 2 years after original surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Hip Arthroplasty Hemiarthroplasty
Hide Arm/Group Description:
SF-12 scores for the THA group at 24 months.
SF-12 scores for the HA group at 24 months.
Overall Number of Participants Analyzed 718 723
Mean (Standard Deviation)
Unit of Measure: units on a scale
SF-12 PCS 41.89  (11.25) 41.27  (11.34)
SF-12 MCS 54.03  (9.77) 51.36  (11.83)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Hip Arthroplasty, Hemiarthroplasty
Comments Using a multi-level model, the effect of THA versus HA on quality of life (SF-12) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for SF-12 PCS at 24 months.
Type of Statistical Test Equivalence
Comments Please refer to the protocol paper for details of the power calculation.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.41
Confidence Interval (2-Sided) 99%
-0.33 to 3.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Total Hip Arthroplasty, Hemiarthroplasty
Comments Using a multi-level model, the effect of THA versus HA on quality of life (SF-12) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for SF-12 MCS at 24 months.
Type of Statistical Test Equivalence
Comments Please refer to the protocol paper for details of the power calculation.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.34
Confidence Interval (2-Sided) 99%
-0.38 to 3.05
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Health-Related Quality of Life (EQ-5D)
Hide Description

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'.

Time Frame Measured 2 years after original surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Hip Arthroplasty Hemiarthroplasty
Hide Arm/Group Description:
EQ-5D scores for the THA group at 24 months.
EQ-5D scores for the HA group at 24 months.
Overall Number of Participants Analyzed 718 723
Mean (Standard Deviation)
Unit of Measure: units on a scale
EQ-5D utility index score 0.82  (0.19) 0.77  (0.22)
EQ-5D VAS score 72.26  (18.76) 70.84  (19.44)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Hip Arthroplasty, Hemiarthroplasty
Comments Using a multi-level model, the effect of THA versus HA on quality of life (EQ-5D) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for EQ-5D utility index at 24 months.
Type of Statistical Test Equivalence
Comments Please refer to the protocol paper for details of the power calculation.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.04
Confidence Interval (2-Sided) 99%
-0.03 to 0.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Total Hip Arthroplasty, Hemiarthroplasty
Comments Using a multi-level model, the effect of THA versus HA on quality of life (EQ-5D) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for EQ-5D VAS at 24 months.
Type of Statistical Test Equivalence
Comments Please refer to the protocol paper for details of the power calculation.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.72
Confidence Interval (2-Sided) 99%
-2.02 to 3.46
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Complications, Including Mortality, Dislocation, Infection, Femoral Fracture, Deep Venous Thrombosis, and Prosthesis Loosening
Hide Description 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.
Time Frame Measured 2 years after original surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Hip Arthroplasty Hemi-arthroplasty
Hide Arm/Group Description:

Participants will undergo total hip arthroplasty.

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.

Participants will undergo hemi-arthroplasty.

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.

Overall Number of Participants Analyzed 718 723
Measure Type: Number
Unit of Measure: participants
Death 103 95
Serious adverse event 300 265
Any hip-related complication 132 118
Time Frame Adverse event data was collected throughout the 24 month follow-up period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Total Hip Arthroplasty Hemi-arthroplasty
Hide Arm/Group Description

Participants will undergo total hip arthroplasty.

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.

Participants will undergo hemi-arthroplasty.

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.

All-Cause Mortality
Total Hip Arthroplasty Hemi-arthroplasty
Affected / at Risk (%) Affected / at Risk (%)
Total   103/718 (14.35%)   95/723 (13.14%) 
Hide Serious Adverse Events
Total Hip Arthroplasty Hemi-arthroplasty
Affected / at Risk (%) Affected / at Risk (%)
Total   300/718 (41.78%)   265/723 (36.65%) 
Cardiac disorders     
Cardiac serious adverse event   51/718 (7.10%)  49/723 (6.78%) 
Musculoskeletal and connective tissue disorders     
Hip fracture-related serious adverse event   59/718 (8.22%)  57/723 (7.88%) 
Other serious adverse event  [1]  201/718 (27.99%)  177/723 (24.48%) 
Nervous system disorders     
Neurologic serious adverse event   28/718 (3.90%)  26/723 (3.60%) 
Renal and urinary disorders     
Renal serious adverse event   23/718 (3.20%)  22/723 (3.04%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory serious adverse event   42/718 (5.85%)  37/723 (5.12%) 
Vascular disorders     
Vascular serious adverse event   22/718 (3.06%)  16/723 (2.21%) 
Indicates events were collected by systematic assessment
[1]
including: non-trial related fracture, non-trial related dislocation, other non-trial related injury, cellulitis, death, multiorgan failure, osteoporosis, sepsis, reported by site as "other"
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Total Hip Arthroplasty Hemi-arthroplasty
Affected / at Risk (%) Affected / at Risk (%)
Total   132/718 (18.38%)   118/723 (16.32%) 
Musculoskeletal and connective tissue disorders     
Periprosthetic fracture   38/718 (5.29%)  35/723 (4.84%) 
Hip instability or dislocation   34/718 (4.74%)  17/723 (2.35%) 
Superficial surgical-site infection   9/718 (1.25%)  6/723 (0.83%) 
Deep surgical-site infection   17/718 (2.37%)  16/723 (2.21%) 
Another wound-healing problem   6/718 (0.84%)  5/723 (0.69%) 
Another soft-tissue procedure   11/718 (1.53%)  11/723 (1.52%) 
Clinically important heterotopic ossification   29/718 (4.04%)  24/723 (3.32%) 
Abductor failure   1/718 (0.14%)  3/723 (0.41%) 
Implant failure: loosening or subsidence   5/718 (0.70%)  5/723 (0.69%) 
Implant failure: breakage   1/718 (0.14%)  0/723 (0.00%) 
Pain   6/718 (0.84%)  12/723 (1.66%) 
Neurovascular injury: technical error   2/718 (0.28%)  1/723 (0.14%) 
Other   7/718 (0.97%)  13/723 (1.80%) 
Indicates events were collected by systematic assessment
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Paula McKay
Organization: The Centre for Evidence-Based Orthopaedics
Phone: 905-521-2100 ext 44131
EMail: mckayp@mcmaster.ca
Publications:
Layout table for additonal information
Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT00556842    
Other Study ID Numbers: UM1AR063386-01 ( U.S. NIH Grant/Contract )
UM1AR063386 ( U.S. NIH Grant/Contract )
1R01AR055130-01A1 ( U.S. NIH Grant/Contract )
MOP 126188 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
First Submitted: November 9, 2007
First Posted: November 12, 2007
Results First Submitted: November 25, 2019
Results First Posted: July 7, 2020
Last Update Posted: July 7, 2020