Trial Outcomes & Findings for Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Secondary Procedures and Quality of Life in Adults With Displaced Hip Fractures (NCT NCT00556842)

NCT ID: NCT00556842

Last Updated: 2020-07-07

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1495 participants
• Primary outcome timeframe: Measured 2 years after original surgery
• Results posted on: 2020-07-07

Participant Flow

Participant milestones

Measure	Total Hip Arthroplasty 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.	Hemi-arthroplasty 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 Study STARTED	749	746
Overall Study COMPLETED	718	723
Overall Study NOT COMPLETED	31	23

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Total Hip Arthroplasty n=718 Participants 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.	Hemi-Arthroplasty n=723 Participants 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 n=1441 Participants Total of all reporting groups
Age, Continuous	79.1 years STANDARD_DEVIATION 8.3 • n=5 Participants	78.6 years STANDARD_DEVIATION 8.6 • n=7 Participants	78.8 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	510 Participants n=5 Participants	499 Participants n=7 Participants	1009 Participants n=5 Participants
Sex: Female, Male Male	208 Participants n=5 Participants	224 Participants n=7 Participants	432 Participants n=5 Participants
Race/Ethnicity, Customized Native or Aboriginal	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized South Asian	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized East Asian	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized White	683 Participants n=5 Participants	684 Participants n=7 Participants	1367 Participants n=5 Participants
Race/Ethnicity, Customized Black	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized Middle Eastern	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Prefracture Living Status Institutionalized	30 Participants n=5 Participants	27 Participants n=7 Participants	57 Participants n=5 Participants
Prefracture Living Status Not institutionalized	688 Participants n=5 Participants	696 Participants n=7 Participants	1384 Participants n=5 Participants
Prefracture Functional Status Uses assistive device for ambulation	187 Participants n=5 Participants	182 Participants n=7 Participants	369 Participants n=5 Participants
Prefracture Functional Status Able to ambulate without assistive device	531 Participants n=5 Participants	541 Participants n=7 Participants	1072 Participants n=5 Participants
Previous Surgery to Affected Hip	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Major Coexisting Conditions Osteopenia	28 participants n=5 Participants	30 participants n=7 Participants	58 participants n=5 Participants
Major Coexisting Conditions Osteoporosis	114 participants n=5 Participants	110 participants n=7 Participants	224 participants n=5 Participants
Major Coexisting Conditions Lung disease	127 participants n=5 Participants	122 participants n=7 Participants	249 participants n=5 Participants
Major Coexisting Conditions Diabetes	135 participants n=5 Participants	145 participants n=7 Participants	280 participants n=5 Participants
Major Coexisting Conditions Ulcers or stomach disease	49 participants n=5 Participants	67 participants n=7 Participants	116 participants n=5 Participants
Major Coexisting Conditions Kidney disease	71 participants n=5 Participants	67 participants n=7 Participants	138 participants n=5 Participants
Major Coexisting Conditions Anemia or other blood disease	48 participants n=5 Participants	55 participants n=7 Participants	103 participants n=5 Participants
Major Coexisting Conditions Depression	70 participants n=5 Participants	84 participants n=7 Participants	154 participants n=5 Participants
Major Coexisting Conditions Cancer	65 participants n=5 Participants	80 participants n=7 Participants	145 participants n=5 Participants
Major Coexisting Conditions Osteoarthritis, degenerative arthritis	111 participants n=5 Participants	91 participants n=7 Participants	202 participants n=5 Participants
Major Coexisting Conditions Back pain	64 participants n=5 Participants	71 participants n=7 Participants	135 participants n=5 Participants
Major Coexisting Conditions Rheumatoid arthritis	13 participants n=5 Participants	21 participants n=7 Participants	34 participants n=5 Participants
Major Coexisting Conditions Heart disease	247 participants n=5 Participants	249 participants n=7 Participants	496 participants n=5 Participants
Major Coexisting Conditions High blood pressure	434 participants n=5 Participants	443 participants n=7 Participants	877 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured 2 years after original surgery

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

Outcome measures

Measure	Total Hip Arthroplasty n=718 Participants 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.	Hemi-arthroplasty n=723 Participants 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.
Number of Participants With Revision Surgery	57 Participants	60 Participants

SECONDARY outcome

Timeframe: Measured 2 years after original surgery

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.

Outcome measures

Measure	Total Hip Arthroplasty n=718 Participants 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.	Hemi-arthroplasty n=723 Participants 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.
Hip Function and Pain WOMAC total score	14.29 units on a scale Standard Deviation 15.64	17.22 units on a scale Standard Deviation 16.99
Hip Function and Pain WOMAC pain score	1.65 units on a scale Standard Deviation 2.97	2.21 units on a scale Standard Deviation 3.35
Hip Function and Pain WOMAC stiffness score	1.05 units on a scale Standard Deviation 1.44	1.22 units on a scale Standard Deviation 1.63
Hip Function and Pain WOMAC function score	11.13 units on a scale Standard Deviation 12.34	13.09 units on a scale Standard Deviation 13.00

SECONDARY outcome

Timeframe: Measured 2 years after original surgery

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

Outcome measures

Measure	Total Hip Arthroplasty n=718 Participants 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.	Hemi-arthroplasty n=723 Participants 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.
Number of Participants With Functional Mobility Problems	210 Participants	206 Participants

SECONDARY outcome

Timeframe: Measured 2 years after original surgery

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.

Outcome measures

Measure	Total Hip Arthroplasty n=718 Participants 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.	Hemi-arthroplasty n=723 Participants 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.
Health-Related Quality of Life (SF-12) SF-12 MCS	54.03 units on a scale Standard Deviation 9.77	51.36 units on a scale Standard Deviation 11.83
Health-Related Quality of Life (SF-12) SF-12 PCS	41.89 units on a scale Standard Deviation 11.25	41.27 units on a scale Standard Deviation 11.34

SECONDARY outcome

Timeframe: Measured 2 years after original surgery

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'.

Outcome measures

Measure	Total Hip Arthroplasty n=718 Participants 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.	Hemi-arthroplasty n=723 Participants 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.
Health-Related Quality of Life (EQ-5D) EQ-5D utility index score	0.82 units on a scale Standard Deviation 0.19	0.77 units on a scale Standard Deviation 0.22
Health-Related Quality of Life (EQ-5D) EQ-5D VAS score	72.26 units on a scale Standard Deviation 18.76	70.84 units on a scale Standard Deviation 19.44

SECONDARY outcome

Timeframe: Measured 2 years after original surgery

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.

Outcome measures

Measure	Total Hip Arthroplasty n=718 Participants 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.	Hemi-arthroplasty n=723 Participants 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.
Complications, Including Mortality, Dislocation, Infection, Femoral Fracture, Deep Venous Thrombosis, and Prosthesis Loosening Death	103 participants	95 participants
Complications, Including Mortality, Dislocation, Infection, Femoral Fracture, Deep Venous Thrombosis, and Prosthesis Loosening Serious adverse event	300 participants	265 participants
Complications, Including Mortality, Dislocation, Infection, Femoral Fracture, Deep Venous Thrombosis, and Prosthesis Loosening Any hip-related complication	132 participants	118 participants

Adverse Events

Total Hip Arthroplasty

Serious events: 300 serious events

Other events: 132 other events

Deaths: 103 deaths

Hemi-arthroplasty

Serious events: 265 serious events

Other events: 118 other events

Deaths: 95 deaths

Serious adverse events

Measure	Total Hip Arthroplasty n=718 participants at risk 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.	Hemi-arthroplasty n=723 participants at risk 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.
Musculoskeletal and connective tissue disorders Hip fracture-related serious adverse event	8.2% 59/718 • Adverse event data was collected throughout the 24 month follow-up period.	7.9% 57/723 • Adverse event data was collected throughout the 24 month follow-up period.
Nervous system disorders Neurologic serious adverse event	3.9% 28/718 • Adverse event data was collected throughout the 24 month follow-up period.	3.6% 26/723 • Adverse event data was collected throughout the 24 month follow-up period.
Respiratory, thoracic and mediastinal disorders Respiratory serious adverse event	5.8% 42/718 • Adverse event data was collected throughout the 24 month follow-up period.	5.1% 37/723 • Adverse event data was collected throughout the 24 month follow-up period.
Cardiac disorders Cardiac serious adverse event	7.1% 51/718 • Adverse event data was collected throughout the 24 month follow-up period.	6.8% 49/723 • Adverse event data was collected throughout the 24 month follow-up period.
Renal and urinary disorders Renal serious adverse event	3.2% 23/718 • Adverse event data was collected throughout the 24 month follow-up period.	3.0% 22/723 • Adverse event data was collected throughout the 24 month follow-up period.
Vascular disorders Vascular serious adverse event	3.1% 22/718 • Adverse event data was collected throughout the 24 month follow-up period.	2.2% 16/723 • Adverse event data was collected throughout the 24 month follow-up period.
Musculoskeletal and connective tissue disorders Other serious adverse event	28.0% 201/718 • Adverse event data was collected throughout the 24 month follow-up period.	24.5% 177/723 • Adverse event data was collected throughout the 24 month follow-up period.

Other adverse events

Measure	Total Hip Arthroplasty n=718 participants at risk 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.	Hemi-arthroplasty n=723 participants at risk 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.
Musculoskeletal and connective tissue disorders Periprosthetic fracture	5.3% 38/718 • Adverse event data was collected throughout the 24 month follow-up period.	4.8% 35/723 • Adverse event data was collected throughout the 24 month follow-up period.
Musculoskeletal and connective tissue disorders Hip instability or dislocation	4.7% 34/718 • Adverse event data was collected throughout the 24 month follow-up period.	2.4% 17/723 • Adverse event data was collected throughout the 24 month follow-up period.
Musculoskeletal and connective tissue disorders Superficial surgical-site infection	1.3% 9/718 • Adverse event data was collected throughout the 24 month follow-up period.	0.83% 6/723 • Adverse event data was collected throughout the 24 month follow-up period.
Musculoskeletal and connective tissue disorders Deep surgical-site infection	2.4% 17/718 • Adverse event data was collected throughout the 24 month follow-up period.	2.2% 16/723 • Adverse event data was collected throughout the 24 month follow-up period.
Musculoskeletal and connective tissue disorders Another wound-healing problem	0.84% 6/718 • Adverse event data was collected throughout the 24 month follow-up period.	0.69% 5/723 • Adverse event data was collected throughout the 24 month follow-up period.
Musculoskeletal and connective tissue disorders Another soft-tissue procedure	1.5% 11/718 • Adverse event data was collected throughout the 24 month follow-up period.	1.5% 11/723 • Adverse event data was collected throughout the 24 month follow-up period.
Musculoskeletal and connective tissue disorders Clinically important heterotopic ossification	4.0% 29/718 • Adverse event data was collected throughout the 24 month follow-up period.	3.3% 24/723 • Adverse event data was collected throughout the 24 month follow-up period.
Musculoskeletal and connective tissue disorders Abductor failure	0.14% 1/718 • Adverse event data was collected throughout the 24 month follow-up period.	0.41% 3/723 • Adverse event data was collected throughout the 24 month follow-up period.
Musculoskeletal and connective tissue disorders Implant failure: loosening or subsidence	0.70% 5/718 • Adverse event data was collected throughout the 24 month follow-up period.	0.69% 5/723 • Adverse event data was collected throughout the 24 month follow-up period.
Musculoskeletal and connective tissue disorders Implant failure: breakage	0.14% 1/718 • Adverse event data was collected throughout the 24 month follow-up period.	0.00% 0/723 • Adverse event data was collected throughout the 24 month follow-up period.
Musculoskeletal and connective tissue disorders Pain	0.84% 6/718 • Adverse event data was collected throughout the 24 month follow-up period.	1.7% 12/723 • Adverse event data was collected throughout the 24 month follow-up period.
Musculoskeletal and connective tissue disorders Neurovascular injury: technical error	0.28% 2/718 • Adverse event data was collected throughout the 24 month follow-up period.	0.14% 1/723 • Adverse event data was collected throughout the 24 month follow-up period.
Musculoskeletal and connective tissue disorders Other	0.97% 7/718 • Adverse event data was collected throughout the 24 month follow-up period.	1.8% 13/723 • Adverse event data was collected throughout the 24 month follow-up period.

Additional Information

Paula McKay

The Centre for Evidence-Based Orthopaedics

Phone: 905-521-2100

Email: mckayp@mcmaster.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place