Total Hip ReplacementPhase 4NCT01522014
Randomized Clinical Trial of Ceramic Bearing Primary Total Hip Arthroplasty
A Phase 4 study testing Secure-Fit™ arc-deposited Hydroxylapatite (HA) shell - surface ceramic and an Alumina Bearing Couple (ABC) ceramic insert and Ceramic C-taper head and Secure-Fit™ arc-deposited hydroxylapatite shell, a Crossfire® insert and a Ceramic C-taper head in people with Total Hip Replacement, run by University of Alberta at 2 sites in Canada.
Trial summary
Primary total hip arthroplasty (THA) has been a very successful surgical intervention in the geriatric population. Numerous studies have reported good mid and long term results of THA in patients over the age of 60 years. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Total Hip Replacement
- What is being tested?
- Secure-Fit™ arc-deposited Hydroxylapatite (HA) shell - surface ceramic and an Alumina Bearing Couple (ABC) ceramic insert and Ceramic C-taper head and Secure-Fit™ arc-deposited hydroxylapatite shell, a Crossfire® insert and a Ceramic C-taper head
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 1997to Jun 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males or females scheduled for primary THA to treat non-inflammatory arthritis
- Less than 61 years old at time of surgery
- Able to speak and read the English language or have an available translator
- Dorr Index A or B bone quality on preoperative radiographs
- Willing and able to return for follow-up visits
Who cannot join
- Have femoral or acetabular bone deficiency requiring augmentation
- Ongoing corticosteroid use
- Dorr Index C bone quality on the preoperative radiograph
- Required a prosthesis neck length of greater than five millimeters
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Royal Alexandra Hospital
Edmonton, Alberta
About this study
Official title: Five-Year Outcome of Ceramic on Ceramic Bearing Versus Ceramic on Crossfire® Highly Cross-Linked Polyethylene Bearing in Primary Total Hip Arthroplasty: A Randomized Trial
Primary total hip arthroplasty (THA) has been a very successful surgical intervention in the geriatric population. Numerous studies have reported good mid and long term results of THA in patients over the age of 60 years. With the reported high success rate of this surgical intervention, the THA surgery is being performed in younger patients who have significant joint disease.
A clinical trial, using a randomized blinded design, was undertaken to compare the functional outcome of 1) alumina heads/alumina liners, and 2) alumina head/Crossfire polyethylene liners in patients 60 years of age or younger with non-inflammatory arthritis of the hip.
Read more
Subjects were assessed preoperatively and at one and five years postoperatively. Ten-year follow-up is currently underway.
The primary outcome measure is the WOMAC Osteoarthritis Index. Secondary measures were the RAND-12, as well as measurement of complication and revision rates. The patient's demand on the implant as calculated by the patient's age, weight, health status and activity level was also measured.
- Conditions
- Total Hip Replacement
- Being tested
- Secure-Fit™ arc-deposited Hydroxylapatite (HA) shell - surface ceramic and an Alumina Bearing Couple (ABC) ceramic insert and Ceramic C-taper head, Secure-Fit™ arc-deposited hydroxylapatite shell, a Crossfire® insert and a Ceramic C-taper head
- Keywords
- Joint Replacement, Health Related Quality of Life, Functional Outcomes, Revision Rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secure-Fit™ arc-deposited Hydroxylapatite (HA) shell - surface ceramic and an Alumina Bearing Couple (ABC) ceramic insert and Ceramic C-taper headDevice
Secure-Fit™ arc-deposited hydroxylapatite shell, a Crossfire® insert and a Ceramic C-taper headDevice
| Study group | Role | What they receive |
|---|---|---|
| Ceramic on Ceramic | Active comparator | Subjects received a ceramic on ceramic bearing total hip replacement. Receives: Device: Secure-Fit™ arc-deposited Hydroxylapatite (HA) shell - surface ceramic and an Alumina Bearing Couple (ABC) ceramic insert and Ceramic C-taper head |
| Ceramic-on-Highly Crosslinked Polyethylene | Active comparator | Not described Receives: Device: Secure-Fit™ arc-deposited hydroxylapatite shell, a Crossfire® insert and a Ceramic C-taper head |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario McMaster Osteoarthritis Index (WOMAC) Pain Score
This is a disease-specific, patient reported outcome measure of pain.
Measured: Five Years
WOMAC Function Score
This is a disease-specific patient reported outcome measure of function
Measured: Five years
WOMAC Stiffness Score
This is a disease-specific, patient-reported outcome measure of stiffness.
Measured: Five Years
Secondary outcomes (13)
WOMAC Pain Score
This is a disease-specific, patient-reported outcome measure of pain.
Measured: One Year
WOMAC Function Score
This is a disease-specific, patient-reported outcome measure of function.
Measured: One Year
WOMAC Stiffness Score
This is a disease-specific, patient-reported outcome measure of stiffness.
Measured: One Year
RAND 12-Item Health Survey (RAND-12)
This is a generic patient-reported outcome measure of health status.
Measured: Five Years
RAND-12
This is a generic patient-reported outcome measure of health status.
Measured: One years
Complications
This measured the postoperative complications.
Measured: Five Years
Revisions
This measured the number of revisions in five years
Measured: Five Years
WOMAC Pain Score
Measured: 10 Years
WOMAC Function Scores
Measured: 10 years
WOMAC Stiffness Score
Measured: 10 years
RAND-12
Measured: 10 years
Complications
Measured: 10 years
Revision Rate
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startNov 1997
- Primary completionJan 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ReplacementStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Canada LP
- Responsible party
- Sponsor
- Investigators
- Lauren Beaupre, PT, PhD, Study director, University of AlbertaD William C Johnston, MD, FRCS (C), Principal investigator, Alberta Health services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522014
- Sponsor's protocol ID
- Pro00000886
- Status last verified
- Jul 2021
- First submitted
- 26 Jan 2012
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Five-Year Outcome of Ceramic on Ceramic Bearing Versus Ceramic on Crossfire® Highly Cross-Linked Polyethylene Bearing in Primary Total Hip Arthroplasty: A Randomized Trial
- ClinicalTrials.gov ID
- NCT01522014
- Acronym / sponsor ID
- Pro00000886
- Conditions
- Total Hip Replacement
- Keywords
- Joint Replacement, Health Related Quality of Life, Functional Outcomes, Revision Rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Stryker Canada LP
- Study start
- Nov 1997
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 31 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary total hip arthroplasty (THA) has been a very successful surgical intervention in the geriatric population. Numerous studies have reported good mid and long term results of THA in patients over the age of 60 years. With the reported high success rate of this surgical intervention, the THA surgery is being performed in younger patients who have significant joint disease.
A clinical trial, using a randomized blinded design, was undertaken to compare the functional outcome of 1) alumina heads/alumina liners, and 2) alumina head/Crossfire polyethylene liners in patients 60 years of age or younger with non-inflammatory arthritis of the hip.
Subjects were assessed preoperatively and at one and five years postoperatively. Ten-year follow-up is currently underway.
The primary outcome measure is the WOMAC Osteoarthritis Index. Secondary measures were the RAND-12, as well as measurement of complication and revision rates. The patient's demand on the implant as calculated by the patient's age, weight, health status and activity level was also measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ceramic on Ceramic | Active comparator | Device: Secure-Fit™ arc-deposited Hydroxylapatite (HA) shell - surface ceramic and an Alumina Bearing Couple (ABC) ceramic insert and Ceramic C-taper headSubjects received a ceramic on ceramic bearing total hip replacement. |
| Ceramic-on-Highly Crosslinked Polyethylene | Active comparator | Device: Secure-Fit™ arc-deposited hydroxylapatite shell, a Crossfire® insert and a Ceramic C-taper head |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males or females scheduled for primary THA to treat non-inflammatory arthritis
- Less than 61 years old at time of surgery
- Able to speak and read the English language or have an available translator
- Dorr Index A or B bone quality on preoperative radiographs
- Willing and able to return for follow-up visits
Key exclusion criteria (4 listed)
- Have femoral or acetabular bone deficiency requiring augmentation
- Ongoing corticosteroid use
- Dorr Index C bone quality on the preoperative radiograph
- Required a prosthesis neck length of greater than five millimeters
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 |
|---|---|---|
| Secure-Fit™ arc-deposited Hydroxylapatite (HA) shell - surface ceramic and an Alumina Bearing Couple (ABC) ceramic insert and Ceramic C-taper head | Device | Ceramic on Ceramic |
| Secure-Fit™ arc-deposited hydroxylapatite shell, a Crossfire® insert and a Ceramic C-taper head | Device | Ceramic-on-Highly Crosslinked Polyethylene |
Primary outcome
Western Ontario McMaster Osteoarthritis Index (WOMAC) Pain Score
Time frame: Five Years
This is a disease-specific, patient reported outcome measure of pain.
WOMAC Function Score
Time frame: Five years
This is a disease-specific patient reported outcome measure of function
WOMAC Stiffness Score
Time frame: Five Years
This is a disease-specific, patient-reported outcome measure of stiffness.
13 secondary outcomes
WOMAC Pain Score
Time frame: One Year
WOMAC Function Score
Time frame: One Year
WOMAC Stiffness Score
Time frame: One Year
RAND 12-Item Health Survey (RAND-12)
Time frame: Five Years
RAND-12
Time frame: One years
Complications
Time frame: Five Years
Revisions
Time frame: Five Years
WOMAC Pain Score
Time frame: 10 Years
WOMAC Function Scores
Time frame: 10 years
WOMAC Stiffness Score
Time frame: 10 years
RAND-12
Time frame: 10 years
Complications
Time frame: 10 years
Revision Rate
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
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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.
Lauren Beaupre, PT, PhD study director
University of Alberta
D William C Johnston, MD, FRCS (C) principal investigator
Alberta Health services
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Secure-Fit™ arc-deposited Hydroxylapatite (HA) shell - surface ceramic and an Alumina Bearing Couple (ABC) ceramic insert and Ceramic C-taper head and Secure-Fit™ arc-deposited hydroxylapatite shell, a Crossfire® insert and a Ceramic C-taper head in people with Total Hip Replacement, run by University of Alberta at 2 sites in Canada.
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 5 inclusion and 4 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 28 Jul 2021. 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Western Ontario McMaster Osteoarthritis Index (WOMAC) Pain Score (time frame: Five Years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2021.