Arthroplasty ComplicationsNCT03900039
An Assessment of 4 Different Bearing Types in Hip Replacement Types to Analsye the Lowest Wear Rates of Polyethylene
A study testing Highly Cross Linked Polyethylene and oxidized zirconium femoral head in people with Arthroplasty Complications and Hip Arthritis, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The aim of the study is to assess the ideal bearing surfaces in hip replacement by comparing 4 different combinations. In a hip replacement this means what the head and the socket liner are made of. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthroplasty Complications, Hip Arthritis
- What is being tested?
- Highly Cross Linked Polyethylene and oxidized zirconium femoral head
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 26 Jul 2005to 26 Mar 2019
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All adults with no history of cancer, infection of the hip and with the capacity to make informed consent for the trial
Who cannot join
- those under the age of 18 and over 65. Those with a history of cancer and infection. Those without the capacity to make an informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Control Trial of Four Bearing Surfaces in Primary Total Hip Arthroplasty in Patients Over the Age of 18 Years
The aim of the study is to assess the ideal bearing surfaces in hip replacement by comparing 4 different combinations. In a hip replacement this means what the head and the socket liner are made of.
Read the detailed description
In hip replacements, arguably the most important thing for survivorship is what rubs against what.
Traditionally surgeons used metal (Cobalt-Chrome) against a conventional polyethylene (plastic). More recently (around 15 years ago) a newer more dense type of polyethylene (called XLPE) had been developed and a new type of head called Oxidized Zirconium was also developed.
In this trial, adults who were undergoing hip replacements were randomized assigned into one of the four groups:
Group 1: old plastic vs metal head Group 2: Old plastic against Oxidized Zirconium Group 3: New plastic versus metal head Group 4 New plastic vs Oxidized Zirconium
All patients were followed up for a minimum of 10 years to assess which group wore the most amount of polyethylene and which group had the best survival rate.
- Conditions
- Arthroplasty Complications, Hip Arthritis
- Being tested
- Highly Cross Linked Polyethylene and oxidized zirconium femoral head
- Keywords
- Hip arthroplasty, Tribology, wear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Highly Cross Linked Polyethylene and oxidized zirconium femoral headDevice
Also called Varilast - from Smith & Nephew
Differing bearing surfaces:
- Conventional polyethylene versus cobalt Chrome heads
- Conventional polyethylene versus Oxidized Zirconium heads
- Highly Cross-linked polyethylene versus Cobalt Chrome heads
- Highly Cross-linked polyethylene versus Oxidized Zirconium heads
| Study group | Role | What they receive |
|---|---|---|
| Conventional Polyethylene versus metal head | Active comparator | This is the more conventional group bearing surfaces Receives: Device: Highly Cross Linked Polyethylene and oxidized zirconium femoral head |
| Conventional Polyethylene versus oxidized zirconium head | Experimental | This group uses the more conventional polyethylene against the newer head Receives: Device: Highly Cross Linked Polyethylene and oxidized zirconium femoral head |
| Newer Cross linked Polyethylene metal head | Experimental | In this group we continued with the conventional polyethylene, but added in the new type of head (oxidized zirconium) Receives: Device: Highly Cross Linked Polyethylene and oxidized zirconium femoral head |
| Newer Cross linked Polyethylene versus oxidized zirconium head | Experimental | In this group, we added both the new head and the new polyethylene Receives: Device: Highly Cross Linked Polyethylene and oxidized zirconium femoral head |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wear rates of polyethylene over 10 years
Linear and volumetric wear were measured in the most recent radiographs using a computer software package (Polyware Rev. 5; Draftware).
Measured: Over 10 years of wear rates
Secondary outcomes (1)
Survivorship of implant combinations
Assess linear and volumetric wear to assess if those bearing surfaces require to be revised (exchanged) during the experimental period in one group more than the others
Measured: over 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start26 Jul 2005
- Primary completion26 Jul 2018
- Study completion26 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty ComplicationsStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900039
- Sponsor's protocol ID
- #04-025
- Status last verified
- Apr 2019
- First submitted
- 28 Mar 2019
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Atrey A, Ward SE, Khoshbin A, Hussain N, Bogoch E, Schemitsch EH, Waddell JP. Ten-year follow-up study of three alternative bearing surfaces used in total hip arthroplasty in young patients: a prospective randomised controlled trial. Bone Joint J. 2017 Dec;99-B(12):1590-1595. doi: 10.1302/0301-620X.99B12.BJJ-2017-0353.R1.
PubMed 29212681Rames RD, Stambough JB, Pashos GE, Maloney WJ, Martell JM, Clohisy JC. Fifteen-Year Results of Total Hip Arthroplasty With Cobalt-Chromium Femoral Heads on Highly Cross-Linked Polyethylene in Patients 50 Years and Less. J Arthroplasty. 2019 Jun;34(6):1143-1149. doi: 10.1016/j.arth.2019.01.071. Epub 2019 Feb 5.
PubMed 30808529
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Four Bearing Surfaces in Primary Total Hip Arthroplasty in Patients Over the Age of 18 Years
- ClinicalTrials.gov ID
- NCT03900039
- Acronym / sponsor ID
- #04-025
- Conditions
- Arthroplasty Complications, Hip Arthritis
- Keywords
- Hip arthroplasty, Tribology, wear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 26 Jul 2005 (actual)
- Primary completion
- 26 Jul 2018 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 2 Apr 2019 (actual)
- 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.
The aim of the study is to assess the ideal bearing surfaces in hip replacement by comparing 4 different combinations. In a hip replacement this means what the head and the socket liner are made of.
Detailed description
In hip replacements, arguably the most important thing for survivorship is what rubs against what.
Traditionally surgeons used metal (Cobalt-Chrome) against a conventional polyethylene (plastic). More recently (around 15 years ago) a newer more dense type of polyethylene (called XLPE) had been developed and a new type of head called Oxidized Zirconium was also developed.
In this trial, adults who were undergoing hip replacements were randomized assigned into one of the four groups:
Group 1: old plastic vs metal head Group 2: Old plastic against Oxidized Zirconium Group 3: New plastic versus metal head Group 4 New plastic vs Oxidized Zirconium
All patients were followed up for a minimum of 10 years to assess which group wore the most amount of polyethylene and which group had the best survival rate.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Conventional Polyethylene versus metal head | Active comparator | Device: Highly Cross Linked Polyethylene and oxidized zirconium femoral headThis is the more conventional group bearing surfaces |
| Conventional Polyethylene versus oxidized zirconium head | Experimental | Device: Highly Cross Linked Polyethylene and oxidized zirconium femoral headThis group uses the more conventional polyethylene against the newer head |
| Newer Cross linked Polyethylene metal head | Experimental | Device: Highly Cross Linked Polyethylene and oxidized zirconium femoral headIn this group we continued with the conventional polyethylene, but added in the new type of head (oxidized zirconium) |
| Newer Cross linked Polyethylene versus oxidized zirconium head | Experimental | Device: Highly Cross Linked Polyethylene and oxidized zirconium femoral headIn this group, we added both the new head and the new polyethylene |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adults with no history of cancer, infection of the hip and with the capacity to make informed consent for the trial
Key exclusion criteria (1 listed)
- those under the age of 18 and over 65. Those with a history of cancer and infection. Those without the capacity to make an informed consent.
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 |
|---|---|---|
| Highly Cross Linked Polyethylene and oxidized zirconium femoral headAlso: Varilast - from Smith & NephewDiffering bearing surfaces: 1. Conventional polyethylene versus cobalt Chrome heads 2. Conventional polyethylene versus Oxidized Zirconium heads 3. Highly Cross-linked polyethylene versus Cobalt Chrome heads 4. Highly Cross-linked polyethylene versus Oxidized Zirconium heads | Device | Conventional Polyethylene versus metal head, Conventional Polyethylene versus oxidized zirconium head, Newer Cross linked Polyethylene metal head, Newer Cross linked Polyethylene versus oxidized zirconium head |
Primary outcome
Wear rates of polyethylene over 10 years
Time frame: Over 10 years of wear rates
Linear and volumetric wear were measured in the most recent radiographs using a computer software package (Polyware Rev. 5; Draftware).
1 secondary outcome
Survivorship of implant combinations
Time frame: over 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 2 Apr 2019.
- Background: PubMed 29212681Atrey A, Ward SE, Khoshbin A, Hussain N, Bogoch E, Schemitsch EH, Waddell JP. Ten-year follow-up study of three alternative bearing surfaces used in total hip arthroplasty in young patients: a prospective randomised controlled trial. Bone Joint J. 2017 Dec;99-B(12):1590-1595. doi: 10.1302/0301-620X.99B12.BJJ-2017-0353.R1.
- Results publication: PubMed 30808529Rames RD, Stambough JB, Pashos GE, Maloney WJ, Martell JM, Clohisy JC. Fifteen-Year Results of Total Hip Arthroplasty With Cobalt-Chromium Femoral Heads on Highly Cross-Linked Polyethylene in Patients 50 Years and Less. J Arthroplasty. 2019 Jun;34(6):1143-1149. doi: 10.1016/j.arth.2019.01.071. Epub 2019 Feb 5.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Highly Cross Linked Polyethylene and oxidized zirconium femoral head in people with Arthroplasty Complications and Hip Arthritis, run by Unity Health Toronto at 1 site 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 1 inclusion and 1 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 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Wear rates of polyethylene over 10 years (time frame: Over 10 years of wear rates). 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 NCT03900039, which also lists 2 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 2 Apr 2019.