OsteoarthritisPhase 4MOMNCT01422564
Metal on Metal Versus Metal on Highly Crossed Linked Polyethylene Sytem
A Phase 4 study testing Metal on Metal Hip System and Highly Cross Linked Polyethylene cup System in people with Osteoarthritis and Avascular Necrosis, run by Nova Scotia Health Authority.
Trial summary
This trial will evaluate the 36mm or greater metal head on metal hip system and compare it to the 32mm or 28mm metal head on polyethylene (liner) hip system in patients receiving a primary cementless total hip replacement. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis
- What is being tested?
- Metal on Metal Hip System and Highly Cross Linked Polyethylene cup System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Dec 2010
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Male and non-pregnant female subjects 65 years of age or older
- Subjects undergoing cementless hip arthroplasty. If a press fit metal articulation acetabulum is not possible; the modular cup system will be utilized with screw fixation and a metal head of the greatest diameter deemed appropriate and safe for the patient will be utilized.(At the discretion of the surgeon). The cup in this situation may have a metal or poly articulation. The patient will be followed as an intent to treat (the patient will be evaluated and included in the group as randomized)
- Subjects with, but not limited to, original diagnoses of osteoarthritis, avascular necrosis, rheumatoid arthritis, congenital dysplasia of the hip, ankylosing spondylitis, posttraumatic arthritis, and traumatic injury to the hip joint.
- Subjects who are able and willing to understand the conditions of informed consent, to participate in the study according to the protocol for the length of the expected term of follow-up, and to follow their physician's directions.
Who cannot join
- Subjects undergoing hip arthroplasty using a cemented femoral component and/or a bipolar prosthesis.
- Subjects with gross obesity, >45% over ideal body weight for age and height. Refer to Appendix A, Obesity Table.
- Subjects with active infections.
- Subjects with malignancy in the area of the involved hip joint.
- Subjects with a neuromuscular deficit that interferes with the subject's ability to limit weight bearing or places an extreme load on the implant during the healing period.
- Subjects with a diagnosis of Fibromyalgia
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- Female subjects who are pregnant or may be pregnant.
- Subjects whom, as judged by the surgeon, are not capable of understanding the informed consent or the requirements of the protocol, or are reasonably unlikely to be compliant with the prescribed postoperative routine and the follow-up evaluation schedule.
- Subjects who have a known sensitivity to device materials.
About this study
Official title: A Randomized Multicentre Clinical Trial Comparing The Metal on Metal Hip System Versus The Metal on Highly Crossed Linked Polyethylene System
This trial will evaluate the 36mm or greater metal head on metal hip system and compare it to the 32mm or 28mm metal head on polyethylene (liner) hip system in patients receiving a primary cementless total hip replacement.
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Congenital Dysplasia of the Hip, Ankylosing Spondylitis, Post-traumatic; Arthrosis
- Being tested
- Metal on Metal Hip System, Highly Cross Linked Polyethylene cup System
- Medical subject headings
- Osteoarthritis, Osteonecrosis, Arthritis, Rheumatoid, Hip Dislocation, Congenital, Spondylitis, Ankylosing, Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metal on Metal Hip SystemDevice
Also called Depuy ASR
Total hip arthroplasty with a metal on metal component system
Highly Cross Linked Polyethylene cup SystemDevice
Also called Depuy Pinnacle Cup and Marathon liner
Total hip arthroplasty with Highly Cross Linked Polyethylene cup System
| Study group | Role | What they receive |
|---|---|---|
| Metal on Metal | Active comparator | Metal on Metal articulation system Receives: Device: Metal on Metal Hip System |
| HCLPC | Active comparator | THA using Highly Cross Linked Polyethylene cup System Receives: Device: Highly Cross Linked Polyethylene cup System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revision Rate
Measured: 4 years
Secondary outcomes (6)
Wear and osteolysis
Measured: 5-15 years
Harris Hip Score
Measured: immediate post-op, 6 months, 1 year, 2 years, 4 years
Dislocation Rate
Measured: 4 years
Complication Rate
All complications
Measured: 4 years
Gait Analysis
Using the Walkabout portable gait monitor
Measured: 6 months and 1 year post-op
Metal Ions
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2011 (estimated)
- Study startJan 2007
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Components were recalled by Depuy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Sponsor
- Investigators
- Ross K Leighton, MD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422564
- Sponsor's protocol ID
- RL 006
- Acronym
- MOM
- Status last verified
- Mar 2014
- First submitted
- 12 Aug 2011
- Last updated
- 15 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multicentre Clinical Trial Comparing The Metal on Metal Hip System Versus The Metal on Highly Crossed Linked Polyethylene System
- ClinicalTrials.gov ID
- NCT01422564
- Acronym / sponsor ID
- MOM / RL 006
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Congenital Dysplasia of the Hip, Ankylosing Spondylitis, Post-traumatic; Arthrosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Components were recalled by Depuy
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- Jan 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 24 Aug 2011 (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.
This trial will evaluate the 36mm or greater metal head on metal hip system and compare it to the 32mm or 28mm metal head on polyethylene (liner) hip system in patients receiving a primary cementless total hip replacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metal on Metal | Active comparator | Device: Metal on Metal Hip SystemMetal on Metal articulation system |
| HCLPC | Active comparator | Device: Highly Cross Linked Polyethylene cup SystemTHA using Highly Cross Linked Polyethylene cup System |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Male and non-pregnant female subjects 65 years of age or older
- Subjects undergoing cementless hip arthroplasty. If a press fit metal articulation acetabulum is not possible; the modular cup system will be utilized with screw fixation and a metal head of the greatest diameter deemed appropriate and safe for the patient will be utilized.(At the discretion of the surgeon). The cup in this situation may have a metal or poly articulation. The patient will be followed as an intent to treat (the patient will be evaluated and included in the group as randomized)
- Subjects with, but not limited to, original diagnoses of osteoarthritis, avascular necrosis, rheumatoid arthritis, congenital dysplasia of the hip, ankylosing spondylitis, posttraumatic arthritis, and traumatic injury to the hip joint.
- Subjects who are able and willing to understand the conditions of informed consent, to participate in the study according to the protocol for the length of the expected term of follow-up, and to follow their physician's directions.
Key exclusion criteria (9 listed)
- Subjects undergoing hip arthroplasty using a cemented femoral component and/or a bipolar prosthesis.
- Subjects with gross obesity, >45% over ideal body weight for age and height. Refer to Appendix A, Obesity Table.
- Subjects with active infections.
- Subjects with malignancy in the area of the involved hip joint.
- Subjects with a neuromuscular deficit that interferes with the subject's ability to limit weight bearing or places an extreme load on the implant during the healing period.
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 |
|---|---|---|
| Metal on Metal Hip SystemAlso: Depuy ASRTotal hip arthroplasty with a metal on metal component system | Device | Metal on Metal |
| Highly Cross Linked Polyethylene cup SystemAlso: Depuy Pinnacle Cup and Marathon linerTotal hip arthroplasty with Highly Cross Linked Polyethylene cup System | Device | HCLPC |
Primary outcome
Revision Rate
Time frame: 4 years
6 secondary outcomes
Wear and osteolysis
Time frame: 5-15 years
Harris Hip Score
Time frame: immediate post-op, 6 months, 1 year, 2 years, 4 years
Dislocation Rate
Time frame: 4 years
Complication Rate
Time frame: 4 years
Gait Analysis
Time frame: 6 months and 1 year post-op
Metal Ions
Time frame: 4 years
Results and safety
The study was stopped early (reason given: Components were recalled by Depuy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
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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.
Ross K Leighton, MD principal investigator
Nova Scotia Health Authority
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metal on Metal Hip System and Highly Cross Linked Polyethylene cup System in people with Osteoarthritis and Avascular Necrosis, run by Nova Scotia Health Authority.
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 4 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: stopped early, as of the sponsor's last update on 15 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Components were recalled by Depuy). Results are not available in the source record.
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?
Revision Rate (time frame: 4 years). 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 15 May 2015.