Non-inflammatory Degenerative Joint DiseaseNCT00962351
Metal Ion Release From an FDA-Approved Metal-on-Metal Total Hip Replacement Implant
A study testing Total Hip Replacement in people with Non-inflammatory Degenerative Joint Disease, run by Anderson Orthopaedic Research Institute at 2 sites in 2 countries.
Trial summary
This is a multi-center, randomized study to compare blood and urine cobalt, chromium, and titanium ion levels of a metal-on-metal articular bearing coupled with two different head sizes to that of a conventional metal-on-polyethylene bearing. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Non-inflammatory Degenerative Joint Disease
- What is being tested?
- Total Hip Replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2003to Oct 2013
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing cementless primary total hip replacement
- Receiving acetabular cup of 52mm or greater
- Preoperative level of function and pain same as for conventional hip replacement
- Likelihood of obtaining relief of pain and improved function
- Full skeletal maturity
- Ability to follow instructions
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- Good general health
- Willing to return for follow-up evaluations
- X-ray evaluation confirming the presence of NIDJD
- Femoral and acetabular bone stock that is sufficient, regarding strength and shape, and suitable to receive the implants
Who cannot join
- Age less than 40 years or greater than 80 years at time of surgery
- Patients templated to receive an acetabular component smaller than 52mm in diameter
- Presence of a previous prosthetic hip replacement device in the hip joint to be operated
- Previous girdlestone procedure or surgical fusion of the hip to be operated
- Acute femoral neck fracture
- Above knee amputation of the contralateral and/or ipsilateral leg
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- Patients with a diagnosis of inflammatory degenerative arthritis
- Skeletally immature
- Evidence of active infections that may spread to other areas of the body
- The presence of a highly communicable disease that may limit follow-up
- Presence of known active metastatic or neoplastic disease
- Significant neurologic or musculoskeletal disorders or disease that may adversely affect gait or weightbearing
- Any previous hip surgery or conditions that may interfere with the total hip replacement's survival or outcome
- Any patient believed to be unwilling or unable to comply with a rehabilitation program for a cementless total hip replacement or indicates difficulty to return for follow-up
- Patient is know to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser
- Any patient who qualifies for inclusion in the study but refuses consent to participate in the study
- Any steroid therapy, local or systemic, within three months prior to surgery
- Patient requiring structural bone grafts in order to support the prosthetic components or to shape the bone to receive the implants
- Patient has known allergies to metal, e.g., jewelry
- Any patient not meeting all radiographic and clinical parameters for inclusion
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Anderson Orthopaedic Research Institute
Alexandria, Virginia, 22306
Canada1 site
Department of Orthopaedic Surgery, University of Western Ontario
London, Ontario, N6A5A5
About this study
Official title: Metal Ion Release From an FDA Approved Metal-on-Metal Hip Replacement Implant: A Multi-Center, Randomized Clinical Trial
This is a multi-center, randomized study to compare blood and urine cobalt, chromium, and titanium ion levels of a metal-on-metal articular bearing coupled with two different head sizes to that of a conventional metal-on-polyethylene bearing.
- Being tested
- Total Hip Replacement
- Keywords
- total hip replacement, primary cementless total hip arthroplasty, metal ion, metal-on-metal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ReplacementProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Metal-on-Polyethylene | Other | Not described Receives: Procedure: Total Hip Replacement |
| Metal-on-Metal, 28mm femoral head | Other | Not described Receives: Procedure: Total Hip Replacement |
| Metal-on-Metal, 36mm femoral head | Other | Not described Receives: Procedure: Total Hip Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
cobalt, chromium, and titanium ion levels in blood and urine
Measured: Pre-op, 6 months, 1 year, 2 years, 3 years, 5 years
Secondary outcomes (2)
Hip function
Measured: Pre-op, 6 months,1 year, 2 years, 3 years, 5 years
Durability
Measured: 6 months, 1 year, 2 years, 3 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2009 (estimated)
- Study startOct 2003
- Primary completionOct 2010
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-inflammatory Degenerative Joint DiseaseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anderson Orthopaedic Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada, DePuy Orthopaedics
- Responsible party
- Principal investigator, C. Anderson Engh, Jr., MD, Anderson Orthopaedic Research Institute
- Investigators
- C. Anderson Engh, Jr., MD, Principal investigator, Anderson Orthopaedic Research InstituteSteven J. MacDonald, MD, Principal investigator, Department of Orthopaedic Surgery, University of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962351
- Sponsor's protocol ID
- AORI2009-0100
- Status last verified
- Aug 2015
- First submitted
- 19 Aug 2009
- Last updated
- 17 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Engh CA Jr, MacDonald SJ, Sritulanondha S, Thompson A, Naudie D, Engh CA. 2008 John Charnley award: metal ion levels after metal-on-metal total hip arthroplasty: a randomized trial. Clin Orthop Relat Res. 2009 Jan;467(1):101-11. doi: 10.1007/s11999-008-0540-9. Epub 2008 Oct 15.
PubMed 18855089
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metal Ion Release From an FDA Approved Metal-on-Metal Hip Replacement Implant: A Multi-Center, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00962351
- Acronym / sponsor ID
- AORI2009-0100
- Keywords
- total hip replacement, primary cementless total hip arthroplasty, metal ion, metal-on-metal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Anderson Orthopaedic Research InstituteUniversity, hospital or other
- Collaborators
- University of Western Ontario, Canada, DePuy Orthopaedics
- Study start
- Oct 2003
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 20 Aug 2009 (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 is a multi-center, randomized study to compare blood and urine cobalt, chromium, and titanium ion levels of a metal-on-metal articular bearing coupled with two different head sizes to that of a conventional metal-on-polyethylene bearing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metal-on-Polyethylene | Other | Procedure: Total Hip Replacement |
| Metal-on-Metal, 28mm femoral head | Other | Procedure: Total Hip Replacement |
| Metal-on-Metal, 36mm femoral head | Other | Procedure: Total Hip Replacement |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Undergoing cementless primary total hip replacement
- Receiving acetabular cup of 52mm or greater
- Preoperative level of function and pain same as for conventional hip replacement
- Likelihood of obtaining relief of pain and improved function
- Full skeletal maturity
Key exclusion criteria (20 listed)
- Age less than 40 years or greater than 80 years at time of surgery
- Patients templated to receive an acetabular component smaller than 52mm in diameter
- Presence of a previous prosthetic hip replacement device in the hip joint to be operated
- Previous girdlestone procedure or surgical fusion of the hip to be operated
- Acute femoral neck fracture
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 |
|---|---|---|
| Total Hip Replacement | Procedure or surgery | Metal-on-Metal, 28mm femoral head, Metal-on-Metal, 36mm femoral head, Metal-on-Polyethylene |
Primary outcome
cobalt, chromium, and titanium ion levels in blood and urine
Time frame: Pre-op, 6 months, 1 year, 2 years, 3 years, 5 years
2 secondary outcomes
Hip function
Time frame: Pre-op, 6 months,1 year, 2 years, 3 years, 5 years
Durability
Time frame: 6 months, 1 year, 2 years, 3 years, 5 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 17 Aug 2015.
- Results publication: PubMed 18855089Engh CA Jr, MacDonald SJ, Sritulanondha S, Thompson A, Naudie D, Engh CA. 2008 John Charnley award: metal ion levels after metal-on-metal total hip arthroplasty: a randomized trial. Clin Orthop Relat Res. 2009 Jan;467(1):101-11. doi: 10.1007/s11999-008-0540-9. Epub 2008 Oct 15.
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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.
C. Anderson Engh, Jr., MD principal investigator
Anderson Orthopaedic Research Institute
Steven J. MacDonald, MD principal investigator
Department of Orthopaedic Surgery, University of Western Ontario
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Hip Replacement in people with Non-inflammatory Degenerative Joint Disease, run by Anderson Orthopaedic Research Institute at 2 sites in 2 countries.
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 10 inclusion and 20 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 17 Aug 2015. 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 United States, 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?
cobalt, chromium, and titanium ion levels in blood and urine (time frame: Pre-op, 6 months, 1 year, 2 years, 3 years, 5 years). 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 NCT00962351, which also lists 1 linked publication.
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 17 Aug 2015.