Non-inflammatory Joint DiseasesNCT00208494
Metal on Metal Versus Ceramic on Metal Hip Replacement
A study testing Total Hip Replacement in people with Non-inflammatory Joint Diseases, run by DePuy Orthopaedics at 9 sites in 2 countries.
Trial summary
The purpose of this study is to compare the performance of artificial hips with metal heads and metal sockets to artificial hips with ceramic heads articulating with metal socket components. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Non-inflammatory Joint Diseases
- What is being tested?
- Total Hip Replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Aug 2005to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to (or capable of) provide consent to participate in the clinical investigation prior to the day of the surgery.
- Skeletally mature (tibial and femoral epiphyses are closed)
- Undergoing cementless primary hip replacement surgery for Noninflammatory Degenerative Joint Disease
- Affected hip has a Harris Hip Score of 70 or lower and a Pain rating of Moderate or greater
- Radiographic Parameters:
- X-Ray Evaluation confirms the presence of NIDJD
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- Femoral and acetabular bone stock is sufficient, regarding strength and shape, and is suitable to receive the implants
- No structural bone grafts required to support to prosthetic component(s)or to shape the bone to receive implant(s)
- Willing to have knowledge of treatment arm (CoM or MoM) withheld for a period of 24 months post-operatively unless disclosure is legally and/or medically necessary
- Previous THA in contralateral hip that is greater than one (1) year postoperative and has a Harris Hip pain rating less than MILD
Who cannot join
- Bilateral hip disease with the anticipated need for bilateral hip implant during study participation (i.e., within the next 24 months)
- THA required for the revision of a previously failed THA
- Suffering from inflammatory arthritis
- Prior prosthetic hip replacement
- Previous Girdlestone procedure or surgical fusion in the operative hip joint
- Above knee amputation of either the contralateral or ipsilateral leg
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- Known allergy to metal (e.g. jewelry)
- The presence of highly communicable disease or diseases that may limit follow-up (e.g., immuno-compromised conditions, hepatitis, active tuberculosis, etc.)
- Significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g., muscular dystrophy, multiple sclerosis)
- Conditions that may interfere with the total hip arthroplasty survival or outcome (e.g., Paget's disease, Charcot's disease)
- Unwilling or unable to comply with a rehabilitation program for a cementless THA or difficulty or inability to return for follow-up visits prescribed by the study protocol
- Known to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser
- Previous treatment for renal disease
- Any systemic steroid therapy, excluding inhalers, within three months prior to surgery
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
Anderson Clinic
Alexandria, Virginia, 22306
Study site
Charlotte, North Carolina, 28207
Study site
Cincinnati, Ohio, 45236
Foundation for Musculoskeletal Research and Education
Little Rock, Arkansas, 72203
Study site
Orange, California, 92868
Study site
Palm Bay, Florida, 32905
Study site
Roanoke, Virginia, 24018
Study site
Spokane, Washington, 99218
About this study
Official title: Comparative Study to Evaluate the Safety and Efficacy of the DePuy Ceramic-on-metal Total Hip Prosthesis Versus the DePuy Metal-on-metal Total Hip Prosthesis Through Clinical and Radiographical Data
The purpose of this study is to compare the performance of artificial hips with metal heads and metal sockets to artificial hips with ceramic heads articulating with metal socket components. The success of the total hip arthroplasty (THA) will be based upon all of the following clinical and radiographic criteria being met at the two-year evaluation: (1) the patient's clinical results as measured using modified Harris Hip evaluation rating system, and the absence of a complication that requires the surgical removal or replacement of a component; and (2) radiographic findings at study endpoint (i.e., two years follow-up). Clinical and radiographic success at two (2) years postoperative is required for the study hip to be deemed successful.
Read the detailed description
This study is a prospective, multi-center, randomized, single blind, controlled clinical investigation comparing the safety and efficacy of the cementless Ceramic on Metal total hip prostheses versus the cementless Metal on Metal total hip prostheses.
- Conditions
- Non-inflammatory Joint Diseases
- Being tested
- Total Hip Replacement
- Keywords
- Non-Inflammatory Degenerative Joint Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ReplacementDevice
Also called Biolox Delta head; Ultamet insert; Pinnacle Acetabular shell
Total hip replacement
Total hip replacementDevice
Also called CoCr M-head, Ultamet insert, Pinnacle Acetabular shell
Total hip replacement
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Ceramic-on-metal total hip implant Receives: Device: Total Hip Replacement |
| B | Active comparator | Metal-on-metal total hip implant Receives: Device: Total hip replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Success/Failure
The composite success/failure of the implant was made up of radiographic, clinical and revision data. Radiographic success was determined by femoral subsidence =/< 2mm, acetabular migration =/< 2mm, cup inclination =/< 4°, no acetabular or femoral osteolysis, and acetabular and femoral lucencies less than 50% of visible porous coating. Clinical success was determined by a Harris Hip score equal to or greater than 80. A hip (patient) was considered to be a composite success at study endpoint if it was a radiographic and clinical success and no revision of any component had taken place.
Measured: At 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionDec 2008
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-inflammatory Joint DiseasesStudies 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
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Scott, MD, Principal investigator, Orthopaedic Specialty ClinicPatrick G Kirk, MD, Principal investigatorShekhar S Desai, MD, Principal investigatorCharles A Engh, Jr., MD, Principal investigator, Anderson ClinicAjai Cadambi, MD, Principal investigator, Adult Orthopaedic Reconstruction Texas Hip and Knee CenterC L Barnes, MD, Principal investigator, Foundation for Musculoskeletal Research & Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00208494
- Sponsor's protocol ID
- 03062
- Status last verified
- Aug 2013
- First submitted
- 13 Sep 2005
- Last updated
- 14 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study to Evaluate the Safety and Efficacy of the DePuy Ceramic-on-metal Total Hip Prosthesis Versus the DePuy Metal-on-metal Total Hip Prosthesis Through Clinical and Radiographical Data
- ClinicalTrials.gov ID
- NCT00208494
- Acronym / sponsor ID
- 03062
- Conditions
- Non-inflammatory Joint Diseases
- Keywords
- Non-Inflammatory Degenerative Joint Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 4 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the performance of artificial hips with metal heads and metal sockets to artificial hips with ceramic heads articulating with metal socket components. The success of the total hip arthroplasty (THA) will be based upon all of the following clinical and radiographic criteria being met at the two-year evaluation: (1) the patient's clinical results as measured using modified Harris Hip evaluation rating system, and the absence of a complication that requires the surgical removal or replacement of a component; and (2) radiographic findings at study endpoint (i.e., two years follow-up). Clinical and radiographic success at two (2) years postoperative is required for the study hip to be deemed successful.
Detailed description
This study is a prospective, multi-center, randomized, single blind, controlled clinical investigation comparing the safety and efficacy of the cementless Ceramic on Metal total hip prostheses versus the cementless Metal on Metal total hip prostheses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Device: Total Hip ReplacementCeramic-on-metal total hip implant |
| B | Active comparator | Device: Total hip replacementMetal-on-metal total hip implant |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able to (or capable of) provide consent to participate in the clinical investigation prior to the day of the surgery.
- Skeletally mature (tibial and femoral epiphyses are closed)
- Undergoing cementless primary hip replacement surgery for Noninflammatory Degenerative Joint Disease
- Affected hip has a Harris Hip Score of 70 or lower and a Pain rating of Moderate or greater
- Radiographic Parameters:
Key exclusion criteria (14 listed)
- Bilateral hip disease with the anticipated need for bilateral hip implant during study participation (i.e., within the next 24 months)
- THA required for the revision of a previously failed THA
- Suffering from inflammatory arthritis
- Prior prosthetic hip replacement
- Previous Girdlestone procedure or surgical fusion in the operative hip joint
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 ReplacementAlso: Biolox Delta head; Ultamet insert; Pinnacle Acetabular shellTotal hip replacement | Device | A |
| Total hip replacementAlso: CoCr M-head, Ultamet insert, Pinnacle Acetabular shellTotal hip replacement | Device | B |
Primary outcome
Composite Success/Failure
Time frame: At 24 months
The composite success/failure of the implant was made up of radiographic, clinical and revision data. Radiographic success was determined by femoral subsidence =/< 2mm, acetabular migration =/< 2mm, cup inclination =/< 4°, no acetabular or femoral osteolysis, and acetabular and femoral lucencies less than 50% of visible porous coating. Clinical success was determined by a Harris Hip score equal to or greater than 80. A hip (patient) was considered to be a composite success at study endpoint if it was a radiographic and clinical success and no revision of any component had taken place.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David Scott, MD principal investigator
Orthopaedic Specialty Clinic
Patrick G Kirk, MD principal investigator
Shekhar S Desai, MD principal investigator
9 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 Joint Diseases, run by DePuy Orthopaedics at 9 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 14 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 14 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Yes. Results are posted in the registry (first posted 4 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Composite Success/Failure (time frame: At 24 months). 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 14 Aug 2013.