Joint DiseasesNCT00208507
28 mm Ceramic-on-Ceramic Acetabular Cup Total Hip Replacement Study
A study testing 28 mm ceramic head on ceramic acetabular liner. and 28 mm ceramic head on polyethylene liner in people with Joint Diseases, run by DePuy Orthopaedics at 2 sites in United States.
Trial summary
The study is designed to evaluate artificial hips with a 28 mm ceramic head and a ceramic liner to determine whether they perform as well as artificial hips with a 28 mm ceramic head and a polyethylene liner. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Joint Diseases
- What is being tested?
- 28 mm ceramic head on ceramic acetabular liner. and 28 mm ceramic head on polyethylene liner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2003to 5 Jan 2012
- 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
- Non-inflammatory degenerative joint disease. Composite diagnoses of NIDJD include osteoarthritis, avascular necrosis, post-traumatic arthritis, slipped capital femoral epiphysis (SCFE), fracture of the pelvis, and developmental dysplasia.
- X-ray evaluation confirms the presence of NIDJD
- Femoral and acetabular bone stock is sufficient, regarding strength and shape, and is suitable to receive the implants.
- Individuals 20 to 75 years of age at the time of surgery
- Patients with a previous total hip replacement of the contralateral leg who have a pain rating of none or slight and who are at least one year post arthroplasty are eligible for participation in the study.
- Harris Hip Score of 70 or lower
- Pain at least Moderate
Who cannot join
- Presence of a previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) in the hip joint to be operated.
- Previous Girdlestone procedure (resection arthroplasty) or surgical fusion of the hip to be operated.
- Acute femoral neck fracture.
- Above knee amputation of the contralateral and/or ipsilateral leg.
- Patients with bilateral degenerative joint disease requiring staged or simultaneous hip replacements.
- Patients with an existing total hip arthroplasty in the contralateral hip with a Harris Hip pain rating of mild, moderate, marked or totally disabled.
Show all 19Show fewer
- Patients who have undergone total hip arthroplasties in their contralateral hips within the past 12 months.
- Patients with a known allergy to metal (e.g. jewelry).
- Skeletally immature patients (tibial and femoral epiphyses are not closed). Evidence of active infections that may spread to other areas of the body (e.g., osteomyelitis, pyogenic infection of the hip joint, overt infection, urinary tract infection, etc.).
- The presence of highly communicable disease or diseases that may limit follow-up (e.g., immuno-compromised conditions, hepatitis, active tuberculosis, etc.).
- Presence of known metastatic or neoplastic disease.
- Significant neurologic 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's survival or outcome, (e.g., Paget's disease, Charcot's disease).
- Any patient believed to be unwilling or unable to comply with a rehabilitation program for a cementless total hip replacement or who indicates difficulty or inability to return for follow-up visits prescribed by the study protocol.
- Patient is known to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser.
- Any systemic steroid therapy, excluding inhalers, within three months prior to surgery.
- Patients carrying the diagnosis of inflammatory degenerative arthritis (IDJD) to include the following composite diagnoses: rheumatoid arthritis, systemic lupus erythematosus, pigmented villonodular synovitis, juvenile rheumatory arthritis and other arthritic processes of inflammatory or autoimmune etiology.
- Patients requiring structural bone grafts in order to support the prosthetic component(s) or to shape the bone to receive the implant(s).
- Patients who refuse to provide consent to participate in the clinical investigation.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cardinal Orthopaedic Institute
Columbus, Ohio, 43213
Colorado Joint Replacement
Denver, Colorado, 80210
About this study
Official title: Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis Study (28mm)
The study is designed to evaluate artificial hips with a 28 mm ceramic head and a ceramic liner to determine whether they perform as well as artificial hips with a 28 mm ceramic head and a polyethylene liner.
Read the detailed description
Total Hip Arthroplasty (THA) is the surgical reconstruction of the hip joint through replacement of the femoral head and the acetabular articulating surfaces with fixed prosthetic devices. The goals of THA are relief from pain, restoration of function, and correction of deformity. THA is one of the most common adult reconstructive procedures. Over the past 25 years, patients who have needed to have their hip joint replaced, either due to trauma or arthritic disease, typically have had their hip joint bone articular surfaces replaced with a metal hip stem, metal ball head (either stainless steel or chrome cobalt) and a plastic acetabular cup (metal/metal/plastic). While the basic device has remained essentially unchanged over that period, technological advancements in implant designs and materials, and improvements in surgical technique and instrumentation have made THA one of the most durable and successful procedures in medicine. Reproducible, high-quality, short-term and mid-term results are attained regularly, and total hip replacements commonly last 10 to 15 years and longer. The success of this procedure has allowed its expansion into a wider, and often younger and more active population.
In spite of the improvements in THA, little change has occurred for the acetabular cup liner, which is usually made out of Ultra High Molecular Weight Polyethylene plastic (UHMWPe). Because it is plastic and inherently soft and somewhat pliable under load, the cup's articular surface must inevitability wear and produce debris. This biologic response is now thought to be a significant contributor to prosthetic component loosening, a primary failure mode of THR. UHMWPe also degrades with time in the body. As concerns about polyethylene wear and the associated untoward effects of the generated wear debris, and as THA continues to be used in younger and higher-demand patients with increasing life expectancies, interest in ceramic on ceramic total hip prosthesis has been renewed.
An alumina ceramic-on-ceramic acetabular coupling has been employed as an alternative to metal/polyethylene couplings. This ceramic-on-ceramic coupling has many advantages, including the elimination of polyethylene from the device system, wear rates that are appreciably less than those experienced with metal/polyethylene couplings and reduced biologic reactivity. The potential benefits of an alumina ceramic/ceramic bearing are significant.
- Conditions
- Joint Diseases
- Being tested
- 28 mm ceramic head on ceramic acetabular liner., 28 mm ceramic head on polyethylene liner
- Keywords
- Joint Diseases, Non-Inflammatory Degenerative Joint Disease
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
28 mm ceramic head on ceramic acetabular liner.Device
Also called Delta Ceramax™ 28 mm Ceramic-on-Ceramic Acetabular Cup
Total hip replacement with 28 mm ceramic head on ceramic liner articulation
28 mm ceramic head on polyethylene linerDevice
Also called Detla Ceramax 28 mm ceramic femoral head and Marathon polyethylene liner.
Total hip replacement with 28 mm ceramic head on a polyethylene liner articulation.
| Study group | Role | What they receive |
|---|---|---|
| Delta Ceramax Ceramic-on-Ceramic Acetabular Cup System | Active comparator | Total hip replacement with a 28 mm ceramic head and liner. Receives: Device: 28 mm ceramic head on ceramic acetabular liner. |
| Pinnacle™ Acetabular Cup with Marathon® Polyethylene | Active comparator | Total hip replacement with 28 mm ceramic head with a polyethylene liner. Receives: Device: 28 mm ceramic head on polyethylene liner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Total Score
The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. Scores ranges from a minimum of zero to a maximum score of 100. A score of 91-100 is excellent, 81-90 is good, 71-80 is fair, 70 or below is poor. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comfortably sit in a chair are all scored.
Measured: The Harris Hip Total Score evaluation took place at 6 weeks, 6 months, 12 months, and a final evaluation at 24 months or greater (up to 96 months)
Secondary outcomes (1)
Complication Rates
Complication Rates are reported by each type of complication (adverse events/AEs) in the Adverse Events Tab
Measured: The Complication Rates were evaluated at 6 weeks, 6 months, 12 months, and a final evaluation at 24 months or greater (up to 96 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 start1 Apr 2003
- Primary completion5 Jan 2012
- Study completion5 Jan 2012
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 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
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joel Politi, MD, Principal investigator, Cardinal Orthopaedic InstituteDouglas Dennis, MD, Principal investigator, Colorado Joint Replacement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00208507
- Sponsor's protocol ID
- COC 28 mm
- Status last verified
- Oct 2023
- First submitted
- 13 Sep 2005
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis Study (28mm)
- ClinicalTrials.gov ID
- NCT00208507
- Acronym / sponsor ID
- COC 28 mm
- Conditions
- Joint Diseases
- Keywords
- Joint Diseases, Non-Inflammatory Degenerative Joint Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2003 (actual)
- Primary completion
- 5 Jan 2012 (actual)
- Study completion
- 5 Jan 2012 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 16 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to evaluate artificial hips with a 28 mm ceramic head and a ceramic liner to determine whether they perform as well as artificial hips with a 28 mm ceramic head and a polyethylene liner.
Detailed description
Total Hip Arthroplasty (THA) is the surgical reconstruction of the hip joint through replacement of the femoral head and the acetabular articulating surfaces with fixed prosthetic devices. The goals of THA are relief from pain, restoration of function, and correction of deformity. THA is one of the most common adult reconstructive procedures. Over the past 25 years, patients who have needed to have their hip joint replaced, either due to trauma or arthritic disease, typically have had their hip joint bone articular surfaces replaced with a metal hip stem, metal ball head (either stainless steel or chrome cobalt) and a plastic acetabular cup (metal/metal/plastic). While the basic device has remained essentially unchanged over that period, technological advancements in implant designs and materials, and improvements in surgical technique and instrumentation have made THA one of the most durable and successful procedures in medicine. Reproducible, high-quality, short-term and mid-term results are attained regularly, and total hip replacements commonly last 10 to 15 years and longer. The success of this procedure has allowed its expansion into a wider, and often younger and more active population.
In spite of the improvements in THA, little change has occurred for the acetabular cup liner, which is usually made out of Ultra High Molecular Weight Polyethylene plastic (UHMWPe). Because it is plastic and inherently soft and somewhat pliable under load, the cup's articular surface must inevitability wear and produce debris. This biologic response is now thought to be a significant contributor to prosthetic component loosening, a primary failure mode of THR. UHMWPe also degrades with time in the body. As concerns about polyethylene wear and the associated untoward effects of the generated wear debris, and as THA continues to be used in younger and higher-demand patients with increasing life expectancies, interest in ceramic on ceramic total hip prosthesis has been renewed.
An alumina ceramic-on-ceramic acetabular coupling has been employed as an alternative to metal/polyethylene couplings. This ceramic-on-ceramic coupling has many advantages, including the elimination of polyethylene from the device system, wear rates that are appreciably less than those experienced with metal/polyethylene couplings and reduced biologic reactivity. The potential benefits of an alumina ceramic/ceramic bearing are significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delta Ceramax Ceramic-on-Ceramic Acetabular Cup System | Active comparator | Device: 28 mm ceramic head on ceramic acetabular liner.Total hip replacement with a 28 mm ceramic head and liner. |
| Pinnacle™ Acetabular Cup with Marathon® Polyethylene | Active comparator | Device: 28 mm ceramic head on polyethylene linerTotal hip replacement with 28 mm ceramic head with a polyethylene liner. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Non-inflammatory degenerative joint disease. Composite diagnoses of NIDJD include osteoarthritis, avascular necrosis, post-traumatic arthritis, slipped capital femoral epiphysis (SCFE), fracture of the pelvis, and developmental dysplasia.
- X-ray evaluation confirms the presence of NIDJD
- Femoral and acetabular bone stock is sufficient, regarding strength and shape, and is suitable to receive the implants.
- Individuals 20 to 75 years of age at the time of surgery
- Patients with a previous total hip replacement of the contralateral leg who have a pain rating of none or slight and who are at least one year post arthroplasty are eligible for participation in the study.
Key exclusion criteria (19 listed)
- Presence of a previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) in the hip joint to be operated.
- Previous Girdlestone procedure (resection arthroplasty) or surgical fusion of the hip to be operated.
- Acute femoral neck fracture.
- Above knee amputation of the contralateral and/or ipsilateral leg.
- Patients with bilateral degenerative joint disease requiring staged or simultaneous hip replacements.
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 |
|---|---|---|
| 28 mm ceramic head on ceramic acetabular liner.Also: Delta Ceramax™ 28 mm Ceramic-on-Ceramic Acetabular CupTotal hip replacement with 28 mm ceramic head on ceramic liner articulation | Device | Delta Ceramax Ceramic-on-Ceramic Acetabular Cup System |
| 28 mm ceramic head on polyethylene linerAlso: Detla Ceramax 28 mm ceramic femoral head and Marathon polyethylene liner.Total hip replacement with 28 mm ceramic head on a polyethylene liner articulation. | Device | Pinnacle™ Acetabular Cup with Marathon® Polyethylene |
Primary outcome
Harris Hip Total Score
Time frame: The Harris Hip Total Score evaluation took place at 6 weeks, 6 months, 12 months, and a final evaluation at 24 months or greater (up to 96 months)
The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. Scores ranges from a minimum of zero to a maximum score of 100. A score of 91-100 is excellent, 81-90 is good, 71-80 is fair, 70 or below is poor. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comfortably sit in a chair are all scored.
1 secondary outcome
Complication Rates
Time frame: The Complication Rates were evaluated at 6 weeks, 6 months, 12 months, and a final evaluation at 24 months or greater (up to 96 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- 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.
Joel Politi, MD principal investigator
Cardinal Orthopaedic Institute
Douglas Dennis, MD principal investigator
Colorado Joint Replacement
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 28 mm ceramic head on ceramic acetabular liner. and 28 mm ceramic head on polyethylene liner in people with Joint Diseases, run by DePuy Orthopaedics at 2 sites in United States.
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 7 inclusion and 19 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 7 Nov 2023. 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. 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 16 Feb 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?
Harris Hip Total Score (time frame: The Harris Hip Total Score evaluation took place at 6 weeks, 6 months, 12 months, and a final evaluation at 24 months or greater (up to 96 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 7 Nov 2023.