Non-inflammatory Degenerative Joint DiseaseNCT00953719

36 mm Ceramic-on-Ceramic Acetabular Cup Total Hip Replacement

A study testing 36 mm ceramic head on a ceramic acetabular liner and 28 mm ceramic head on a polyethylene acetabular liner in people with Non-inflammatory Degenerative Joint Disease, run by DePuy Orthopaedics at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is a supplement to the 28 mm Ceramic-on-Ceramic study which was designed to evaluate artificial hips with a 28 mm ceramic head and 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: Non-inflammatory Degenerative Joint Disease
What is being tested?: 36 mm ceramic head on a ceramic acetabular liner and 28 mm ceramic head on a polyethylene acetabular liner
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 243 participants
Where: 5 sitesUnited States
Study dates: 1 Apr 2003to 1 Jul 2013
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 21Show 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.
Surgical replacement requires the use of an acetabular liner and femoral head greater or smaller than a 36mm diameter

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Study site
Alexandria, Virginia, 22306
Cardinal Orthopaedic Institute
Columbus, Ohio, 43213
Colorado Joint Replacement
Denver, Colorado, 80210
Study site
Sacramento, California, 95816
Study site
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: Delta Ceramax 36 mm Ceramic-on-Ceramic Acetabular Cup Prosthesis Study

This arm of the study is designed to compare a 36 mm ceramic head and sleeve with a subset of the control (28mm ceramic head and a polyethylene sleeve) from the original study (G030075) (NCT#00208507) with additional follow-up, to determine if they perform as well.

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: Non-inflammatory Degenerative Joint Disease
Being tested: 36 mm ceramic head on a ceramic acetabular liner, 28 mm ceramic head on a polyethylene acetabular liner
Keywords: Hip arthroplasty, Acetabular cup, Ceramic-on-polyethylene

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

36 mm ceramic head on a ceramic acetabular linerDevice
Also called Delta Ceramax head on a ceramic liner.
Total hip replacement with a 36 mm ceramic head on a ceramic liner
28 mm ceramic head on a polyethylene acetabular linerDevice
Also called Delta Ceramax head on a polyethylene liner
Total hip replacement with a 28 mm ceramic head on a polyethylene liner.

Study groups in NCT00953719
Study group	Role	What they receive
36 mm	Active comparator	36 mm ceramic head on ceramic acetabular liner Receives: Device: 36 mm ceramic head on a ceramic acetabular liner
28 mm ceramic-on-polyethylene	Other	28 mm ceramic-on-polyethylene historical control Receives: Device: 28 mm ceramic head on a polyethylene acetabular liner

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Harris Hip Score
The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. 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. The Total Harris Hip Score is a sum of its subscores (Pain, Function, Activities, Deformity, and Range of Motion).
Measured: At final follow-up visit, 24 months or later, up to 72 months

Secondary outcomes (7)

Harris Hip Subscale Score: Pain
The Harris Hip's pain subscale is a numeric value from 0 to 44. A lower score indicates more pain; a score of 44 indicates no pain.
Measured: At final follow-up visit, 24 months or later, up to 72 months
Harris Hip Subscale Score: Function
The Harris Hip's function subscale is a numeric value from 0 to 33. A lower score indicates less function; a score of 33 indicates no limitations in function level.
Measured: At final follow-up visit, 24 months or later, up to 72 months
Harris Hip Subscale Score: Activities
The Harris Hip's Activities subscale is a numeric value from 0 to 14. A lower score indicates a lower ability to perform daily activities; a score of 14 indicates no limitations in daily activities.
Measured: At final follow-up visit, 24 months or later, up to 72 months
Harris Hip Subscale Score: Deformity
The Harris Hip's Deformity subscale is a numeric value from 0 to 4. A lower score indicates more deformity; a score of 4 indicates no deformity.
Measured: At final follow-up visit, 24 months or later, up to 72 months
Harris Hip Subscale Score: Range of Motion
The Harris Hip's Range of Motion subscale is a numeric value from 0 to 5. A lower score indicates a lower range of motion; a score of 5 indicates full range of motion.
Measured: At final follow-up visit, 24 months or later, up to 72 months
Harris Hip Score Longitudinal Analysis
The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon, with a range of 0 to 100. Lower scores indicate a worse outcome and a score of 100 is the best possible outcome. Longitudinal analysis (repeated measures) was performed to compare post-operative Harris Hip sores over time.
Measured: 6 week, 6 month, 12 month, 24 month, 36 month, and 48 months post-operatively
Proportion of Composite Successes
A subject was deemed to be a composite success at 24 months or greater if at the time of last clinical follow-up there had not been a revision of any THA components, the latest Harris Hip score was 80 or greater, and on the latest radiographic evaluation there were no radiolucencies greater than 2mm, no evidence of acetabular migration greater than 4mm, no change in acetabular shell inclination angle greater than 4 degrees, and no osteolysis.
Measured: At final follow-up visit, 24 months or later, up to 72 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20031 Jul 2013

First posted6 Aug 2009 (estimated)
Study start1 Apr 2003
Primary completion1 Aug 2008
Study completion1 Jul 2013

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 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 243 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00953719
Sponsor's protocol ID: COC 36 mm
Status last verified: Apr 2019
First submitted: 3 Jun 2009
Last updated: 10 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Non-inflammatory Degenerative Joint Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Delta Ceramax 36 mm Ceramic-on-Ceramic Acetabular Cup Prosthesis Study
ClinicalTrials.gov ID: NCT00953719
Acronym / sponsor ID: COC 36 mm
Conditions: Non-inflammatory Degenerative Joint Disease
Keywords: Hip arthroplasty, Acetabular cup, Ceramic-on-polyethylene
Study type: Interventional
Recruitment status: Completed
Enrolment: 243 participants (actual)
Lead sponsor: DePuy OrthopaedicsIndustry (pharma, biotech, devices)
Study start: 1 Apr 2003 (actual)
Primary completion: 1 Aug 2008 (actual)
Study completion: 1 Jul 2013 (actual)
First posted: 6 Aug 2009 (estimated)
Results: Posted 29 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
36 mm	Active comparator	Device: 36 mm ceramic head on a ceramic acetabular liner36 mm ceramic head on ceramic acetabular liner
28 mm ceramic-on-polyethylene	Other	Device: 28 mm ceramic head on a polyethylene acetabular liner28 mm ceramic-on-polyethylene historical control

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 (21 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
36 mm ceramic head on a ceramic acetabular linerAlso: Delta Ceramax head on a ceramic liner.Total hip replacement with a 36 mm ceramic head on a ceramic liner	Device	36 mm
28 mm ceramic head on a polyethylene acetabular linerAlso: Delta Ceramax head on a polyethylene linerTotal hip replacement with a 28 mm ceramic head on a polyethylene liner.	Device	28 mm ceramic-on-polyethylene

Primary outcome

Total Harris Hip Score
Time frame: At final follow-up visit, 24 months or later, up to 72 months
The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. 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. The Total Harris Hip Score is a sum of its subscores (Pain, Function, Activities, Deformity, and Range of Motion).

7 secondary outcomes

Harris Hip Subscale Score: Pain
Time frame: At final follow-up visit, 24 months or later, up to 72 months
Harris Hip Subscale Score: Function
Time frame: At final follow-up visit, 24 months or later, up to 72 months
Harris Hip Subscale Score: Activities
Time frame: At final follow-up visit, 24 months or later, up to 72 months
Harris Hip Subscale Score: Deformity
Time frame: At final follow-up visit, 24 months or later, up to 72 months
Harris Hip Subscale Score: Range of Motion
Time frame: At final follow-up visit, 24 months or later, up to 72 months
Harris Hip Score Longitudinal Analysis
Time frame: 6 week, 6 month, 12 month, 24 month, 36 month, and 48 months post-operatively
Proportion of Composite Successes
Time frame: At final follow-up visit, 24 months or later, up to 72 months

Results and safety

Results posted to the registry on 29 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
36 mm Ceramic-on-ceramic	169	150
28 mm Ceramic-on-polyethylene	74	69

Primary outcome: Total Harris Hip Score

Time frame: At final follow-up visit, 24 months or later, up to 72 months. Least squares mean (Standard Deviation). Unit: units on a scale

Measure	36 mm Ceramic-on-ceramic n = 148	28 mm Ceramic-on-polyethylene n = 69
Value	95.6 (8.8)	94.9 (8.9)

36 mm Ceramic-on-ceramic vs 28 mm Ceramic-on-polyethylene: Mean Difference (Final Values): 0.7, p <0.001, ANCOVA

Population analysed: The population for this primary endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Intra-operatively through last follow-up, which was up to 72 months post-op for some subjects.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
36 mm Ceramic-on-ceramic	0 of 169 (0%)	134 of 169 (79.3%)	Not reported
28 mm Ceramic-on-polyethylene	0 of 74 (0%)	60 of 74 (81.1%)	Not reported

Limitations and caveats (from the sponsor): At study inception, information on whether or not an adverse event was deemed to be serious was not collected. Because of this caveat, the Sponsor has reported all adverse events that occurred in this study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Non-inflammatory Degenerative Joint Disease

RecruitingObservational study
Tornier Perform™ Reversed Monopost Study
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Active, not recruitingObservational study
PMCF Study on the Safety and Performance of the Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty
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RecruitingObservational study
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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

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 21 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 10 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 5 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 29 Aug 2014). 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?

Total Harris Hip Score (time frame: At final follow-up visit, 24 months or later, up to 72 months). 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 NCT00953719.

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 10 Apr 2019.