Non-inflammatory Degenerative Joint DiseaseCOC36mmPASNCT02096211
Ceramic-on-Ceramic (COC) 36mm Acetabular Bearing Insert Post Approval Study-New Subjects (COC36mmPAS)
A study testing COC 36mm in people with Non-inflammatory Degenerative Joint Disease and Osteoarthritis, run by DePuy Orthopaedics at 13 sites in 2 countries.
Trial summary
This study is intended to gather short (Pre-operative to 4-years) and mid-term (5-years) information regarding the performance and safety of the commercially available 36mm CERAMAX® Ceramic on Ceramic Total Hip System from a cohort of new study subjects that were not previously involved in the IDE study for this… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Avascular Necrosis
- What is being tested?
- COC 36mm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 1 Jun 2014to 31 Dec 2023
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females between 21 - 75 at the time of surgery.
- Individuals, who in the opinion of the investigator, are suitable candidates for primary total hip replacement using the devices specified in this protocol.
- Individuals with non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, and posttraumatic arthritis.
- Individuals who are willing and able to provide informed patient consent for participation in the study;
- Individuals who are willing and able to return for follow-up as specified by the study protocol; and
- Individuals who are willing and able to complete the Subject Hip Outcomes questionnaire as specified by the study protocol.
Who cannot join
- Skeletally immature patients (tibial and femoral epiphyses 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 any known neoplastic (tumor-causing) or metastatic (spread of cancerous cells) disease
- Significant neurologic or musculoskeletal disorders or diseases that may adversely affect gait, weight bearing or postoperative recovery (e.g., muscular dystrophy, multiple sclerosis)
- Presence of highly communicable disease(s) that may limit follow-up (e.g., immuno-compromised conditions, hepatitis, active tuberculosis, etc.)
- Any condition that may interfere with postoperative recovery (e.g., Paget's disease, Charcot's disease)
Show all 16Show fewer
- Inadequate bone stock to support the device (e.g., severe osteopenia orosteoporosis)
- Poor skin coverage around the hip joint
- Use in patients with known allergies to the implant materials
- Marked atrophy (muscle and/or tissue loss) or deformity in the upper femur such as a birth defect affecting the leg bones.
- Inflammatory degenerative joint disease (like rheumatoid arthritis)
- Subject has participated in an IDE/IND clinical investigation, other than the COC28/COC36 IDE or PAS for their contralateral hip, with an investigational product in the last three months.
- Subject is currently involved in a personal injury litigation, medical-legal or worker's compensation claims.
- Subject is a known drug or alcohol abuser or has a psychological disorder that could affect their ability to comply with protocol procedures and/or subject-completed questionnaires.
- The Subject is a woman who is pregnant or lactating.
- The Subject has a medical condition with less than 2 years of life expectancy.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States9 sites
TUFTS - New England Medical Center
Boston, Massachusetts, 02111
New England Baptist Hospital
Boston, Massachusetts, 02120
Orthopedic One
Columbus, Ohio, 43213
Colorado Joint Replacement
Denver, Colorado
Samuel Wellman, MD / Duke University Medical Center
Durham, North Carolina, 27705
Arthroplasty Foundation
Louisville, Kentucky
UPenn
Philadelphia, Pennsylvania, 19104
Joint Surgeons of Sacremento
Sacramento, California
Florida Orthopaedic Institute
Tampa, Florida
Canada4 sites
QEII Health Sciences Centre
Halifax, Nova Scotia
Queens University - Kingston General Hospital
Kingston, Quebec
London Health Sciences Centre - University Hospital
London, Ontario
McGill University - Jewish General Hospital
Montreal, Quebec, H3T 1E2
About this study
Official title: 36mm CERAMAX® Ceramic Hip System PMA PAS STUDY: Short to Mid-Term Follow-up , New Study Subjects (Ceramic Hip System, Subjects Receive CERAMAX 36mm Ceramic Acetabular Bearing Insert That Articulates With a Ceramic Femoral Head for THA)
This study is intended to gather short (Pre-operative to 4-years) and mid-term (5-years) information regarding the performance and safety of the commercially available 36mm CERAMAX® Ceramic on Ceramic Total Hip System from a cohort of new study subjects that were not previously involved in the IDE study for this device.
Read the detailed description
Up to 10 (up to 5 original IDE + 5 new sites)
A prospective, non-controlled, non-randomized, multicenter study. Subjects will be seen for a clinic visit pre-operatively at the time of consent, (-90 days to surgery) and then at post-operatively at 6 weeks (1-92 days), 1 year (275-455 days), 2 years (640-820 days) and 3 years (1005-1185days), 4 years (1370-1550 days), and a minimum of 5 years (1825- 2555 days).
Data collected will include: Pre-operatively subject history and demographics; Operative and device details; and Post-operatively Harris HIp scores, Subject Hip Outcomes, and Adverse Events.
In order to optimize mid-term follow-up compliance, site personnel are permitted to contact the study subject in the 3 and 4 year intervals by phone (in place of a clinic visit) to assess the current status of the hip.
- Conditions
- Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Avascular Necrosis, Post-Traumatic Osteoarthritis of Hip
- Being tested
- COC 36mm
- Keywords
- Total hip replacement, Total hip arthroplasty, Hip joint replacement, Hip prosthesis replacement
- Medical subject headings
- Osteoarthritis, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COC 36mmDevice
Also called CERAMAX, CERAMAX 36mm, CERAMAX Acetabular System, 36mm CERAMAX Acetabular System
Total Hip Replacement with COC 36mm Acetabular Cup System
| Study group | Role | What they receive |
|---|---|---|
| CERAMAX COC 36mm Acetabular Cup | Other | The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper. Receives: Device: COC 36mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Operative 5-Year Device Survivorship
Device survivorship at 5 years post-operatively was the primary endpoint in this study. A revision is defined as the removal of any Total Hip Arthroplasty (THA) component(s), and device survival is defined as the lack of revision. A 5-year Kaplan-Meier survivorship estimate of COC 36 mm implanted hips is provided.
Measured: 5 years
Secondary outcomes (20)
Kaplan Meier Device Survivorship at Years 1 Through 6
Device survivorship at each year post-operative was a secondary endpoint in this study. A revision is defined as the removal of any Total Hip Arthroplasty (THA) component(s), and device survival is defined as the lack of revision. A Kaplan-Meier survivorship estimate of COC 36 mm implanted hips is provided for each post-operative year.
Measured: Years 1 through 6 post-operatively
Annual Total Harris Hip Score
The Harris Hip Score (HHS) is a standardized tool used to evaluate hip pain, function, and mobility. The HHS is score from 0 to 100, with higher scores indicating better outcomes. A score of less than 70 is considered poor, 70-80 is fair, 80-90 is good, 90-100 is excellent
Measured: Annually through 5 years
Annual Harris Hip Pain Sub Score
The Harris Hip Score (HHS) is a standardized tool used to evaluate hip pain, function, and mobility. The HHS is score from 0 to 100, with higher scores indicating better outcomes. A score of less than 70 is considered poor, 70-80 is fair, 80-90 is good, 90-100 is excellent
This Secondary Outcome reports on the Pain Sub Score which has categories of None (44 points), Slight (40), Mild (30), Moderate (20), Marked (10), and Totally Disabled (0)
Measured: Annually through 5 years
Annual Harris Hip Function and Activity Score
The Harris Hip Score (HHS) is a standardized tool used to evaluate hip pain, function, and mobility. The HHS is score from 0 to 100, with higher scores indicating better outcomes. A score of less than 70 is considered poor, 70-80 is fair, 80-90 is good, 90-100 is excellent
This Secondary Outcome reports on the Function and Activity Sub Score which has categories of Normal (40-47 points), Mild Dysfunction (30-39), Moderate Dysfunction (20-29), Severe Dysfunction (10-19), and Disabled (0 - 9)
Measured: Annually through 5 years
Acetabular Cup Version - Annual Measurements
Acetabular cup version is the angle formed between the axis of the implant and the coronal plane of the body. Acetabular version typically ranges between 11.5 and 28.5 degrees.
Measured: Measured from x-rays taken annually, years 1 through 5
Acetabular Cup Inclination
Acetabular cup inclination is the angle between the longitudinal axis of the patient and a perpendicular line to the major axis of the cup projection. The target acetabular cup inclination is between 30-50 degrees
Measured: Measured from x-rays taken annually, years 1 through 5
Acetabular Cup Migration
Acetabular migration is the superior migration of the implant within the pelvic bone
Measured: Measured from x-rays taken annually, years 1 through 5
Heterotopic Ossification
Heterotopic ossification is the abnormal formation of bone in soft tissues, such as muscles, tendons, or ligaments and can occur around the hip joint, leading to pain, stiffness, and restricted range of motion. It is graded as Class 0 through Class IV, with Class 0 being least impactful and Class IV being most impactful
Measured: Measured from x-rays taken annually, years 1 through 5
Acetabular Radiolucent Lines
Radiolucent lines are seen on x-rays and represent an area that is absent of bone. Radiolucent lines seen adjacent to an implant may suggest a lack on bone ingrowth or possible loosening of the implant.
Radiolucent lines greater than 1mm wide were considered reportable for this study.
Measured: Measured from x-rays taken annually, years 1 through 5
Acetabular Osteolysis
Osteolysis is seen on x-rays and represent an area where bone has been resorbed by the body in response to small particles of debris that are created as an implant wears over time. Osteolysis greater than 5mm was considered to be reportable for this study.
Measured: Measured from x-rays taken annually, years 1 through 5
Acetabular Sclerotic Lines
Acetabular sclerotic lines are seen on x-rays and are radio-dense areas of bone that have remodeled due to loads close to the implant.
Measured: Measured from x-rays taken annually, years 1 though 5
Femoral Stem Position
Femoral stem position is categorized as neutral, valgus, or varus. A neutral stem is centered within the femoral canal that runs through the center of the femur's long axis. A valgus femoral stem is positioned slightly towards the medial side of the femoral canal, and a varus femoral stem is positioned slightly towards the lateral side of the femoral canal.
Measured: Measured from x-rays taken annually, years 1 through 5
Femoral Stem Tilt
Femoral stem tilt is a measurement taken at each post-operative year and compared against baseline images collected at 6-weeks post-operative. The measurement captures changes in the position of the femoral stem over time. Tilt greater than 2 degrees was considered reportable for this study
Measured: Measured from x-rays taken annually, years 1 through 5
Femoral Stem Subsidence
Femoral stem subsidence is the inferior movement of the stem within the femoral canal. Subsidence greater than 2 mm was considered reportable for this study.
Measured: Measured from x-rays taken annually, years 1 through 5
Femoral Stem Heterotopic Ossification
Heterotopic ossification is the abnormal formation of bone in soft tissues such as muscles, tendons, or ligaments and can occur around the hip joint, leading to pain, stiffness, and restricted range of motion. It is graded as Class 0 through Class IV, with Class O having no bone growth in soft tissue, Class I being least impactful and Class IV being most impactful.
Measured: Measured from x-rays taken annually, years 1 through 5
Femoral Radiolucent Lines
Radiolucencies are seen on x-rays and represent an area that is absent of bone. Radiolucent lines seen adjacent to an implant may suggest a lack of bone ingrowth into the implant or possible loosening of the implant
Measured: Measured from x-rays taken annually, years 1 through 5
Femoral Osteolysis
Osteolysis is seen on x-rays and represent an area where bone has been resorbed by the body in response to small particles of debris that are created as an implant wears over time. Osteolysis greater than 5mm was considered to be reportable for this study.
Measured: Measured from x-rays taken annually, years 1 through 5
Femoral Stem Sclerotic Lines
Acetabular sclerotic lines are seen on x-rays and are radio-dense areas of bone that have remodeled due to loads close to the implant.
Measured: Measured from x-rays taken annually, years 1 through 5
Femoral Stem Calcar Resorption
Femoral calcar resorption occurs when the bone around the prosthesis is partially shielded from bearing loads and begins to resorb
Measured: Measure from x-rays taken annually, years 1 through 5
Femoral Stem Calcar Fracture
Near the top of the femur is a region of bone called the calcar femorale that provides strength to the femur when compressive forces are applied. During preparation of the femur to receive the femoral implant there is the possibility of fractures occurring in this region
Measured: Measured from x-rays taken annually, years 1 through 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study start1 Jun 2014
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Terrence D Whalen, BS, DC, Study director, DePuy Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096211
- Sponsor's protocol ID
- 12017
- Acronym
- COC36mmPAS
- Status last verified
- Jul 2025
- First submitted
- 21 Mar 2014
- Last updated
- 16 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 36mm CERAMAX® Ceramic Hip System PMA PAS STUDY: Short to Mid-Term Follow-up , New Study Subjects (Ceramic Hip System, Subjects Receive CERAMAX 36mm Ceramic Acetabular Bearing Insert That Articulates With a Ceramic Femoral Head for THA)
- ClinicalTrials.gov ID
- NCT02096211
- Acronym / sponsor ID
- COC36mmPAS / 12017
- Conditions
- Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Avascular Necrosis, Post-Traumatic Osteoarthritis of Hip
- Keywords
- Total hip replacement, Total hip arthroplasty, Hip joint replacement, Hip prosthesis replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Posted 6 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is intended to gather short (Pre-operative to 4-years) and mid-term (5-years) information regarding the performance and safety of the commercially available 36mm CERAMAX® Ceramic on Ceramic Total Hip System from a cohort of new study subjects that were not previously involved in the IDE study for this device.
Detailed description
Up to 10 (up to 5 original IDE + 5 new sites)
A prospective, non-controlled, non-randomized, multicenter study. Subjects will be seen for a clinic visit pre-operatively at the time of consent, (-90 days to surgery) and then at post-operatively at 6 weeks (1-92 days), 1 year (275-455 days), 2 years (640-820 days) and 3 years (1005-1185days), 4 years (1370-1550 days), and a minimum of 5 years (1825- 2555 days).
Data collected will include: Pre-operatively subject history and demographics; Operative and device details; and Post-operatively Harris HIp scores, Subject Hip Outcomes, and Adverse Events.
In order to optimize mid-term follow-up compliance, site personnel are permitted to contact the study subject in the 3 and 4 year intervals by phone (in place of a clinic visit) to assess the current status of the hip.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CERAMAX COC 36mm Acetabular Cup | Other | Device: COC 36mmThe CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females between 21 - 75 at the time of surgery.
- Individuals, who in the opinion of the investigator, are suitable candidates for primary total hip replacement using the devices specified in this protocol.
- Individuals with non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, and posttraumatic arthritis.
- Individuals who are willing and able to provide informed patient consent for participation in the study;
- Individuals who are willing and able to return for follow-up as specified by the study protocol; and
Key exclusion criteria (16 listed)
- Skeletally immature patients (tibial and femoral epiphyses 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 any known neoplastic (tumor-causing) or metastatic (spread of cancerous cells) disease
- Significant neurologic or musculoskeletal disorders or diseases that may adversely affect gait, weight bearing or postoperative recovery (e.g., muscular dystrophy, multiple sclerosis)
- Presence of highly communicable disease(s) that may limit follow-up (e.g., immuno-compromised conditions, hepatitis, active tuberculosis, etc.)
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 |
|---|---|---|
| COC 36mmAlso: CERAMAX, CERAMAX 36mm, CERAMAX Acetabular System, 36mm CERAMAX Acetabular SystemTotal Hip Replacement with COC 36mm Acetabular Cup System | Device | CERAMAX COC 36mm Acetabular Cup |
Primary outcome
Post-Operative 5-Year Device Survivorship
Time frame: 5 years
Device survivorship at 5 years post-operatively was the primary endpoint in this study. A revision is defined as the removal of any Total Hip Arthroplasty (THA) component(s), and device survival is defined as the lack of revision. A 5-year Kaplan-Meier survivorship estimate of COC 36 mm implanted hips is provided.
20 secondary outcomes
Kaplan Meier Device Survivorship at Years 1 Through 6
Time frame: Years 1 through 6 post-operatively
Annual Total Harris Hip Score
Time frame: Annually through 5 years
Annual Harris Hip Pain Sub Score
Time frame: Annually through 5 years
Annual Harris Hip Function and Activity Score
Time frame: Annually through 5 years
Acetabular Cup Version - Annual Measurements
Time frame: Measured from x-rays taken annually, years 1 through 5
Acetabular Cup Inclination
Time frame: Measured from x-rays taken annually, years 1 through 5
Acetabular Cup Migration
Time frame: Measured from x-rays taken annually, years 1 through 5
Heterotopic Ossification
Time frame: Measured from x-rays taken annually, years 1 through 5
Acetabular Radiolucent Lines
Time frame: Measured from x-rays taken annually, years 1 through 5
Acetabular Osteolysis
Time frame: Measured from x-rays taken annually, years 1 through 5
Acetabular Sclerotic Lines
Time frame: Measured from x-rays taken annually, years 1 though 5
Femoral Stem Position
Time frame: Measured from x-rays taken annually, years 1 through 5
Femoral Stem Tilt
Time frame: Measured from x-rays taken annually, years 1 through 5
Femoral Stem Subsidence
Time frame: Measured from x-rays taken annually, years 1 through 5
Femoral Stem Heterotopic Ossification
Time frame: Measured from x-rays taken annually, years 1 through 5
Femoral Radiolucent Lines
Time frame: Measured from x-rays taken annually, years 1 through 5
Femoral Osteolysis
Time frame: Measured from x-rays taken annually, years 1 through 5
Femoral Stem Sclerotic Lines
Time frame: Measured from x-rays taken annually, years 1 through 5
Femoral Stem Calcar Resorption
Time frame: Measure from x-rays taken annually, years 1 through 5
Femoral Stem Calcar Fracture
Time frame: Measured from x-rays taken annually, years 1 through 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- 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.
Terrence D Whalen, BS, DC study director
DePuy Orthopaedics
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COC 36mm in people with Non-inflammatory Degenerative Joint Disease and Osteoarthritis, run by DePuy Orthopaedics at 13 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 6 inclusion and 16 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 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 6 May 2025). 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?
Post-Operative 5-Year Device Survivorship (time frame: 5 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 16 Jul 2025.