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Completed

NCT Number: NCT02096211

Ceramic-on-Ceramic (COC) 36mm Acetabular Bearing Insert Post Approval Study-New Subjects (COC36mmPAS)

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.

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Key information

Conditions

Non-inflammatory Degenerative Joint Disease Arthritis Avascular Necrosis Bone Diseases Joint Diseases Musculoskeletal Diseases Necrosis Osteoarthritis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Traumatic Osteoarthritis of Hip Rheumatic Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

QEII Health Sciences Centre, Halifax, Nova Scotia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)
  • 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.

Treatment and study plan

COC 36mm

Device

Total Hip Replacement with COC 36mm Acetabular Cup System

Other names: CERAMAX, CERAMAX 36mm, CERAMAX Acetabular System, 36mm CERAMAX Acetabular System

Primary outcomes

  1. 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.

Secondary outcomes

  1. Kaplan Meier Device Survivorship at Years 1 Through 6

    Time frame: Years 1 through 6 post-operatively

    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.

  2. Annual Total Harris Hip Score

    Time frame: Annually through 5 years

    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

  3. Annual Harris Hip Pain Sub Score

    Time frame: Annually through 5 years

    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)

  4. Annual Harris Hip Function and Activity Score

    Time frame: Annually through 5 years

    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)

  5. Acetabular Cup Version - Annual Measurements

    Time frame: Measured from x-rays taken annually, years 1 through 5

    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.

  6. Acetabular Cup Inclination

    Time frame: Measured from x-rays taken annually, years 1 through 5

    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

  7. Acetabular Cup Migration

    Time frame: Measured from x-rays taken annually, years 1 through 5

    Acetabular migration is the superior migration of the implant within the pelvic bone

  8. Heterotopic Ossification

    Time frame: Measured from x-rays taken annually, years 1 through 5

    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

  9. Acetabular Radiolucent Lines

    Time frame: Measured from x-rays taken annually, years 1 through 5

    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.

  10. Acetabular Osteolysis

    Time frame: Measured from x-rays taken annually, years 1 through 5

    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.

  11. Acetabular Sclerotic Lines

    Time frame: Measured from x-rays taken annually, years 1 though 5

    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.

  12. Femoral Stem Position

    Time frame: Measured from x-rays taken annually, years 1 through 5

    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.

  13. Femoral Stem Tilt

    Time frame: Measured from x-rays taken annually, years 1 through 5

    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

  14. Femoral Stem Subsidence

    Time frame: Measured from x-rays taken annually, years 1 through 5

    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.

  15. Femoral Stem Heterotopic Ossification

    Time frame: Measured from x-rays taken annually, years 1 through 5

    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.

  16. Femoral Radiolucent Lines

    Time frame: Measured from x-rays taken annually, years 1 through 5

    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

  17. Femoral Osteolysis

    Time frame: Measured from x-rays taken annually, years 1 through 5

    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.

  18. Femoral Stem Sclerotic Lines

    Time frame: Measured from x-rays taken annually, years 1 through 5

    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.

  19. Femoral Stem Calcar Resorption

    Time frame: Measure from x-rays taken annually, years 1 through 5

    Femoral calcar resorption occurs when the bone around the prosthesis is partially shielded from bearing loads and begins to resorb

  20. Femoral Stem Calcar Fracture

    Time frame: Measured from x-rays taken annually, years 1 through 5

    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

Sponsors and collaborators

Lead sponsor

DePuy Orthopaedics

Industry

Registry information

Official study 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)

Acronym: COC36mmPAS

Important dates

Study start
2014
Primary completion
2023
Study completion
2023
First posted
Mar 26, 2014
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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