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

Not Applicable

Completed

Conditions: Avascular Necrosis
Post-Traumatic Osteoarthritis of Hip
Non-inflammatory Degenerative Joint Disease
Osteoarthritis

Interventions: Device: COC 36mm

Registration Number: NCT02096211

Lead Sponsor: DePuy Orthopaedics

Brief 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 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 172

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CERAMAX COC 36mm Acetabular Cup	COC 36mm	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.

Primary Outcome Measures

Name	Time	Method
Post-Operative 5-Year Device Survivorship	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 Outcome Measures

Name	Time	Method
Femoral Stem Tilt	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
Femoral Stem Subsidence	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.
Femoral Stem Heterotopic Ossification	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.
Femoral Radiolucent Lines	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
Femoral Osteolysis	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.
Femoral Stem Sclerotic Lines	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.
Femoral Stem Calcar Resorption	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
Femoral Stem Calcar Fracture	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
Kaplan Meier Device Survivorship at Years 1 Through 6	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.
Annual Total Harris Hip Score	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
Annual Harris Hip Pain Sub Score	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)
Annual Harris Hip Function and Activity Score	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)
Acetabular Cup Version - Annual Measurements	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.
Acetabular Cup Inclination	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
Acetabular Cup Migration	Measured from x-rays taken annually, years 1 through 5	Acetabular migration is the superior migration of the implant within the pelvic bone
Heterotopic Ossification	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
Acetabular Radiolucent Lines	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.
Acetabular Osteolysis	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.
Acetabular Sclerotic Lines	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.
Femoral Stem Position	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.

Trial Locations

Locations (13): TUFTS - New England Medical Center
🇺🇸
Boston, Massachusetts, United States
New England Baptist Hospital
🇺🇸
Boston, Massachusetts, United States
UPenn
🇺🇸
Philadelphia, Pennsylvania, United States
Orthopedic One
🇺🇸
Columbus, Ohio, United States
QEII Health Sciences Centre
🇨🇦
Halifax, Nova Scotia, Canada
London Health Sciences Centre - University Hospital
🇨🇦
London, Ontario, Canada
McGill University - Jewish General Hospital
🇨🇦
Montreal, Quebec, Canada
Queens University - Kingston General Hospital
🇨🇦
Kingston, Quebec, Canada
Joint Surgeons of Sacremento
🇺🇸
Sacramento, California, United States
Colorado Joint Replacement
🇺🇸
Denver, Colorado, United States
Florida Orthopaedic Institute
🇺🇸
Tampa, Florida, United States
Arthroplasty Foundation
🇺🇸
Louisville, Kentucky, United States
Samuel Wellman, MD / Duke University Medical Center
🇺🇸
Durham, North Carolina, United States