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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
172
Total Hip Replacement with COC 36mm Acetabular Cup System
Joint Surgeons of Sacremento
Sacramento, California, United States
Colorado Joint Replacement
Denver, Colorado, United States
Florida Orthopaedic Institute
Tampa, Florida, United States
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.
Time frame: 5 years
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.
Time frame: 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
Time frame: 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)
Time frame: 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)
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Arthroplasty Foundation
Louisville, Kentucky, United States
TUFTS - New England Medical Center
Boston, Massachusetts, United States
New England Baptist Hospital
Boston, Massachusetts, United States
Samuel Wellman, MD / Duke University Medical Center
Durham, North Carolina, United States
Orthopedic One
Columbus, Ohio, United States
UPenn
Philadelphia, Pennsylvania, United States
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
...and 3 more locations
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Measured from x-rays taken annually, years 1 through 5