Avascular Necrosis, Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Post-Traumatic Osteoarthritis of Hip
Conditions
Keywords
Total hip replacement, Total hip arthroplasty, Hip joint replacement, Hip prosthesis replacement
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.
Interventions
DEVICECOC 36mm
Total Hip Replacement with COC 36mm Acetabular Cup System
Sponsors
DePuy Orthopaedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
| 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) |
| 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. |
| 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 |
| 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. |
Countries
Canada, United States
Participant flow
Recruitment details
All eligible patients were asked if they were interested in study participation
Participants by arm
| Arm | Count |
|---|---|
| CERAMAX COC 36mm Acetabular Cup 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. | 170 |
| Total | 170 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Lost to Follow-up | 43 |
| Overall Study | Revision of implant | 7 |
| Overall Study | Withdrawal by Subject | 8 |
Baseline characteristics
| Characteristic | CERAMAX COC 36mm Acetabular Cup |
|---|---|
| Age, Continuous Participant Age | 53.6 Years STANDARD_DEVIATION 10.65 |
| Ethnicity (NIH/OMB) Study Participant Ethnicity Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Study Participant Ethnicity Not Hispanic or Latino | 168 Participants |
| Ethnicity (NIH/OMB) Study Participant Ethnicity Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Study Participant Race American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Study Participant Race Asian | 0 Participants |
| Race (NIH/OMB) Study Participant Race Black or African American | 26 Participants |
| Race (NIH/OMB) Study Participant Race More than one race | 0 Participants |
| Race (NIH/OMB) Study Participant Race Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Study Participant Race Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Study Participant Race White | 143 Participants |
| Sex: Female, Male Female | 70 Participants |
| Sex: Female, Male Male | 100 Participants |
| Study Participant Primary Diagnosis Avascular Necrosis | 22 Participants |
| Study Participant Primary Diagnosis Osteoarthritis | 144 Participants |
| Study Participant Primary Diagnosis Post Traumatic Arthritis | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 170 |
| other Total, other adverse events | 141 / 170 |
| serious Total, serious adverse events | 86 / 170 |
Outcome results
Primary
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
Population: All Study Participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CERAMAX COC 36mm Acetabular Cup | Post-Operative 5-Year Device Survivorship | 95.3 Percentage of implants |
Secondary
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
Population: All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CERAMAX COC 36mm Acetabular Cup | Acetabular Cup Inclination | Acetabular cup inclination, measured at 1 year | 42.9 Degrees | Standard Deviation 8.76 |
| CERAMAX COC 36mm Acetabular Cup | Acetabular Cup Inclination | Acetabular cup inclination, measured at 2 years | 42.2 Degrees | Standard Deviation 8.19 |
| CERAMAX COC 36mm Acetabular Cup | Acetabular Cup Inclination | Acetabular cup inclination, measured at 3 years | 42.6 Degrees | Standard Deviation 7.62 |
| CERAMAX COC 36mm Acetabular Cup | Acetabular Cup Inclination | Acetabular cup inclination, measured at 4 years | 43 Degrees | Standard Deviation 8.44 |
| CERAMAX COC 36mm Acetabular Cup | Acetabular Cup Inclination | Acetabular cup inclination, measured at 5 years | 43.5 Degrees | Standard Deviation 8.05 |
Secondary
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
Population: All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| CERAMAX COC 36mm Acetabular Cup | Acetabular Cup Migration | Number of Participants with acetabular cup migration at 1 year | 0 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Acetabular Cup Migration | Number of Participants with acetabular cup migration at 2 years | 0 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Acetabular Cup Migration | Number of Participants with acetabular cup migration at 3 years | 0 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Acetabular Cup Migration | Number of Participants with acetabular cup migration at 4 years | 0 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Acetabular Cup Migration | Number of Participants with acetabular cup migration at 5 years | 0 Participant Hips |
Secondary
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
Population: All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CERAMAX COC 36mm Acetabular Cup | Acetabular Cup Version - Annual Measurements | Acetabular cup version degrees, measured at 1 year | 22.8 Degrees | Standard Deviation 8.73 |
| CERAMAX COC 36mm Acetabular Cup | Acetabular Cup Version - Annual Measurements | Acetabular cup version degrees, measured at 2 years | 23.7 Degrees | Standard Deviation 7.51 |
| CERAMAX COC 36mm Acetabular Cup | Acetabular Cup Version - Annual Measurements | Acetabular cup version degrees, measured at 3 years | 25.1 Degrees | Standard Deviation 5.56 |
| CERAMAX COC 36mm Acetabular Cup | Acetabular Cup Version - Annual Measurements | Acetabular cup version degrees, measured at 4 years | 23.8 Degrees | Standard Deviation 6.42 |
| CERAMAX COC 36mm Acetabular Cup | Acetabular Cup Version - Annual Measurements | Acetabular cup version degrees, measured at 5 years | 26.1 Degrees | Standard Deviation 5.13 |
Secondary
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
Population: All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| CERAMAX COC 36mm Acetabular Cup | Acetabular Osteolysis | Number of study Participants with acetabular osteolysis at 1 year | 2 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Acetabular Osteolysis | Number of study Participants with acetabular osteolysis at 2 years | 2 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Acetabular Osteolysis | Number of study Participants with acetabular osteolysis at 3 years | 0 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Acetabular Osteolysis | Number of study Participants with acetabular osteolysis at 4 years | 0 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Acetabular Osteolysis | Number of study Participants with acetabular osteolysis at 5 years | 1 Participant hips |
Secondary
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
Population: All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| CERAMAX COC 36mm Acetabular Cup | Acetabular Radiolucent Lines | Number of study Participants with radiolucent lines greater than 1mm in width at 1 year | 1 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Acetabular Radiolucent Lines | Number of study Participants with radiolucent lines greater than 1mm in width at 2 years | 1 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Acetabular Radiolucent Lines | Number of study Participants with radiolucent lines greater than 1mm in width at 3 years | 1 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Acetabular Radiolucent Lines | Number of study Participants with radiolucent lines greater than 1mm in width at 4 years | 1 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Acetabular Radiolucent Lines | Number of study Participants with radiolucent lines greater than 1mm in width at 5 years | 1 Participant hips |
Secondary
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
Population: All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| CERAMAX COC 36mm Acetabular Cup | Acetabular Sclerotic Lines | Number of study Participants with acetabular sclerotic lines present at 4 Years | 3 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Acetabular Sclerotic Lines | Number of study Participants with acetabular sclerotic lines present at 5 Years | 3 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Acetabular Sclerotic Lines | Number of study Participants with acetabular sclerotic lines present at 1 Year | 1 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Acetabular Sclerotic Lines | Number of study Participants with acetabular sclerotic lines present at 2 Years | 3 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Acetabular Sclerotic Lines | Number of study Participants with acetabular sclerotic lines present at 3 Years | 3 Participant Hips |
Secondary
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)
Time frame: Annually through 5 years
Population: All Study Participants who attended their annual clinical evaluation
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Function and Activity Score | Harris Hip Function and Activity Score at 1 Year Subjects with a Normal Score (40-47) | 96 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Function and Activity Score | Harris Hip Function and Activity Score at 1 Year Subjects with a Mild Dysfunction Score (30-39) | 28 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Function and Activity Score | Harris Hip Function and Activity Score at 1 Yr Subjects with a Moderate Dysfunction Score (20-29) | 3 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Function and Activity Score | Harris Hip Function and Activity Score at 1 Year Subjects with a Severe Dysfunction Score (10-19) | 1 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Function and Activity Score | Harris Hip Function and Activity Score at 1 Year Subjects with a Disabled Score (0-9) | 0 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Function and Activity Score | Harris Hip Function and Activity Score at 2 Years Subjects with a Normal Score (40-47) | 99 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Function and Activity Score | Harris Hip Function and Activity Score at 2 Years Subjects with a Mild Dysfunction Score (30-39) | 16 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Function and Activity Score | Harris Hip Function and Activity Score at 2 Yrs Subjects with a Moderate Dysfunction Score (20-29) | 7 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Function and Activity Score | Harris Hip Function and Activity Score at 2 Years Subjects with a Severe Dysfunction Score (10-19) | 1 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Function and Activity Score | Harris Hip Function and Activity Score at 2 Years Subjects with a Disabled Score (0-9) | 0 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Function and Activity Score | Harris Hip Function and Activity Score at 3 Years Subjects with a Normal Score (40-47) | 51 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Function and Activity Score | Harris Hip Function and Activity Score at 3 Years Subjects with a Mild Dysfunction Score (30-39) | 12 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Function and Activity Score | Harris Hip Function and Activity Score at 3 Yrs Subjects with a Moderate Dysfunction Score (20-29) | 3 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Function and Activity Score | Harris Hip Function and Activity Score at 3 Years Subjects with a Severe Dysfunction Score (10-19) | 1 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Function and Activity Score | Harris Hip Function and Activity Score at 3 Years Subjects with a Disabled Score (0-9) | 0 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Function and Activity Score | Harris Hip Function and Activity Score at 4 Years Subjects with a Normal Score (40-47) | 20 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Function and Activity Score | Harris Hip Function and Activity Score at 4 Years Subjects with a Mild Dysfunction Score (30-39) | 9 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Function and Activity Score | Harris Hip Function and Activity Score at 4 Yrs Subjects with a Moderate Dysfunction Score (20-29) | 5 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Function and Activity Score | Harris Hip Function and Activity Score at 4 Years Subjects with a Severe Dysfunction Score (10-19) | 0 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Function and Activity Score | Harris Hip Function and Activity Score at 4 Years Subjects with a Disabled Score (0-9) | 1 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Function and Activity Score | Harris Hip Function and Activity Score at 5 Years Subjects with a Normal Score (40-47) | 87 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Function and Activity Score | Harris Hip Function and Activity Score at 5 Years Subjects with a Mild Dysfunction Score (30-39) | 14 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Function and Activity Score | Harris Hip Function and Activity Score at 5 Yrs Subjects with a Moderate Dysfunction Score (20-29) | 6 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Function and Activity Score | Harris Hip Function and Activity Score at 5 Years Subjects with a Severe Dysfunction Score (10-19) | 2 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Function and Activity Score | Harris Hip Function and Activity Score at 5 Years Subjects with a Disabled Score (0-9) | 1 Participant Hips |
Secondary
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
Population: All study participants who attended their annual clinical evaluation
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 1 year Participants with a None Score (44) | 84 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 1 year Participants with a Moderate Score (20) | 6 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 3 years Participants with a None Score (44) | 51 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 1 year Participants with a Slight Score (40) | 28 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 1 year Participants with a Mild Score (30) | 7 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 2 years Participants with a Totally Disabled Score (0) | 1 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 1 year Participants with a Marked Score (10) | 2 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 1 year Participants with a Totally Disabled Score (0) | 1 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 2 years Participants with a None Score (44) | 87 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 2 years Participants with a Slight Score (40) | 18 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 2 years Participants with a Mild Score (30) | 11 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 2 years Participants with a Moderate Score (20) | 5 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 2 years Participants with a Marked Score (10) | 1 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 3 years Participants with a Slight Score (40) | 8 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 3 years Participants with a Mild Score (30) | 2 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 3 years Participants with a Moderate Score (20) | 2 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 3 years Participants with a Marked Score (10) | 1 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 3 years Participants with a Totally Disabled Score (0) | 0 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 4 years Participants with a None Score (44) | 23 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 4 years Participants with a Slight Score (40) | 6 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 4 years Participants with a Mild Score (30) | 2 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 4 years Participants with a Moderate Score (20) | 2 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 4 years Participants with a Marked Score (10) | 2 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 4 years Participants with a Totally Disabled Score (0) | 0 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 5 years Participants with a None Score (44) | 81 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 5 years Participants with a Slight Score (40) | 15 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 5 years Participants with a Mild Score (30) | 7 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 5 years Participants with a Moderate Score (20) | 7 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 5 years Participants with a Marked Score (10) | 0 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Harris Hip Pain Sub Score | Harris Hip Pain Sub Score at 5 years Participants with a Totally Disabled Score (0) | 0 Participant hips |
Secondary
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
Population: All study participants who attended their annual clinical evaluation
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| CERAMAX COC 36mm Acetabular Cup | Annual Total Harris Hip Score | Harris Hip score at 4 years. Number of participants with Poor Scores (Less than 70) | 3 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Total Harris Hip Score | Harris Hip score at 1 year Number of participants with Excellent Scores (90-100) | 98 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Total Harris Hip Score | Harris Hip score at 1 year Number of participants with Good Scores (80-89) | 18 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Total Harris Hip Score | Harris Hip score at 1 year Number of participants with Fair Scores (70-79) | 4 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Total Harris Hip Score | Harris Hip score at 1 year Number of participants with Poor Scores (Less than 70) | 8 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Total Harris Hip Score | Harris Hip score at 2 years. Number of participants with Excellent Scores (90-100) | 90 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Total Harris Hip Score | Harris Hip score at 2 years. Number of participants with Good Scores (80-89) | 20 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Total Harris Hip Score | Harris Hip score at 2 years. Number of participants with Fair Scores (70-79) | 6 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Total Harris Hip Score | Harris Hip score at 2 years. Number of participants with Poor Scores (Less than 70) | 7 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Total Harris Hip Score | Harris Hip score at 3 years. Number of participants with Excellent Scores (90-100) | 50 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Total Harris Hip Score | Harris Hip score at 3 years. Number of participants with Good Scores (80-89) | 5 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Total Harris Hip Score | Harris Hip score at 3 years. Number of participants with Fair Scores (70-79) | 2 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Total Harris Hip Score | Harris Hip score at 3 years. Number of participants with Poor Scores (Less than 70) | 6 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Total Harris Hip Score | Harris Hip score at 4 years. Number of participants with Excellent Scores (90-100) | 20 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Total Harris Hip Score | Harris Hip score at 4 years. Number of participants with Good Scores (80-89) | 7 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Total Harris Hip Score | Harris Hip score at 4 years. Number of participants with Fair Scores (70-79) | 1 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Total Harris Hip Score | Harris Hip score at 5 years. Number of participants with Excellent Scores (90-100) | 85 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Total Harris Hip Score | Harris Hip score at 5 years. Number of participants with Good Scores (80-89) | 11 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Total Harris Hip Score | Harris Hip score at 5 years. Number of participants with Fair Scores (70-79) | 8 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Annual Total Harris Hip Score | Harris Hip score at 5 years. Number of participants with Poor Scores (Less than 70) | 5 Participant hips |
Secondary
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
Population: All study Participants who returned for scheduled follow-up clinic visits and had radiographic images taken
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CERAMAX COC 36mm Acetabular Cup | Femoral Osteolysis | Number of study Participants with femoral osteolysis at 1 year | 0 Participants |
| CERAMAX COC 36mm Acetabular Cup | Femoral Osteolysis | Number of study Participants with femoral osteolysis at 2 years | 0 Participants |
| CERAMAX COC 36mm Acetabular Cup | Femoral Osteolysis | Number of study Participants with femoral osteolysis at 3 years | 0 Participants |
| CERAMAX COC 36mm Acetabular Cup | Femoral Osteolysis | Number of study Participants with femoral osteolysis at 4 years | 0 Participants |
| CERAMAX COC 36mm Acetabular Cup | Femoral Osteolysis | Number of study Participants with femoral osteolysis at 5 years | 0 Participants |
Secondary
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
Population: All study Participants who returned for scheduled follow-up clinic visits and had radiographic images taken
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CERAMAX COC 36mm Acetabular Cup | Femoral Radiolucent Lines | Study Participants with femoral radiolucent lines present at 1 year | 0 Participants |
| CERAMAX COC 36mm Acetabular Cup | Femoral Radiolucent Lines | Study Participants with femoral radiolucent lines present at 2 years | 1 Participants |
| CERAMAX COC 36mm Acetabular Cup | Femoral Radiolucent Lines | Study Participants with femoral radiolucent lines present at 3 years | 0 Participants |
| CERAMAX COC 36mm Acetabular Cup | Femoral Radiolucent Lines | Study Participants with femoral radiolucent lines present at 4 years | 0 Participants |
| CERAMAX COC 36mm Acetabular Cup | Femoral Radiolucent Lines | Study Participants with femoral radiolucent lines present at 5 years | 0 Participants |
Secondary
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
Population: All study Participants who returned for scheduled follow-up clinic visits and had radiographic images taken
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Calcar Fracture | Number of Study participants with a calcar fracture noted on x-rays at 1 year | 0 Participants |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Calcar Fracture | Number of Study participants with a calcar fracture noted on x-rays at 2 years | 0 Participants |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Calcar Fracture | Number of Study participants with a calcar fracture noted on x-rays at 3 years | 0 Participants |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Calcar Fracture | Number of Study participants with a calcar fracture noted on x-rays at 4 years | 0 Participants |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Calcar Fracture | Number of Study participants with a calcar fracture noted on x-rays at 5 years | 0 Participants |
Secondary
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
Population: All study Participants who returned for scheduled follow-up clinic visits and had radiographic images taken
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Calcar Resorption | Study patients with calcar resorption indicated on x-rays at 1 year | 1 Participants |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Calcar Resorption | Study patients with calcar resorption indicated on x-rays at 2 years | 2 Participants |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Calcar Resorption | Study patients with calcar resorption indicated on x-rays at 3 years | 2 Participants |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Calcar Resorption | Study patients with calcar resorption indicated on x-rays at 4 years | 2 Participants |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Calcar Resorption | Study patients with calcar resorption indicated on x-rays at 5 years | 3 Participants |
Secondary
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
Population: All study Participants who returned for scheduled follow-up clinic visits and had radiographic images taken
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 1 year | Class 0 | 87 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 1 year | Class I | 21 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 1 year | Class II | 14 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 1 year | Class III | 3 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 1 year | Class IV | 0 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 1 year | Unable to assess | 2 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 2 years | Class 0 | 80 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 2 years | Class I | 21 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 2 years | Class II | 17 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 2 years | Class III | 6 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 2 years | Class IV | 0 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 2 years | Unable to assess | 0 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 3 years | Class 0 | 40 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 3 years | Class I | 13 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 3 years | Class II | 10 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 3 years | Class III | 3 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 3 years | Class IV | 0 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 3 years | Unable to assess | 0 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 4 years | Class 0 | 21 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 4 years | Class I | 8 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 4 years | Class II | 3 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 4 years | Class III | 3 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 4 years | Class IV | 0 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 4 years | Unable to assess | 0 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 5 years | Class 0 | 65 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 5 years | Class I | 21 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 5 years | Class II | 19 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 5 years | Class III | 4 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 5 years | Class IV | 0 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Heterotopic Ossification | Study Participant Femoral Heterotopic Ossification at 5 years | Unable to assess | 0 Participant hips |
Secondary
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
Population: All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Position | Femoral stem position in study patients at 5 year follow-up | Number with Valgus stem position | 8 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Position | Femoral stem position in study patients at 5 year follow-up | Number with Varus stem position | 34 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Position | Femoral stem position in study patients at 5 year follow-up | Unable to assess | 0 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Position | Femoral stem position in study patients at 5 year follow-up | Indeterminate | 0 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Position | Femoral stem position in study patients at 1 year follow-up | Number with Neutral stem position | 79 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Position | Femoral stem position in study patients at 1 year follow-up | Number with Valgus stem position | 10 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Position | Femoral stem position in study patients at 1 year follow-up | Number with Varus stem position | 35 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Position | Femoral stem position in study patients at 1 year follow-up | Unable to assess | 2 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Position | Femoral stem position in study patients at 1 year follow-up | Indeterminate | 1 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Position | Femoral stem position in study patients at 2 year follow-up | Number with Neutral stem position | 77 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Position | Femoral stem position in study patients at 2 year follow-up | Number with Valgus stem position | 9 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Position | Femoral stem position in study patients at 2 year follow-up | Number with Varus stem position | 38 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Position | Femoral stem position in study patients at 2 year follow-up | Unable to assess | 0 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Position | Femoral stem position in study patients at 2 year follow-up | Indeterminate | 0 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Position | Femoral stem position in study patients at 3 year follow-up | Number with Neutral stem position | 35 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Position | Femoral stem position in study patients at 3 year follow-up | Number with Valgus stem position | 6 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Position | Femoral stem position in study patients at 3 year follow-up | Number with Varus stem position | 24 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Position | Femoral stem position in study patients at 3 year follow-up | Unable to assess | 1 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Position | Femoral stem position in study patients at 3 year follow-up | Indeterminate | 0 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Position | Femoral stem position in study patients at 4 year follow-up | Number with Neutral stem position | 19 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Position | Femoral stem position in study patients at 4 year follow-up | Number with Valgus stem position | 4 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Position | Femoral stem position in study patients at 4 year follow-up | Number with Varus stem position | 12 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Position | Femoral stem position in study patients at 4 year follow-up | Unable to assess | 0 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Position | Femoral stem position in study patients at 4 year follow-up | Indeterminate | 0 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Position | Femoral stem position in study patients at 5 year follow-up | Number with Neutral stem position | 67 Participant hips |
Secondary
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
Population: All study Participants who returned for scheduled follow-up clinic visits and had radiographic images taken
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Sclerotic Lines | Number of study participants with femoral sclerotic lines present at 1 year | 1 Participants |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Sclerotic Lines | Number of study participants with femoral sclerotic lines present at 2 years | 5 Participants |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Sclerotic Lines | Number of study participants with femoral sclerotic lines present at 3 years | 5 Participants |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Sclerotic Lines | Number of study participants with femoral sclerotic lines present at 4 years | 1 Participants |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Sclerotic Lines | Number of study participants with femoral sclerotic lines present at 5 years | 7 Participants |
Secondary
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
Population: All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Subsidence | Number of study Participants with femoral stem subsidence greater that 2mm at 1 year | 0 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Subsidence | Number of study Participants with femoral stem subsidence greater that 2mm at 2 years | 0 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Subsidence | Number of study Participants with femoral stem subsidence greater that 2mm at 3 years | 0 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Subsidence | Number of study Participants with femoral stem subsidence greater that 2mm at 4 years | 0 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Subsidence | Number of study Participants with femoral stem subsidence greater that 2mm at 5 years | 0 Participant hips |
Secondary
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
Population: All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Tilt | Number of Study Participants with femoral tilt greater than 2 degrees at 3 years | 3 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Tilt | Number of Study Participants with femoral tilt greater than 2 degrees at 1 year | 3 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Tilt | Number of Study Participants with femoral tilt greater than 2 degrees at 2 years | 3 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Tilt | Number of Study Participants with femoral tilt greater than 2 degrees at 4 years | 2 Participant hips |
| CERAMAX COC 36mm Acetabular Cup | Femoral Stem Tilt | Number of Study Participants with femoral tilt greater than 2 degrees at 5 years | 5 Participant hips |
Secondary
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
Population: All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 4 years. Categories 0 - IV, and unable to assess | Class III | 2 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 4 years. Categories 0 - IV, and unable to assess | Class IV | 0 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 4 years. Categories 0 - IV, and unable to assess | Unable to assess | 0 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 1 year. Categories 0 - IV, and unable to assess | Class 0 | 87 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 1 year. Categories 0 - IV, and unable to assess | Class I | 15 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 1 year. Categories 0 - IV, and unable to assess | Class II | 21 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 1 year. Categories 0 - IV, and unable to assess | Class III | 3 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 1 year. Categories 0 - IV, and unable to assess | Class IV | 0 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 1 year. Categories 0 - IV, and unable to assess | Unable to assess | 1 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 2 years. Categories 0 - IV, and unable to assess | Class 0 | 78 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 2 years. Categories 0 - IV, and unable to assess | Class I | 17 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 2 years. Categories 0 - IV, and unable to assess | Class II | 25 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 2 years. Categories 0 - IV, and unable to assess | Class III | 4 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 2 years. Categories 0 - IV, and unable to assess | Class IV | 0 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 2 years. Categories 0 - IV, and unable to assess | Unable to assess | 0 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 3 years. Categories 0 - IV, and unable to assess | Class 0 | 32 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 3 years. Categories 0 - IV, and unable to assess | Class I | 10 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 3 years. Categories 0 - IV, and unable to assess | Class II | 22 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 3 years. Categories 0 - IV, and unable to assess | Class III | 2 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 3 years. Categories 0 - IV, and unable to assess | Class IV | 0 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 3 years. Categories 0 - IV, and unable to assess | Unable to assess | 0 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 4 years. Categories 0 - IV, and unable to assess | Class 0 | 21 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 4 years. Categories 0 - IV, and unable to assess | Class I | 5 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 4 years. Categories 0 - IV, and unable to assess | Class II | 7 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 5 years. Categories 0 - IV, and unable to assess | Class 0 | 64 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 5 years. Categories 0 - IV, and unable to assess | Class I | 16 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 5 years. Categories 0 - IV, and unable to assess | Class II | 26 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 5 years. Categories 0 - IV, and unable to assess | Class III | 3 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 5 years. Categories 0 - IV, and unable to assess | Class IV | 0 Participant Hips |
| CERAMAX COC 36mm Acetabular Cup | Heterotopic Ossification | Heterotopic Calcification at 5 years. Categories 0 - IV, and unable to assess | Unable to assess | 0 Participant Hips |
Secondary
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
Population: All study participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CERAMAX COC 36mm Acetabular Cup | Kaplan Meier Device Survivorship at Years 1 Through 6 | Kaplan Meier device survivorship at 4 years with 154 hips remaining | 95.3 Percentage of implants |
| CERAMAX COC 36mm Acetabular Cup | Kaplan Meier Device Survivorship at Years 1 Through 6 | Kaplan Meier device survivorship at 5 years with 150 hips remaining | 95.3 Percentage of implants |
| CERAMAX COC 36mm Acetabular Cup | Kaplan Meier Device Survivorship at Years 1 Through 6 | Kaplan Meier device survivorship at 1 year with 164 hips remaining | 97.7 Percentage of implants |
| CERAMAX COC 36mm Acetabular Cup | Kaplan Meier Device Survivorship at Years 1 Through 6 | Kaplan Meier device survivorship at 2 years with 161 hips remaining | 96.5 Percentage of implants |
| CERAMAX COC 36mm Acetabular Cup | Kaplan Meier Device Survivorship at Years 1 Through 6 | Kaplan Meier device survivorship at 3 years with 158 hips remaining | 95.9 Percentage of implants |
| CERAMAX COC 36mm Acetabular Cup | Kaplan Meier Device Survivorship at Years 1 Through 6 | Kaplan Meier device survivorship at 6 years with 58 hips remaining | 95.3 Percentage of implants |