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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CERAMAX COC 36mm Acetabular Cup | Other | The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COC 36mm | Device | Total Hip Replacement with COC 36mm Acetabular Cup System |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Years 1 through 6 post-operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terrence D Whalen, BS, DC | DePuy Orthopaedics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joint Surgeons of Sacremento | Sacramento | California | United States | |||
| Colorado Joint Replacement |
Not provided
All eligible patients were asked if they were interested in study participation
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 11, 2020 | Jan 6, 2025 |
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| 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 | 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) | 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) | Annually through 5 years |
| Acetabular Cup Version - Annual Measurements | Acetabular cup version is the angle formed between the axis of the implant and the coronal plane of the body. Acetabular version typically ranges between 11.5 and 28.5 degrees. | Measured from x-rays taken annually, years 1 through 5 |
| Acetabular Cup Inclination | Acetabular cup inclination is the angle between the longitudinal axis of the patient and a perpendicular line to the major axis of the cup projection. The target acetabular cup inclination is between 30-50 degrees | Measured from x-rays taken annually, years 1 through 5 |
| Acetabular Cup Migration | Acetabular migration is the superior migration of the implant within the pelvic bone | Measured from x-rays taken annually, years 1 through 5 |
| Heterotopic Ossification | Heterotopic ossification is the abnormal formation of bone in soft tissues, such as muscles, tendons, or ligaments and can occur around the hip joint, leading to pain, stiffness, and restricted range of motion. It is graded as Class 0 through Class IV, with Class 0 being least impactful and Class IV being most impactful | Measured from x-rays taken annually, years 1 through 5 |
| Acetabular Radiolucent Lines | Radiolucent lines are seen on x-rays and represent an area that is absent of bone. Radiolucent lines seen adjacent to an implant may suggest a lack on bone ingrowth or possible loosening of the implant. Radiolucent lines greater than 1mm wide were considered reportable for this study. | Measured from x-rays taken annually, years 1 through 5 |
| Acetabular Osteolysis | Osteolysis is seen on x-rays and represent an area where bone has been resorbed by the body in response to small particles of debris that are created as an implant wears over time. Osteolysis greater than 5mm was considered to be reportable for this study. | Measured from x-rays taken annually, years 1 through 5 |
| Acetabular Sclerotic Lines | Acetabular sclerotic lines are seen on x-rays and are radio-dense areas of bone that have remodeled due to loads close to the implant. | Measured from x-rays taken annually, years 1 though 5 |
| Femoral Stem Position | Femoral stem position is categorized as neutral, valgus, or varus. A neutral stem is centered within the femoral canal that runs through the center of the femur's long axis. A valgus femoral stem is positioned slightly towards the medial side of the femoral canal, and a varus femoral stem is positioned slightly towards the lateral side of the femoral canal. | Measured from x-rays taken annually, years 1 through 5 |
| Femoral Stem Tilt | Femoral stem tilt is a measurement taken at each post-operative year and compared against baseline images collected at 6-weeks post-operative. The measurement captures changes in the position of the femoral stem over time. Tilt greater than 2 degrees was considered reportable for this study | Measured from x-rays taken annually, years 1 through 5 |
| Femoral Stem Subsidence | Femoral stem subsidence is the inferior movement of the stem within the femoral canal. Subsidence greater than 2 mm was considered reportable for this study. | Measured from x-rays taken annually, years 1 through 5 |
| Femoral Stem Heterotopic Ossification | Heterotopic ossification is the abnormal formation of bone in soft tissues such as muscles, tendons, or ligaments and can occur around the hip joint, leading to pain, stiffness, and restricted range of motion. It is graded as Class 0 through Class IV, with Class O having no bone growth in soft tissue, Class I being least impactful and Class IV being most impactful. | Measured from x-rays taken annually, years 1 through 5 |
| Femoral Radiolucent Lines | Radiolucencies are seen on x-rays and represent an area that is absent of bone. Radiolucent lines seen adjacent to an implant may suggest a lack of bone ingrowth into the implant or possible loosening of the implant | Measured from x-rays taken annually, years 1 through 5 |
| Femoral Osteolysis | Osteolysis is seen on x-rays and represent an area where bone has been resorbed by the body in response to small particles of debris that are created as an implant wears over time. Osteolysis greater than 5mm was considered to be reportable for this study. | Measured from x-rays taken annually, years 1 through 5 |
| Femoral Stem Sclerotic Lines | Acetabular sclerotic lines are seen on x-rays and are radio-dense areas of bone that have remodeled due to loads close to the implant. | Measured 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 | Measure from x-rays taken annually, years 1 through 5 |
| Femoral Stem Calcar Fracture | Near the top of the femur is a region of bone called the calcar femorale that provides strength to the femur when compressive forces are applied. During preparation of the femur to receive the femoral implant there is the possibility of fractures occurring in this region | Measured from x-rays taken annually, years 1 through 5 |
| Denver |
| Colorado |
| United States |
| Florida Orthopaedic Institute | Tampa | Florida | United States |
| Arthroplasty Foundation | Louisville | Kentucky | United States |
| TUFTS - New England Medical Center | Boston | Massachusetts | 02111 | United States |
| New England Baptist Hospital | Boston | Massachusetts | 02120 | United States |
| Samuel Wellman, MD / Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| Orthopedic One | Columbus | Ohio | 43213 | United States |
| UPenn | Philadelphia | Pennsylvania | 19104 | United States |
| QEII Health Sciences Centre | Halifax | Nova Scotia | Canada |
| London Health Sciences Centre - University Hospital | London | Ontario | Canada |
| Queens University - Kingston General Hospital | Kingston | Quebec | Canada |
| McGill University - Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All study Participants (n=170)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age in years of study participants (n=170) | All study participants (n=170) | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Participant gender (n=170) | Study Participant Gender | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Study Participant Ethnicity | Study Participants | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Study Participant Race | Study Participants | Count of Participants | Participants |
| ||||||||||||||||
| Study Participant Primary Diagnosis | Study Participant Primary Diagnosis | Study Participants | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All Study Participants | Posted | Number | 95% Confidence Interval | Percentage of implants | 5 years | Implants | Implants |
|
|
| |||||||||||||||||||||||||
| 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. | All study participants | Posted | Number | 95% Confidence Interval | Percentage of implants | Years 1 through 6 post-operatively | Implants | Implants |
|
| ||||||||||||||||||||||||||
| 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 | All study participants who attended their annual clinical evaluation | Posted | Count of Units | Participant hips | Annually through 5 years | Participant hips | 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) | All study participants who attended their annual clinical evaluation | Posted | Count of Units | Participant hips | Annually through 5 years | Participant hips | 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) | All Study Participants who attended their annual clinical evaluation | Posted | Count of Units | Participant Hips | Annually through 5 years | Participant Hips | 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. | All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken | Posted | Mean | Standard Deviation | Degrees | Measured from x-rays taken annually, years 1 through 5 | Participant hips | Participant hips |
|
| ||||||||||||||||||||||||||
| 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 | All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken | Posted | Mean | Standard Deviation | Degrees | Measured from x-rays taken annually, years 1 through 5 | Participant Hips | Participant Hips |
|
| ||||||||||||||||||||||||||
| Secondary | Acetabular Cup Migration | Acetabular migration is the superior migration of the implant within the pelvic bone | All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken | Posted | Count of Units | Participant Hips | Measured from x-rays taken annually, years 1 through 5 | Participant Hips | 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 | All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken | Posted | Count of Units | Participant Hips | Measured from x-rays taken annually, years 1 through 5 | Participant Hips | 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. | All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken | Posted | Count of Units | Participant hips | Measured from x-rays taken annually, years 1 through 5 | Participant hips | Participant hips |
|
| |||||||||||||||||||||||||||
| 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. | All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken | Posted | Count of Units | Participant hips | Measured from x-rays taken annually, years 1 through 5 | Participant hips | 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. | All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken | Posted | Count of Units | Participant Hips | Measured from x-rays taken annually, years 1 though 5 | Participant Hips | 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. | All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken | Posted | Count of Units | Participant hips | Measured from x-rays taken annually, years 1 through 5 | Participant hips | 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 | All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken | Posted | Count of Units | Participant hips | Measured from x-rays taken annually, years 1 through 5 | Participant hips | Participant hips |
|
| |||||||||||||||||||||||||||
| 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. | All study participants who returned for scheduled follow-up clinic visits and had radiographic images taken | Posted | Count of Units | Participant hips | Measured from x-rays taken annually, years 1 through 5 | Participant hips | Participant hips |
|
| |||||||||||||||||||||||||||
| 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. | All study Participants who returned for scheduled follow-up clinic visits and had radiographic images taken | Posted | Count of Units | Participant hips | Measured from x-rays taken annually, years 1 through 5 | Participant hips | Participant hips |
|
| |||||||||||||||||||||||||||
| 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 | All study Participants who returned for scheduled follow-up clinic visits and had radiographic images taken | Posted | Number | Participants | Measured from x-rays taken annually, years 1 through 5 | Participant Hips | 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. | All study Participants who returned for scheduled follow-up clinic visits and had radiographic images taken | Posted | Number | Participants | Measured from x-rays taken annually, years 1 through 5 | Participant Hips | 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. | All study Participants who returned for scheduled follow-up clinic visits and had radiographic images taken | Posted | Number | Participants | Measured from x-rays taken annually, years 1 through 5 | Participant Hips | Participant Hips |
|
| |||||||||||||||||||||||||||
| 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 | All study Participants who returned for scheduled follow-up clinic visits and had radiographic images taken | Posted | Number | Participants | Measure from x-rays taken annually, years 1 through 5 | Participant Hips | Participant Hips |
|
| |||||||||||||||||||||||||||
| 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 | All study Participants who returned for scheduled follow-up clinic visits and had radiographic images taken | Posted | Number | Participants | Measured from x-rays taken annually, years 1 through 5 | Participant hips | Participant hips |
|
|
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Adverse events were collected throughout the course of the study and continued until the 5-year interval when the study closed
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 2 | 170 | 86 | 170 | 141 | 170 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Foetal heart rate deceleration abnormality | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Developmental hip dysplasia | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Anal stenosis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Incarcerated umbilical hernia | Gastrointestinal disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Haematoma infection | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Medical device site joint infection | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Metapneumovirus infection | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
| |
| Joint effusion | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
| |
| Joint instability | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
| |
| Periprosthetic fracture | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
| |
| Wound secretion | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Extraskeletal ossification | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Intervertebral disc displacement | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Joint crepitation | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Osteomyelitis | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Pseudarthrosis | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Spondylitis | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Synovial disorder | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA19.0 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA19.0 | Non-systematic Assessment |
| |
| Clear cell renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA19.0 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA19.0 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA19.0 | Non-systematic Assessment |
| |
| Parathyroid tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA19.0 | Non-systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA19.0 | Non-systematic Assessment |
| |
| Alcoholic seizure | Nervous system disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Amyotrophic lateral sclerosis | Nervous system disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Peroneal nerve palsy | Nervous system disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Device failure | Product Issues | MedDRA19.0 | Non-systematic Assessment |
| |
| Device loosening | Product Issues | MedDRA19.0 | Non-systematic Assessment |
| |
| Delirium tremens | Psychiatric disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Homicidal ideation | Psychiatric disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Bladder neck obstruction | Renal and urinary disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Rectocele | Reproductive system and breast disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Laryngeal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Joint crepitation | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dave Whalen | Johnson & Johnson MedTech | 574-404-9399 | dwhalen@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 20, 2023 | Jan 6, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Post Traumatic Arthritis |
|
| Implants |
|
|
| Participant hips |
|
|
| Participant hips |
|
|
| Participant Hips |
|
|
| Participant hips |
|
|
| Participant Hips |
|
|
| Participant Hips |
|
|
| Participant Hips |
|
|
| Participant hips |
|
|
| Participant hips |
|
|
| Participant Hips |
|
|
| Participant hips |
|
|
| Participant hips |
|
|
| Participant hips |
|
|
| Participant hips |
|
|
| Participant Hips |
|
|
| Participant Hips |
|
|
| Participant Hips |
|
|
| Participant Hips |
|
|
| Participant hips |
|
|
| Class II |
|
| Class III |
|
| Class IV |
|
| Unable to assess |
|
| Class II |
|
| Class III |
|
| Class IV |
|
| Unable to assess |
|
| Class II |
|
| Class III |
|
| Class IV |
|
| Unable to assess |
|
| Class II |
|
| Class III |
|
| Class IV |
|
| Unable to assess |
|
| Number with Varus stem position |
|
| Unable to assess |
|
| Indeterminate |
|
| Number with Varus stem position |
|
| Unable to assess |
|
| Indeterminate |
|
| Number with Varus stem position |
|
| Unable to assess |
|
| Indeterminate |
|
| Number with Varus stem position |
|
| Unable to assess |
|
| Indeterminate |
|
| Class II |
|
| Class III |
|
| Class IV |
|
| Unable to assess |
|
| Class II |
|
| Class III |
|
| Class IV |
|
| Unable to assess |
|
| Class II |
|
| Class III |
|
| Class IV |
|
| Unable to assess |
|
| Class II |
|
| Class III |
|
| Class IV |
|
| Unable to assess |
|