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The objective of this study is to determine the long-term safety and effectiveness from the R3 Acetabular Hip System. The study hypothesis is that implant survivorship of the R3 cup is at least 97% at 3 years, 95% at 5 years, 93% at 7 years, and 90% at 10 years follow-up.
This is a multicenter prospective observational post-market clinical follow-up study that will include 500 patients who will have total hip replacement with the R3 Acetabular System and either cemented or cementless hip stem.
Effectiveness will be assessed by comparison of changes in parameters contained in the HOOS questionnaire and based upon incidence of revision and change in Harris Hip Score and UCLA Rating. Safety will be measured by assessing all adverse events experienced by patients from study enrolment through to study completion.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Hip Arthroplasty | Device | Total hip arthroplasty with the R3 Acetabular Hip system. |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survivorship | Implant survivorship by 10 years post study procedure measured by Kaplan-Meier survival rate. Implant survival determined by no revision required for any reason. A revision is a surgical procedure of the study hip where one or more of the study components are removed and replaced with new implants. | up to 10 years post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS) | HOOS is a measurement of function and outcomes of daily living that ranges from 0 to 100 where 0 indicated extreme symptoms (i.e., worse outcome) and 100 indicated no symptoms (i.e., better outcome). | Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years |
Not provided
Inclusion Criteria:
Subjects must meet all of the following characteristics for inclusion in the study.
Exclusion Criteria:
Subjects with any of the following characteristics must be excluded from the participation in the study.
Not provided
Not provided
This clinical study can fulfill its objectives only if appropriate subjects are enrolled. All relevant medical and non-medical conditions should be taken into consideration when deciding whether a particular patient is suitable. Subjects will be enrolled consecutively.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Remes, Associate Professor | University of Helsinki | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Nikolaas | Sint-Niklaas | Moerlandstraat 1 | 9100 | Belgium | ||
| Hvidovre University Hospital |
The data from one (1) enrolled hip (1 participant) were entirely removed due to questions regarding the validity of the participant's consent.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | R3â„¢ Acetabular System | Total hip replacement with the R3â„¢ Acetabular System (cemented or cementless hip stem) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | R3â„¢ Acetabular System | Total hip replacement with the R3â„¢ Acetabular System (cemented or cementless hip stem) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Implant Survivorship | Implant survivorship by 10 years post study procedure measured by Kaplan-Meier survival rate. Implant survival determined by no revision required for any reason. A revision is a surgical procedure of the study hip where one or more of the study components are removed and replaced with new implants. | Safety Analysis Population (SAF) included participants enrolled and implanted with the study device with data collected for the time frame indicated. | Posted | Number | 95% Confidence Interval | percentage of hips | up to 10 years post-operatively | hips | hips |
|
Adverse Events were collected following implantation of the R3â„¢ Acetabular System through 10 years.
All adverse events (AE), regardless of their relationship to the study device were included in the safety analyses. Total participants at risk for each adverse event type (i.e., All Cause Mortality, Serious, and Other) indicates those with available AE data collected.
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 | R3â„¢ Acetabular System | Total hip replacement with the R3â„¢ Acetabular System (cemented or cementless hip stem) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bursitis | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain related to hip | Injury, poisoning and procedural complications | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fleur Derdeyn, Clinical Study Manager | Smith & Nephew | +32497602032 | fleur.derdeyn@smith-nephew.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 1, 2017 | Dec 6, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 6, 2022 | Dec 6, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
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| Patient Reported Outcome (PRO): Modified Harris Hip Score (mHHS) | The mHHS scoring assessment ranges from 0 (worst) to 100 (best). Scores assessed during the pre-operative, 3-year, 5-year, 7-year and 10-year visit. | Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years |
| Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) Rating | UCLA Activity Score is a measure of physical activity levels in participants undergoing total joint arthroplasty. The scale ranges from 1 to 10 with higher scores indicating greater physical function (i.e., a better outcome). | Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years |
| Radiographic Findings: Atrophy | Number of participant hips with radiographic findings for atrophy indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, & 10 years for the following:
| 1 years, 3 years, 5 years, 7 years, 10 years |
| Radiographic Findings: Hypertrophy | Number of participant hips with radiographic findings for hypertrophy indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, & 10 years for the following:
| 1 years, 3 years, 5 years, 7 years, 10 years |
| Radiographic Findings: Osteolysis | Number of participant hips with radiographic findings for osteolysis greater than 2 millimeters in any cup or stem zones indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, & 10 years as the following:
| 1 years, 3 years, 5 years, 7 years, 10 years |
| Radiographic Findings: Radiolucent Lines (RLL) | Number of participant hips with radiographic findings for radiolucent lines (RLL) greater than 2 millimeters in any cup or stem zones indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, & 10 years as the following:
| 1 years, 3 years, 5 years, 7 years, 10 years |
| Hvidovre |
| 2650 |
| Denmark |
| Helsinki University Hospital | Helsinki | FI-00029 | Finland |
| TYKS Turku University Hospital | Turku | 20880 | Finland |
| Knappschaftskrankenhaus Püttlingen | Püttlingen | 66346 | Germany |
| Medisch Centrum Alkmaar | Alkmaar | 1815 JD | Netherlands |
| University Hospital La Paz | Madrid | 28046 | Spain |
| The Royal Orthopaedic Hospital, NHS Foundation Trust | Birmingham | B 31 2AP | United Kingdom |
| hips |
|
| years |
| hips |
|
|
| Sex: Female, Male | Count of Units | hips | hips |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | hips | hips |
|
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 | hips |
|
|
| Units | Counts |
|---|
| Participants |
|
| hips |
|
|
| Secondary | Patient Reported Outcome (PRO): Hip Disability and Osteoarthritis Outcome Score (HOOS) | HOOS is a measurement of function and outcomes of daily living that ranges from 0 to 100 where 0 indicated extreme symptoms (i.e., worse outcome) and 100 indicated no symptoms (i.e., better outcome). | Full Analysis Set (FAS) population included participants enrolled and implanted with the study device with data available from at least one post-operative assessment for the time frame indicated. | Posted | Mean | Standard Deviation | score on a scale | Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years | hips | hips |
|
|
|
| Secondary | Patient Reported Outcome (PRO): Modified Harris Hip Score (mHHS) | The mHHS scoring assessment ranges from 0 (worst) to 100 (best). Scores assessed during the pre-operative, 3-year, 5-year, 7-year and 10-year visit. | Safety Analysis Population (SAF) included participants enrolled and implanted with the study device with data collected for the time frame indicated. | Posted | Mean | Standard Deviation | score on a scale | Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years | hips | hips |
|
|
|
| Secondary | Patient Reported Outcome (PRO): University of California, Los Angeles (UCLA) Rating | UCLA Activity Score is a measure of physical activity levels in participants undergoing total joint arthroplasty. The scale ranges from 1 to 10 with higher scores indicating greater physical function (i.e., a better outcome). | Safety Analysis Population (SAF) included participants enrolled and implanted with the study device with data collected for the time frame indicated. | Posted | Mean | Standard Deviation | score on a scale | Pre-operative, 3 months, 1 years, 3 years, 5 years, 7 years, 10 years | hips | hips |
|
|
|
| Secondary | Radiographic Findings: Atrophy | Number of participant hips with radiographic findings for atrophy indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, & 10 years for the following:
| Participants enrolled and implanted with the study device with data collected from at least one post-operative assessment for the time frame indicated. | Posted | Count of Units | hips | 1 years, 3 years, 5 years, 7 years, 10 years | hips | hips |
|
|
|
| Secondary | Radiographic Findings: Hypertrophy | Number of participant hips with radiographic findings for hypertrophy indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, & 10 years for the following:
| Participants enrolled and implanted with the study device with data collected from at least one post-operative assessment for the time frame indicated. | Posted | Count of Units | hips | 1 years, 3 years, 5 years, 7 years, 10 years | hips | hips |
|
|
|
| Secondary | Radiographic Findings: Osteolysis | Number of participant hips with radiographic findings for osteolysis greater than 2 millimeters in any cup or stem zones indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, & 10 years as the following:
| Participants enrolled and implanted with the study device with data collected from at least one post-operative assessment for the time frame indicated. | Posted | Count of Units | hips | 1 years, 3 years, 5 years, 7 years, 10 years | hips | hips |
|
|
|
| Secondary | Radiographic Findings: Radiolucent Lines (RLL) | Number of participant hips with radiographic findings for radiolucent lines (RLL) greater than 2 millimeters in any cup or stem zones indicated with a 'No', 'Yes', or 'N/A' (response not available) response at 1 year, 3 years, 5 years, 7 years, & 10 years as the following:
| Participants enrolled and implanted with the study device with data collected from at least one post-operative assessment for the time frame indicated. | Posted | Count of Units | hips | 1 years, 3 years, 5 years, 7 years, 10 years | hips | hips |
|
|
|
| 37 |
| 478 |
| 371 |
| 478 |
| 329 |
| 478 |
| Cyst | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Death from unknown causes | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Deep Infection <6 weeks | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Deep Infection >6 weeks | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Deep Vein Thrombosis | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Delayed Wound Healing | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Disturbance of skin sensation | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Elevated Metal Ions | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Fissure | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Groin pain, study hip side | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hematoma, Hemarthrosis | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Inflammation | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Injury, poisoning, or consequence of external causes | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Leg Length Change | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Leg Pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Limp, study hip side | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Myalgia, muscle pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Operative side pain originating from other than study hip | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pain in study hip | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Perioperative Fever | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Perioperative Pulmonary Embolism | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Post-op swelling of study leg | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pseudotumor | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Reaction to metal debris/ metal allergy | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Tendonitis | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Trochanteritis | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Eye/Adnexa | Eye disorders | Systematic Assessment |
|
| Death from unknown causes | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Symptoms not otherwise defined | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Circulatory | Cardiac disorders | Systematic Assessment |
|
| Death from unknown causes | Cardiac disorders | Systematic Assessment |
|
| Nervous | Nervous system disorders | Systematic Assessment |
|
| Pain, unknown etiology | Nervous system disorders | Systematic Assessment |
|
| Symptoms not otherwise defined | Nervous system disorders | Systematic Assessment |
|
| Death from unknown causes | General disorders | Systematic Assessment |
|
| Pain, unknown etiology | General disorders | Systematic Assessment |
|
| Lymphatic | Blood and lymphatic system disorders | Systematic Assessment |
|
| Skin/Subcutaneous Tissue | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Ear/Mastoid Process | Ear and labyrinth disorders | Systematic Assessment |
|
| Mental/behavioral | Psychiatric disorders | Systematic Assessment |
|
| Digestive/Gastrointestinal | Hepatobiliary disorders | Systematic Assessment |
|
| Bone Fracture- Femur | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Digestive/Gastrointestinal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dislocation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Heterotopic Ossification: Grade I | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscular/Connective Tissue | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain, unknown etiology | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Skeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Superficial Infection Only | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Symptoms not otherwise defined | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cancer, known origin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Cancer, unknown type | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Death from unknown causes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Urinary | Renal and urinary disorders | Systematic Assessment |
|
| Reproductive System | Reproductive system and breast disorders | Systematic Assessment |
|
| Circulatory | Vascular disorders | Systematic Assessment |
|
| Death from unknown causes | Vascular disorders | Systematic Assessment |
|
| Hematologic/Immune System | Vascular disorders | Systematic Assessment |
|
| Endocrine/Nutritional/Metabolic | Metabolism and nutrition disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Digestive/Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
|
| Acetabular | Product Issues | Systematic Assessment |
|
| Femoral | Product Issues | Systematic Assessment |
|
| Femoral Component | Product Issues | Systematic Assessment |
|
| Implant Failure | Product Issues | Systematic Assessment |
|
| Other | Product Issues | Systematic Assessment |
|
| Endocrine/Nutritional/Metabolic | Endocrine disorders | Systematic Assessment |
|
| Bursitis | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Deep Infection <6 weeks | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Delayed Wound Healing | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Disturbance of skin sensation | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Ectopic Bone Formation | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Elevated Metal Ions | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Fissure | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Fluid Accumulation | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Groin pain, study hip side | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hematoma, Hemarthrosis | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hip Discomfort, soreness, or cramping, may be intermittent | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hip Squeaking/Clicking/Popping/Snapping or other noise | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Inflammation | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Injury, poisoning, or consequence of external causes | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Leg Pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Limp, study hip side | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Myalgia, muscle pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Operative side pain originating from other than study hip | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pain at Op site | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pain in study hip | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Periaticular Calcification | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Perioperative Fever | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Post-op swelling of study leg | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pseudotumor | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Psoas Tenopathy | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Reaction to metal debris/ metal allergy | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Stiffness | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Stress Shielding | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Tenderness in the trochanteric region | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Trendelenberg gait | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Trochanteritis | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Weakness in study leg | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Wound Dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Eye/Adnexa | Eye disorders | Systematic Assessment |
|
| Other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Symptoms not otherwise defined | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Circulatory | Cardiac disorders | Systematic Assessment |
|
| Nervous | Nervous system disorders | Systematic Assessment |
|
| Pain, unknown etiology | Nervous system disorders | Systematic Assessment |
|
| Symptoms not otherwise defined | Nervous system disorders | Systematic Assessment |
|
| Other | General disorders | Systematic Assessment |
|
| Pain, unknown etiology | General disorders | Systematic Assessment |
|
| Symptoms not otherwise defined | General disorders | Systematic Assessment |
|
| Lymphatic | Blood and lymphatic system disorders | Systematic Assessment |
|
| Other | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin/Subcutaneous Tissue | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Ear/Mastoid Process | Ear and labyrinth disorders | Systematic Assessment |
|
| Special Sense | Ear and labyrinth disorders | Systematic Assessment |
|
| Mental/behavioral | Psychiatric disorders | Systematic Assessment |
|
| Bone Fracture- Femur | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cortical Thickening | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Digestive/Gastrointestinal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Endocrine/Nutritional/Metabolic | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fracture-Subtrochanteric | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Heterotopic Ossification- Generic Reporting | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Heterotopic Ossification: Grade I | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscular/Connective Tissue | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Osteolysis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain, unknown etiology | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Skeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Subluxation, no component specified | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Superficial Infection Only | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Symptoms not otherwise defined | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cancer, known origin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Urinary | Renal and urinary disorders | Systematic Assessment |
|
| Pain, unknown etiology | Reproductive system and breast disorders | Systematic Assessment |
|
| Reproductive System | Reproductive system and breast disorders | Systematic Assessment |
|
| Urinary | Reproductive system and breast disorders | Systematic Assessment |
|
| Circulatory | Vascular disorders | Systematic Assessment |
|
| Hematologic/Immune System | Vascular disorders | Systematic Assessment |
|
| Symptoms not otherwise defined | Vascular disorders | Systematic Assessment |
|
| Endocrine/Nutritional/Metabolic | Metabolism and nutrition disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Digestive/Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
|
| Symptoms not otherwise defined | Gastrointestinal disorders | Systematic Assessment |
|
| Femoral Component | Product Issues | Systematic Assessment |
|
| Endocrine/Nutritional/Metabolic | Endocrine disorders | Systematic Assessment |
|
Not provided
Not provided
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
| 3 Months |
|
|
| 1 Year |
|
|
| 3 Years |
|
|
| 5 Years |
|
|
| 7 Years |
|
|
| 10 Years |
|
|
| 3 Months |
|
|
| 1 Year |
|
|
| 3 Years |
|
|
| 5 Years |
|
|
| 7 Years |
|
|
| 10 Years |
|
|
| 3 Months |
|
|
| 1 Year |
|
|
| 3 Years |
|
|
| 5 Years |
|
|
| 7 Years |
|
|
| 10 Years |
|
|
| Yes |
|
| N/A |
|
| 1 Year: Atrophy in any Stem Zones |
|
|
| 3 Years: Atrophy in any Cup Zones |
|
|
| 3 Years: Atrophy in any Stem Zones |
|
|
| 5 Years: Atrophy in any Cup Zones |
|
|
| 5 Years: Atrophy in any Stem Zones |
|
|
| 7 Years: Atrophy in any Cup Zones |
|
|
| 7 Years: Atrophy in any Stem Zones |
|
|
| 10 Years: Atrophy in any Cup Zones |
|
|
| 10 Years: Atrophy in any Stem Zones |
|
|
| Yes |
|
| N/A |
|
| 1 Year: Hypertrophy in any Stem Zones |
|
|
| 3 Years: Hypertrophy in any Cup Zones |
|
|
| 3 Years: Hypertrophy in any Stem Zones |
|
|
| 5 Years: Hypertrophy in any Cup Zones |
|
|
| 5 Years: Hypertrophy in any Stem Zones |
|
|
| 7 Years: Hypertrophy in any Cup Zones |
|
|
| 7 Years: Hypertrophy in any Stem Zones |
|
|
| 10 Years: Hypertrophy in any Cup Zones |
|
|
| 10 Years: Hypertrophy in any Stem Zones |
|
|
| Yes |
|
| N/A |
|
| 1 Year: Osteolysis > 2mm in any Stem Zones |
|
|
| 3 Years: Osteolysis > 2mm in any Cup Zones |
|
|
| 3 Years: Osteolysis > 2mm in any Stem Zones |
|
|
| 5 Years: Osteolysis > 2mm in any Cup Zones |
|
|
| 5 Years: Osteolysis > 2mm in any Stem Zones |
|
|
| 7 Years: Osteolysis > 2mm in any Cup Zones |
|
|
| 7 Years: Osteolysis > 2mm in any Stem Zones |
|
|
| 10 Years: Osteolysis > 2mm in any Cup Zones |
|
|
| 10 Years: Osteolysis > 2mm in any Stem Zones |
|
|
| Yes |
|
| N/A |
|
| 1 Year: RLL > 2mm in any Stem Zones |
|
|
| 3 Years: RLL > 2mm in any Cup Zones |
|
|
| 3 Years: RLL > 2mm in any Stem Zones |
|
|
| 5 Years: RLL > 2mm in any Cup Zones |
|
|
| 5 Years: RLL > 2mm in any Stem Zones |
|
|
| 7 Years: RLL > 2mm in any Cup Zones |
|
|
| 7 Years: RLL > 2mm in any Stem Zones |
|
|
| 10 Years: RLL > 2mm in any Cup Zones |
|
|
| 10 Years: RLL > 2mm in any Stem Zones |
|
|