Not provided
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The purpose of this study is to assess the early and long term safety and efficacy of the hard-on-hard total hip replacement system (R3 ODH-ODH utilization) in patients with non-inflammatory arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Total Hip Replacement Device | Active Comparator | Total Hip replacement surgery using control device consisting of a hard-on-soft bearing or a ceramic-on-ceramic bearing which includes:
|
|
| Investigational Hard-on-Hard Total Hip Replacement Device | Experimental | Total Hip replacement surgery using an experimental device consisting of a hard-on-hard bearing which includes:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ODH Hip System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Device-Related Revisions | Device related revisions reported by the number of participants with a revision required (Yes/No). | Postoperatively through 10 years |
| Metal Ion Concentration in Whole Blood | For both investigational (i.e., Investigational Hard-on-Hard Total Hip Replacement Device) and control (i.e., Control Total Hip Replacement Device) participants, metal ion concentration in whole blood were measured for Cobalt (Co), Chromium (Cr), Nickel (Ni), Titanium (Ti), Zirconium (Zr), Niobium (Nb), Molybdenum (Mo), Vanadium (V) and Aluminum (Al) at each indicated time frame. | 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score (HHS) - Investigational Hard-on-Hard Total Hip Replacement Device Only | The Harris Hip Score (HHS), which ranges from 0 (worst) to 100 (best), considers information on pain, function, and range of motion. HHS was measured for Investigational Hard-on-Hard Total Hip Replacement Device only. | Preoperatively, 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operatively. |
Not provided
Inclusion Criteria:
At least 21 years old
Skeletally mature
Requires primary, unilateral total hip arthroplasty due to degenerative join disease
Preoperative Harris Hip Score of less than or equal to 70
Meets an acceptable preoperative medical clearance and is free or treated for conditions that would pose excessive operative risk
Given consent to participate in the study
Able to understand the purpose of the study, his/her role, and is available for follow-up
10 year extension:
Exclusion Criteria:
Diagnosis with high risk of Total Hip Arthroplasty (THA) failure
Requires bilateral THA
Requires revision of a prior hip replacement
Active infection or sepsis
History of local hip infection
Known metastatic or neoplastic disease
Conditions that may interfere with THA survival or outcomes
Need for structural bone grafts to support the implant
Contralateral lower extremity condition
Has other joint replacements or plans for other joint replacements within 2 years
Systemic steroid therapy within 3 months prior to surgery
Life expectancy less than 2 years
Intra-articular therapy within 6 months of enrollment
Female of child-bearing age not using contraception
Inadequate bone stock to support the device
Moderate to severe renal insufficiency
Emotional or neurological condition that would pre-empt ability or willingness to participate in the study
BMI >40
Above the knee amputation of the contralateral or ipsilateral leg
Known allergies to the components of the devices
Entered into another investigational study
Is a prisoner
10 year extension:
• In the opinion of the surgeon, the subject's health, safety or well-being may be compromised or harmed by continuation in the extension phase or participation may not be in the subject's best interests.
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Baker | Entabeni Hospital | Principal Investigator |
| Johannes de Beer | Zuid Afrikaans Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Entabeni Hospital | Durban | 4001 | South Africa | |||
| Zuid Afrikaans Hospital |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Investigational Hard-on-Hard Total Hip Replacement Device | Total Hip replacement surgery using an experimental device consisting of a hard-on-hard bearing which includes:
|
| FG001 | Control Total Hip Replacement Device | Total Hip replacement surgery using control device consisting of a hard-on-soft bearing or a ceramic-on-ceramic bearing which includes:
|
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Investigational Hard-on-Hard Total Hip Replacement Device | Total Hip replacement surgery using an experimental device consisting of a hard-on-hard bearing which includes:
|
| 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 | Number of Participants With Device-Related Revisions | Device related revisions reported by the number of participants with a revision required (Yes/No). | The safety population (SAF) included all participants enrolled in the study that received the study treatment with data available at the time frame indicated. | Posted | Count of Participants | Participants | Postoperatively through 10 years |
|
Surgery to 10-years
Not provided
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 | Investigational Hard-on-Hard Total Hip Replacement Device | Total Hip replacement surgery using an experimental device consisting of a hard-on-hard bearing which includes:
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Kidney Stones | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased Vanadium Levels | Blood and lymphatic system disorders | Systematic Assessment |
This study was initially conducted as a pilot study to assess early safety of the ODH on ODH Total Hip System in a small group of participants for up to two years. The study was then extended to include safety data for up to ten years. Imbalance of study arms and small sample size limits the amount of statistical conclusions the study can make. Not all data for Control participants were collected in every outcome measure, limiting the ability to compare the two arms.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study Manager | Smith and Nephew | 0499905851 | +61 | stephanie.rufo@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 | Jan 19, 2017 | May 15, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 26, 2018 | Apr 30, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic 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
Not provided
Not provided
Not provided
Not provided
Not provided
| Hip Disability and Osteoarthritis Outcome Scores (HOOS) | The Hip Disability and Osteoarthritis Outcome Scores (HOOS) was measured for Investigational Hard-on-Hard Total Hip Replacement Device only and included 40 items with five responses from five subcategories of Pain, Symptoms and Stiffness, Activities of Daily Living, Function in Sports and Recreational Activities, and Quality of Life to produce a total HOOS. The total HOOS scale ranged from 0 to 100, with 0 indicating the worst possible score and 100 indicating the best possible score. | Preoperatively, 3 months, 6 months, 1 year, 2 years, 5 years, 7 years, 10 years |
| Radiographic Measures: Radiolucencies | Radiolucencies determined by number of participants with occurrence of radiolucent lines and osteolysis (Yes/No) | 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative |
| Radiographic Measures: Heterotopic Ossification | Occurrence of Heterotopic Ossification in participants (Yes/No) | 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative |
| Radiographic Measures: Subsidence | Occurrence of Subsidence in Investigational Hard-on-Hard Total Hip Replacement Device participants (Yes/No) categorized by:
| 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative |
| Health Economic Outcomes: Surgical Blood Loss | Blood loss during surgery measured in milliliters (ml) of blood | Intra-operative, up to 50 minutes |
| Health Economic Outcomes: Length of Hospital Stay | Length of stay measured by number of days spent in hospital | Hospital admission to discharge |
| Health Economic Outcomes: Operative Time | Operative time in minutes from first incision into skin to time when last suture is applied for the Investigational Hard-on-Hard Total Hip Replacement Device group only | Intra-operative |
| Health Economic Outcomes: Re-Hospitalizations | Re-hospitalizations measured by the number of re-admissions to hospital | Up to 10 years |
| Pretoria |
| 0002 |
| South Africa |
| Removal/revision of device |
|
| Death |
|
| BG001 | Control Total Hip Replacement Device | Total Hip replacement surgery using control device consisting of a hard-on-soft bearing or a ceramic-on-ceramic bearing which includes:
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Treated Hip Side | Count of Participants | Participants |
|
| Medical History - Primary Diagnosis | Count of Participants | Participants |
|
| OG001 | Control Total Hip Replacement Device | Total Hip replacement surgery using control device consisting of a hard-on-soft bearing or a ceramic-on-ceramic bearing which includes:
|
|
|
| Primary | Metal Ion Concentration in Whole Blood | For both investigational (i.e., Investigational Hard-on-Hard Total Hip Replacement Device) and control (i.e., Control Total Hip Replacement Device) participants, metal ion concentration in whole blood were measured for Cobalt (Co), Chromium (Cr), Nickel (Ni), Titanium (Ti), Zirconium (Zr), Niobium (Nb), Molybdenum (Mo), Vanadium (V) and Aluminum (Al) at each indicated time frame. | The safety population (SAF) included all participants enrolled in the study that received the study treatment with data available at the time frame indicated. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/ml) | 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operatively. |
|
|
|
| Secondary | Harris Hip Score (HHS) - Investigational Hard-on-Hard Total Hip Replacement Device Only | The Harris Hip Score (HHS), which ranges from 0 (worst) to 100 (best), considers information on pain, function, and range of motion. HHS was measured for Investigational Hard-on-Hard Total Hip Replacement Device only. | The Intent to Treat (ITT) population included participants enrolled in the study with data available at the time frame indicated. The ITT did not include those that only provided retrospective data, therefore only data for the Investigational Hard-on-Hard Total Hip Replacement Device group was collected. | Posted | Mean | Standard Deviation | score on a scale | Preoperatively, 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operatively. |
|
|
|
| Secondary | Hip Disability and Osteoarthritis Outcome Scores (HOOS) | The Hip Disability and Osteoarthritis Outcome Scores (HOOS) was measured for Investigational Hard-on-Hard Total Hip Replacement Device only and included 40 items with five responses from five subcategories of Pain, Symptoms and Stiffness, Activities of Daily Living, Function in Sports and Recreational Activities, and Quality of Life to produce a total HOOS. The total HOOS scale ranged from 0 to 100, with 0 indicating the worst possible score and 100 indicating the best possible score. | The Intent to Treat (ITT) population included participants enrolled in the study with data available at the time frame indicated. The ITT did not include those that only provided retrospective data, therefore only data for the Investigational Hard-on-Hard Total Hip Replacement Device group was collected. | Posted | Mean | Standard Deviation | score on a scale | Preoperatively, 3 months, 6 months, 1 year, 2 years, 5 years, 7 years, 10 years |
|
|
|
| Secondary | Radiographic Measures: Radiolucencies | Radiolucencies determined by number of participants with occurrence of radiolucent lines and osteolysis (Yes/No) | The safety population (SAF) included all participants enrolled in the study that received the study treatment with data available at the time frame indicated. Data was not collected for the control total hip replacement device group at 3 months, 6 months, 1 year, and 2 years. | Posted | Count of Participants | Participants | 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative |
|
|
|
| Secondary | Radiographic Measures: Heterotopic Ossification | Occurrence of Heterotopic Ossification in participants (Yes/No) | The safety population (SAF) included all participants enrolled in the study that received the study treatment with data available at the time frame indicated. Data was not collected for the control total hip replacement device group at 3 months, 6 months, 1 year, and 2 years. | Posted | Count of Participants | Participants | 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative |
|
|
|
| Secondary | Radiographic Measures: Subsidence | Occurrence of Subsidence in Investigational Hard-on-Hard Total Hip Replacement Device participants (Yes/No) categorized by:
| The safety population (SAF) included all participants enrolled in the study that received the study treatment with data available at the time frame indicated. The safety population (SAF) included all participants enrolled in the study that received the study treatment with data available at the time frame indicated. Data was not collected for the control total hip replacement device group at 3 months, 6 months, 1 year, and 2 years. | Posted | Count of Participants | Participants | 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative |
|
|
|
| Secondary | Health Economic Outcomes: Surgical Blood Loss | Blood loss during surgery measured in milliliters (ml) of blood | The safety population (SAF) included all participants enrolled in the study that received the study treatment with data available at the time frame indicated. | Posted | Mean | Standard Deviation | milliliters (mL) | Intra-operative, up to 50 minutes |
|
|
|
| Secondary | Health Economic Outcomes: Length of Hospital Stay | Length of stay measured by number of days spent in hospital | Length of hospital stay data was not collected as part of the 10 year extension study. | Posted | Hospital admission to discharge |
|
|
| Secondary | Health Economic Outcomes: Operative Time | Operative time in minutes from first incision into skin to time when last suture is applied for the Investigational Hard-on-Hard Total Hip Replacement Device group only | The Intent to Treat (ITT) population included participants enrolled in the study with data available at the time frame indicated. The ITT did not include those that only provided retrospective data, therefore only data for the Investigational Hard-on-Hard Total Hip Replacement Device group was collected. | Posted | Mean | Standard Deviation | Minutes | Intra-operative |
|
|
|
| Secondary | Health Economic Outcomes: Re-Hospitalizations | Re-hospitalizations measured by the number of re-admissions to hospital | Re-hospitalizations data was not collected as part of the 10 year extension study. | Posted | Up to 10 years |
|
|
| 2 |
| 20 |
| 9 |
| 20 |
| 20 |
| 20 |
| EG001 | Control Total Hip Replacement Device | Total Hip replacement surgery using control device consisting of a hard-on-soft bearing or a ceramic-on-ceramic bearing which includes:
| 1 | 6 | 3 | 6 | 6 | 6 |
| Uncontrolled Hypertension | Cardiac disorders | Systematic Assessment |
|
| Death from unknown cause | General disorders | Systematic Assessment | Death from unknown cause |
|
| Contralateral hip replacement | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| left shoulder Rotator cuff tear | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Irritable Bowel Syndrome | Gastrointestinal disorders | Systematic Assessment |
|
| Depression and psychosomatic disorder | Psychiatric disorders | Systematic Assessment |
|
| Gastroscopy and biopsy | Gastrointestinal disorders | Systematic Assessment |
|
| Worsening of prior muscle spasm and pain in study hip | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
|
| Death | General disorders | Systematic Assessment | Death by suicide |
|
| Bilateral inguinal hernia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Anterior right hip dislocation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Osteoarthritis left ankle | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Osteoarthritis effusion left knee | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Right shoulder rotator cuff tear | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Loosening of implant stem | Musculoskeletal and connective tissue disorders | Systematic Assessment | Serious Adverse Device event |
|
| Fall onto right hip (replacement hip) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Breast augmentation surgery | Surgical and medical procedures | Systematic Assessment |
|
| Surgery left foot | Surgical and medical procedures | Systematic Assessment |
|
| Sacroilliac joint pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Sacroilliac joint pain treatment | Surgical and medical procedures | Systematic Assessment |
|
| Haemorrhoids resulting in surgery | Vascular disorders | Systematic Assessment |
|
| Death | Cardiac disorders | Systematic Assessment | Death due to atrial fibrillation and aorta collapse |
|
| Hysterectomy | Reproductive system and breast disorders | Systematic Assessment |
|
| Increased Nickel Levels | Blood and lymphatic system disorders | Systematic Assessment |
|
| Increased Titanium Levels | Blood and lymphatic system disorders | Systematic Assessment |
|
| Increased Cobalt Levels | Blood and lymphatic system disorders | Systematic Assessment |
|
| Increased Chromium Levels | Blood and lymphatic system disorders | Systematic Assessment |
|
| Increased Niobium Levels | Blood and lymphatic system disorders | Systematic Assessment |
|
| Rash at operative site | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Greater trochanter bursitis R hip | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Intermittent back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Osteoarthritis left hip | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain and noise in right hip | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Benign prostate hyperplasia | Reproductive system and breast disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Hypotension | Cardiac disorders | Systematic Assessment |
|
| Rash on back | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Gout | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hip noise | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment | Subject works on farm - injury prone |
|
| Chest pain and shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Right knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Femoral nerve impingement right leg | Nervous system disorders | Systematic Assessment |
|
| Low oxygen levels | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sacroilliac pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Left tennis elbow | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Surgery-left foot | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Diabetes - new | Endocrine disorders | Systematic Assessment |
|
| Polyuria and hematuria | Renal and urinary disorders | Systematic Assessment |
|
| Vomitting | Gastrointestinal disorders | Systematic Assessment |
|
| Kidney stones | Renal and urinary disorders | Systematic Assessment |
|
| Pain in operative hip | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle spasm | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Rash - jugular | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Peripheral neuropathy | Nervous system disorders | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
|
| Surgical site reaction | Infections and infestations | Systematic Assessment |
|
| Perineal nerve weakness left foot | Nervous system disorders | Systematic Assessment |
|
| rash - left foot | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Swelling below left fibular head | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Urine retention after catheter removal | Renal and urinary disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Gastroscopy | Gastrointestinal disorders | Systematic Assessment |
|
| Muscle spasm | Musculoskeletal and connective tissue disorders | Systematic Assessment | location not specified |
|
| Severe depression | Psychiatric disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Urine retention - unknown cause | Renal and urinary disorders | Systematic Assessment |
|
| Trochanter bursitis left hip | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fall on operative hip | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Rash on upper right arm | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Fall on contralateral hip | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
| Cobalt (Co) Concentration in Whole Blood - 6 Months |
|
|
| Cobalt (Co) Concentration in Whole Blood - 1 Year |
|
|
| Cobalt (Co) Concentration in Whole Blood - 2 Years |
|
|
| Cobalt (Co) Concentration in Whole Blood - 5 Years |
|
|
| Cobalt (Co) Concentration in Whole Blood - 7 Years |
|
|
| Cobalt (Co) Concentration in Whole Blood -10 Years |
|
|
| Chromium (Cr) Concentration in Whole Blood - 3 Months |
|
|
| Chromium (Cr) Concentration in Whole Blood - 6 Months |
|
|
| Chromium (Cr) Concentration in Whole Blood - 1 Year |
|
|
| Chromium (Cr) Concentration in Whole Blood - 2 Years |
|
|
| Chromium (Cr) Concentration in Whole Blood - 5 Years |
|
|
| Chromium (Cr) Concentration in Whole Blood - 7 Years |
|
|
| Chromium (Cr) Concentration in Whole Blood - 10 Years |
|
|
| Nickel (Ni) Concentration in Whole Blood - 3 Months |
|
|
| Nickel (Ni) Concentration in Whole Blood - 6 Months |
|
|
| Nickel (Ni) Concentration in Whole Blood - 1 Year |
|
|
| Nickel (Ni) Concentration in Whole Blood - 2 Years |
|
|
| Nickel (Ni) Concentration in Whole Blood - 5 Years |
|
|
| Nickel (Ni) Concentration in Whole Blood - 7 Years |
|
|
| Nickel (Ni) Concentration in Whole Blood - 10 Years |
|
|
| Titanium (Ti) Concentration in Whole Blood - 3 Months |
|
|
| Titanium (Ti) Concentration in Whole Blood - 6 Months |
|
|
| Titanium (Ti) Concentration in Whole Blood - 1 Year |
|
|
| Titanium (Ti) Concentration in Whole Blood - 2 Years |
|
|
| Titanium (Ti) Concentration in Whole Blood - 5 Years |
|
|
| Titanium (Ti) Concentration in Whole Blood - 7 Years |
|
|
| Titanium (Ti) Concentration in Whole Blood - 10 Years |
|
|
| Zirconium (Zr) Concentration in Whole Blood - 3 Months |
|
|
| Zirconium (Zr) Concentration in Whole Blood - 6 Months |
|
|
| Zirconium (Zr) Concentration in Whole Blood - 1 Year |
|
|
| Zirconium (Zr) Concentration in Whole Blood - 2 Years |
|
|
| Zirconium (Zr) Concentration in Whole Blood - 5 Years |
|
|
| Zirconium (Zr) Concentration in Whole Blood - 7 Years |
|
|
| Zirconium (Zr) Concentration in Whole Blood - 10 Years |
|
|
| Niobium (Nb) Concentration in Whole Blood - 3 Months |
|
|
| Niobium (Nb) Concentration in Whole Blood - 6 Months |
|
|
| Niobium (Nb) Concentration in Whole Blood - 1 Year |
|
|
| Niobium (Nb) Concentration in Whole Blood - 2 Years |
|
|
| Niobium (Nb) Concentration in Whole Blood - 5 Years |
|
|
| Niobium (Nb) Concentration in Whole Blood - 7 Years |
|
|
| Niobium (Nb) Concentration in Whole Blood - 10 Years |
|
|
| Molybdenum (Mo) Concentration in Whole Blood - 3 Months |
|
|
| Molybdenum (Mo) Concentration in Whole Blood - 6 Months |
|
|
| Molybdenum (Mo) Concentration in Whole Blood - 1 Year |
|
|
| Molybdenum (Mo) Concentration in Whole Blood - 2 Years |
|
|
| Molybdenum (Mo) Concentration in Whole Blood - 5 Years |
|
|
| Molybdenum (Mo) Concentration in Whole Blood - 7 Years |
|
|
| Molybdenum (Mo) Concentration in Whole Blood - 10 Years |
|
|
| Vanadium (V) Concentration in Whole Blood - 3 Months |
|
|
| Vanadium (V) Concentration in Whole Blood - 6 Months |
|
|
| Vanadium (V) Concentration in Whole Blood - 1 Year |
|
|
| Vanadium (V) Concentration in Whole Blood - 2 Years |
|
|
| Vanadium (V) Concentration in Whole Blood - 5 Years |
|
|
| Vanadium (V) Concentration in Whole Blood - 7 Years |
|
|
| Vanadium (V) Concentration in Whole Blood - 10 Years |
|
|
| Aluminum (Al) Concentration in Whole Blood - 3 Months |
|
|
| Aluminum (Al) Concentration in Whole Blood - 6 Months |
|
|
| Aluminum (Al) Concentration in Whole Blood - 1 Year |
|
|
| Aluminum (Al) Concentration in Whole Blood - 2 Years |
|
|
| Aluminum (Al) Concentration in Whole Blood - 5 Years |
|
|
| Aluminum (Al) Concentration in Whole Blood - 7 Years |
|
|
| Aluminum (Al) Concentration in Whole Blood - 10 Years |
|
|
|
| 6 Months |
|
|
| 1 Year |
|
|
| 2 Years |
|
|
| 5 Years |
|
|
| 7 Years |
|
|
| 10 Years |
|
|
|
| 6 Months |
|
|
| 1 Year |
|
|
| 2 Years |
|
|
| 5 Years |
|
|
| 7 Years |
|
|
| 10 Years |
|
|
| Yes |
|
| Osteolysis - 3 months |
|
|
| Radiolucent Line - 6 months |
|
|
| Osteolysis - 6 months |
|
|
| Radiolucent Line - 1 Year |
|
|
| Osteolysis - 1 Year |
|
|
| Radiolucent Line - 2 Years |
|
|
| Osteolysis - 2 Years |
|
|
| Radiolucent Line - 5 Years |
|
|
| Osteolysis - 5 Years |
|
|
| Radiolucent Line - 7 Years |
|
|
| Osteolysis - 7 Years |
|
|
| Radiolucent Line - 10 Years |
|
|
| Osteolysis - 10 Years |
|
|
| Heterotopic Ossification Grade 1 |
|
| Heterotopic Ossification Grade 2 |
|
| Heterotopic Ossification Grade 3 |
|
| Heterotopic Ossification Grade 4 |
|
| Heterotopic Ossification - 6 Months |
|
|
| Heterotopic Ossification - 1 Year |
|
|
| Heterotopic Ossification - 2 Years |
|
|
| Heterotopic Ossification - 5 Years |
|
|
| Heterotopic Ossification - 7 Years |
|
|
| Heterotopic Ossification - 10 Years |
|
|
| Yes |
|
| Stem Subsidence - 3 months |
|
|
| Evidence of cortical thickening - 3 Months |
|
|
| Acetabular component fail - 3 Months |
|
|
| Femoral component fail - 3 Months |
|
|
| Other - 3 Months |
|
|
| Acetabular Cup Subsidence - 6 months |
|
|
| Stem Subsidence - 6 Months |
|
|
| Evidence of cortical thickening - 6 Months |
|
|
| Acetabular component fail - 6 Months |
|
|
| Femoral component fail - 6 Months |
|
|
| Other- 6 Months |
|
|
| Acetabular Cup Subsidence - 1 Year |
|
|
| Stem Subsidence - 1 Year |
|
|
| Evidence of cortical thickening - 1 Year |
|
|
| Acetabular component fail - 1 Year |
|
|
| Femoral component fail - 1 Year |
|
|
| Other - 1 Year |
|
|
| Acetabular Cup Subsidence - 2 Years |
|
|
| Stem Subsidence 2 Years |
|
|
| Evidence of cortical thickening - 2 Years |
|
|
| Acetabular component fail - 2 Years |
|
|
| Femoral component fail - 2 Years |
|
|
| Other - 2 Years |
|
|
| Acetabular Cup Subsidence - 5 Years |
|
|
| Stem Subsidence - 5 Years |
|
|
| Evidence of cortical thickening - 5 Years |
|
|
| Acetabular component fail - 5 Years |
|
|
| Femoral component fail - 5 Years |
|
|
| Other - 5 Years |
|
|
| Acetabular Cup Subsidence - 7 Years |
|
|
| Stem Subsidence - 7 Years |
|
|
| Evidence of cortical thickening - 7 Years |
|
|
| Acetabular component fail - 7 Years |
|
|
| Femoral component fail - 7 Years |
|
|
| Other - 7 Years |
|
|
| Acetabular Cup Subsidence - 10 Years |
|
|
| Stem Subsidence - 10 Years |
|
|
| Evidence of cortical thickening - 10 Years |
|
|
| Acetabular component fail - 10 Years |
|
|
| Femoral component fail - 10 Years |
|
|
| Other - 10 Years |
|
|