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| Name | Class |
|---|---|
| eResearchTechnology, Inc | INDUSTRY |
| M Squared Associates, Inc. | INDUSTRY |
| ExecuPharm PAREXEL | INDUSTRY |
| IQVIA Pty Ltd |
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The purpose of this prospective, multicenter, single arm study is to confirm the long-term safety and effectiveness of the R3 delta Ceramic Acetabular System PMA (P150030) by evaluating long-term (10 years after surgery) follow-up results.
This PAS is a long-term follow-up of the R3 delta Ceramic Acetabular System (DOD) hips enrolled in the study that was analyzed for the Premarket Approval Application (PMA) Study. The PMA Study analyzed 3 Year postoperative follow-up data on Biolox delta ceramic-on-Biolox delta ceramic (DOD) and Oxidized zirconium-on-Crosslinked Polyethylene (OxZr/XLPE) hips, enrolled and followed in a European Post-market Study ("A prospective, multicenter, non-randomized, clinical outcome study of the R3 Acetabular System in patients with degenerative hip disease").
The purpose of this prospective, multicenter, single arm study is to confirm the long-term safety and effectiveness of the R3 delta Ceramic Acetabular System PMA (P150030) by evaluating long-term (10 years after surgery) follow-up results. Hips are evaluated at the following intervals: 5, 7, 10 years postoperative. The primary study endpoint is implant survivorship at 10 years post surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post Approval Study | The PAS cohort consisted of 137 subjects who were implanted with the R3 delta Ceramic Acetabular System (DoD) in the pivotal study. These patients will continue to be followed to 10 years post-operatively. The primary endpoint for the PAS study is implant survivorship at 10 years post study procedure. |
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| Measure | Description | Time Frame |
|---|---|---|
| Implant Survivorship | Number of participants hip implant survivorship with implant survival defined as no revision through 10 years (i.e., 'Hip Survived' or 'Hip Did Not Survive'). | 10 Years |
| Measure | Description | Time Frame |
|---|---|---|
| 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-years, 5-years, 7-years, 10-years |
| Number of Participants With Radiographic Success |
Not provided
Inclusion Criteria:
Patient is 18-75 years old and he/she is skeletally mature
Exclusion Criteria:
Patient has active infection or sepsis (treated or untreated)
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Nikolaas | Sint-Niklaas | Belgium | ||||
| HUS Peijaksen sairaala, Ortopedia ja traumatologia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33422084 | Derived | Davis ET, Remes V, Virolainen P, Gebuhr P, Van Backle B, Revell MP, Kopjar B. Mid-term outcomes of the R3 delta ceramic acetabular system in total hip arthroplasty. J Orthop Surg Res. 2021 Jan 9;16(1):35. doi: 10.1186/s13018-020-02192-6. |
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Participants previously recruited & enrolled in the post-market approval (PMA) were considered enrolled in this post-approval study (PAS). Additional consent was not required (reviewed and approved by study sites' ethic committees) because the participants had existing consent from the PMA agreeing to be followed to the 10-year postoperative interval necessary for this PAS.
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| ID | Title | Description |
|---|---|---|
| FG000 | Post Approval Study | Participants implanted with the R3 delta Ceramic Acetabular System (DoD) in the pivotal study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Post Approval Study | Participants implanted with the R3 delta Ceramic Acetabular System (DoD) in the pivotal study. |
| 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 | Number of participants hip implant survivorship with implant survival defined as no revision through 10 years (i.e., 'Hip Survived' or 'Hip Did Not Survive'). | Participants with any data available at the time frame specified | Posted | Count of Participants | Participants | 10 Years |
|
|
Adverse Events were collected following implantation of the R3 delta Ceramic Acetabular System (DoD) 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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Post Approval Study | Participants implanted with the R3 delta Ceramic Acetabular System (DoD) in the pivotal study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aseptic implant (acetabular cup) loosening right hip | Product Issues | Systematic Assessment | Related to device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | Systematic Assessment | Unrelated |
At the 10+ Year interval, the follow-up rates that require collection of additional data for the secondary endpoints, ActualA-In-Window and ActualA, are 77.0% and 78.6%, respectively, for all hips. The additional analyses that were done to assess the impact of protocol deviations incurred including those resulting from the COVID-19 pandemic support that the missing data are unlikely to have an impact on the primary or secondary endpoint results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fleur Derdeyn, Principal Clinical Study Manager | Smith + Nephew | 0032 497 60 20 32 | fleur.derdeyn@smith-nephew.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2017 | May 15, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| INDUSTRY |
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Count of participants with radiographic success, where success is defined as:
Participants who did not meet criteria specified above were considered radiographic failures |
| 3-years, 5-years, 7-years 10-years |
| Helsinki |
| 00029 |
| Finland |
| TYKS Turku University Hospital | Turku | 20880 | Finland |
| La Paz Hospital | Madrid | 28046 | Spain |
| The Royal Orthopaedic Hospital, NHS Foundation Trust | Birmingham | B 31 2AP | United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
|
| Secondary | 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. | Participants with data available at time frames specifies | Posted | Mean | Standard Deviation | score on a scale | Pre-operative, 3-years, 5-years, 7-years, 10-years |
|
|
|
| Secondary | Number of Participants With Radiographic Success | Count of participants with radiographic success, where success is defined as:
Participants who did not meet criteria specified above were considered radiographic failures | Number of participants with any data available for the time frame specified | Posted | Count of Participants | Participants | 3-years, 5-years, 7-years 10-years |
|
|
|
| 7 |
| 135 |
| 83 |
| 135 |
| 99 |
| 135 |
|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Unrelated |
|
| Cervix cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Unrelated |
|
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Unrelated |
|
| Goiter adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Unrelated |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Unrelated |
|
| Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Unrelated |
|
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Unrelated |
|
| Basal cel carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Unrelated |
|
| Mesothelium cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Unrelated |
|
| Bronchus/lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Unrelated |
|
| Rectal/colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Unrelated |
|
| Artery sclerosis | Cardiac disorders | Systematic Assessment | Unrelated |
|
| Cardiac arrhytmia | Cardiac disorders | Systematic Assessment | Unrelated |
|
| Cerebrovascular infarction | Cardiac disorders | Systematic Assessment | Unrelated |
|
| Deep vein trombosis | Cardiac disorders | Systematic Assessment | Unrelated |
|
| Congestive heart failure descompensation | Cardiac disorders | Systematic Assessment | Unrelated |
|
| Hypertension | Cardiac disorders | Systematic Assessment | Unrelated |
|
| Insufficienty mitral valve | Cardiac disorders | Systematic Assessment | Unrelated |
|
| Takotsubo cardiomyopathy | Cardiac disorders | Systematic Assessment | Unrelated |
|
| TIA | Cardiac disorders | Systematic Assessment | Unrelated |
|
| Stroke | Cardiac disorders | Systematic Assessment | Unrelated |
|
| Death | General disorders | Systematic Assessment | Unrelated |
|
| Abcess | Gastrointestinal disorders | Systematic Assessment | Unrelated |
|
| Appendicitis | Gastrointestinal disorders | Systematic Assessment | Unrelated |
|
| Cholecystitis | Gastrointestinal disorders | Systematic Assessment | Unrelated |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment | Unrelated |
|
| Diverticulosis | Gastrointestinal disorders | Systematic Assessment | Unrelated |
|
| Fistel | Gastrointestinal disorders | Systematic Assessment | Unrelated |
|
| Gastro-intestinal bleeding | Gastrointestinal disorders | Systematic Assessment | Unrelated |
|
| Hernia Inguinalis | Gastrointestinal disorders | Systematic Assessment | Unrelated |
|
| Rectosigmoidoal polyp | Gastrointestinal disorders | Systematic Assessment | Unrelated |
|
| Stomach perforation | Gastrointestinal disorders | Systematic Assessment | Unrelated |
|
| Abdominal pain due to dehydration | Endocrine disorders | Systematic Assessment | Unrelated |
|
| Diabetes | Endocrine disorders | Systematic Assessment | Unrelated |
|
| Acute liver failure | Endocrine disorders | Systematic Assessment | Unrelated |
|
| Multinodular goiter | Endocrine disorders | Systematic Assessment | Unrelated |
|
| Liver cirrosis | Endocrine disorders | Systematic Assessment | Unrelated |
|
| Pancreatitis | Endocrine disorders | Systematic Assessment | Unrelated |
|
| Blepharochalasis | Eye disorders | Systematic Assessment | Unrelated |
|
| Cataract | Eye disorders | Systematic Assessment | Unrelated |
|
| Degeneration | Eye disorders | Systematic Assessment | Unrelated |
|
| Subluxation eye lens | Eye disorders | Systematic Assessment | Unrelated |
|
| Hypokaliemia | Immune system disorders | Systematic Assessment | Unrelated |
|
| Surgical wound infection | Infections and infestations | Systematic Assessment | Unrelated |
|
| Sepsis | Infections and infestations | Systematic Assessment | Unrelated |
|
| Induced coma due to road traffic accident | Injury, poisoning and procedural complications | Systematic Assessment | Unrelated |
|
| Pelvic fracture due to a fall | Injury, poisoning and procedural complications | Systematic Assessment | Unrelated |
|
| Wound head due to a fall | Injury, poisoning and procedural complications | Systematic Assessment | Unrelated |
|
| Wound in face | Injury, poisoning and procedural complications | Systematic Assessment | Unrelated |
|
| Leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Related to device |
|
| Alzheimer | Psychiatric disorders | Systematic Assessment | Unrelated |
|
| Depression | Psychiatric disorders | Systematic Assessment | Unrelated |
|
| Stress (extreme) | Psychiatric disorders | Systematic Assessment | Unrelated |
|
| Swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Achilles tendon rupture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Meniscus tear | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Muscle tear | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Tendon rupture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Disc prolapse | Nervous system disorders | Systematic Assessment | Unrelated |
|
| Carpal tunnel syndrome right | Nervous system disorders | Systematic Assessment | Unrelated |
|
| Commotio cerebri | Nervous system disorders | Systematic Assessment | Unrelated |
|
| Leuco-encefalopathy | Nervous system disorders | Systematic Assessment | Unrelated |
|
| Corticosubcorticale atrophy | Nervous system disorders | Systematic Assessment | Unrelated |
|
| Polyneuropathy | Nervous system disorders | Systematic Assessment | Unrelated |
|
| Pain left hip due to a fall | General disorders | Systematic Assessment | Unrelated |
|
| Worsening of the polyethylene liner wear + hip left side | General disorders | Systematic Assessment | Unrelated |
|
| Hysterocele | Reproductive system and breast disorders | Systematic Assessment | Unrelated |
|
| Benigne prostate hypertrophy | Reproductive system and breast disorders | Systematic Assessment | Unrelated |
|
| Epidydimitis | Reproductive system and breast disorders | Systematic Assessment | Unrelated |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Unrelated |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Unrelated |
|
| COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Unrelated |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Unrelated |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Unrelated |
|
| Lung oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Unrelated |
|
| Pleura fluid | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Unrelated |
|
| Lung embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Unrelated |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Unrelated |
|
| Respiratory sepsis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Unrelated |
|
| Respiratory insuficience | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Unrelated |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Unrelated |
|
| Acetabular component loosening | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Arthrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| broken tooth | General disorders | Systematic Assessment | Unrelated |
|
| Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Contusio | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Foot Surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Hernia | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Impingement | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Labral tear | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Spinal stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Trigger finger | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Revision surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Wound | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Folliculitis | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Ingrown toenail | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Laceration | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Correction abdominal wall | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Headache, right eye visual symptoms for unknown reason | General disorders | Systematic Assessment | Unrelated |
|
| Hiccup | General disorders | Systematic Assessment | Unrelated |
|
| Acute Kidney failure | Renal and urinary disorders | Systematic Assessment | Unrelated |
|
| Hydro-uretronetrosis | Renal and urinary disorders | Systematic Assessment | Unrelated |
|
| Hematurie | Renal and urinary disorders | Systematic Assessment | Unrelated |
|
| Chronic Kidney failure | Renal and urinary disorders | Systematic Assessment | Unrelated |
|
| Hydrometrose | Renal and urinary disorders | Systematic Assessment | Unrelated |
|
| Renal insufficiency | Renal and urinary disorders | Systematic Assessment | Unrelated |
|
| Subnephrotic proteinaria due to her nephropathy | Renal and urinary disorders | Systematic Assessment | Unrelated |
|
| Claudication | Vascular disorders | Systematic Assessment | Unrelated |
|
| Diverticulitis aorta | Vascular disorders | Systematic Assessment | Unrelated |
|
| Chronic venous insufficiency | Vascular disorders | Systematic Assessment | Unrelated |
|
| Syncope | Vascular disorders | Systematic Assessment | Unrelated |
|
| Aneurysma | Vascular disorders | Systematic Assessment | Unrelated |
|
| AV-block Grade I | Vascular disorders | Systematic Assessment | Unrelated |
|
| Artery sclerosis | Vascular disorders | Systematic Assessment | Unrelated |
|
| Cardiac arrhytmia | Vascular disorders | Systematic Assessment | Unrelated |
|
| Deep vein trombosis | Vascular disorders | Systematic Assessment | Unrelated |
|
| Sinnus of arterial insufficiency | Vascular disorders | Systematic Assessment | Unrelated |
|
| Peripheral arterial disease | Vascular disorders | Systematic Assessment | Unrelated |
|
| Headache | Vascular disorders | Systematic Assessment | Unrelated |
|
| Multiple brain ischemia chronic | Vascular disorders | Systematic Assessment | Unrelated |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment | Unrelated |
|
| Hemorrhagia Ex Ano | Gastrointestinal disorders | Systematic Assessment | Unrelated |
|
| Fecal incontinence | Gastrointestinal disorders | Systematic Assessment | Unrelated |
|
| Diverticulitis | Gastrointestinal disorders | Systematic Assessment | Unrelated |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Unrelated |
|
| Hemorrhoids | Gastrointestinal disorders | Systematic Assessment | Unrelated |
|
| Anal swelling | Gastrointestinal disorders | Systematic Assessment | Unrelated |
|
| Pyrosis | Gastrointestinal disorders | Systematic Assessment | Unrelated |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment | Unrelated |
|
| Gastric pain | Gastrointestinal disorders | Systematic Assessment | Unrelated |
|
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment | Unrelated |
|
| Otitis externa | Ear and labyrinth disorders | Systematic Assessment | Unrelated |
|
| Hearing impairment | Ear and labyrinth disorders | Systematic Assessment | Unrelated |
|
| Vertigo | Ear and labyrinth disorders | Systematic Assessment | Unrelated |
|
| Tube dysfunction | Ear and labyrinth disorders | Systematic Assessment | Unrelated |
|
| Cholelithiasis | Endocrine disorders | Systematic Assessment | Unrelated |
|
| Hypovitaminosis | Endocrine disorders | Systematic Assessment | Unrelated |
|
| Gout | Endocrine disorders | Systematic Assessment | Unrelated |
|
| Liver steatosis | Endocrine disorders | Systematic Assessment | Unrelated |
|
| Hypercholesterolemia | Endocrine disorders | Systematic Assessment | Unrelated |
|
| Cholecystalithiosis | Endocrine disorders | Systematic Assessment | Unrelated |
|
| Enlarged thyroid gland | Endocrine disorders | Systematic Assessment | Unrelated |
|
| Cataract | Eye disorders | Systematic Assessment | Unrelated |
|
| Retinal rupture | Eye disorders | Systematic Assessment | Unrelated |
|
| PCO | Eye disorders | Systematic Assessment | Unrelated |
|
| Groin pain due to tendinopathy | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Deteriorating pain in groin right hip | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device related |
|
| Slightly higher CRP | Immune system disorders | Systematic Assessment | Unrelated |
|
| Rheuma | Immune system disorders | Systematic Assessment | Unrelated |
|
| Heterotopic ossification of hip seen on xray | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device related |
|
| Peri-articular ossification | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Worsening of peri-articular ossification | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Discomfort lateral aspect hip | General disorders | Systematic Assessment | Device related |
|
| Occasional mild discomfort in groin and hip | General disorders | Systematic Assessment | Device related |
|
| Cellulitis | Infections and infestations | Systematic Assessment | Unrelated |
|
| Herpes | Infections and infestations | Systematic Assessment | Unrelated |
|
| Infection surgical wound | Infections and infestations | Systematic Assessment | Unrelated |
|
| Flu | Infections and infestations | Systematic Assessment | Unrelated |
|
| Patient fell down | Injury, poisoning and procedural complications | Systematic Assessment | Unrelated |
|
| Allergic reaction (food) | Injury, poisoning and procedural complications | Systematic Assessment | Unrelated |
|
| Dementia | Psychiatric disorders | Systematic Assessment | Unrelated |
|
| Depression | Psychiatric disorders | Systematic Assessment | Unrelated |
|
| Memory decline | Psychiatric disorders | Systematic Assessment | Unrelated |
|
| Anxiety | Psychiatric disorders | Systematic Assessment | Unrelated |
|
| Oedema legs | Blood and lymphatic system disorders | Systematic Assessment | Unrelated |
|
| Bursitis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Chondrocalcinosis menisci | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Elastofibroma | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Inflammation bursa iliopsoas | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Fibrostosis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Impingement | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Infection tendon | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| muscular reumatism | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Muscle weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Muscle tear | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Menisci tears | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Rupture tendon | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Sprain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Symphysitis of pubis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Tendinopathy | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Tendinitis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Tendinosis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Tendostosis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Trochanteric bursitis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Tennis elbow | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Trochanteritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Radicular pain in lower extremity (Ischias) | Nervous system disorders | Systematic Assessment | Unrelated |
|
| Sleep apnea | Nervous system disorders | Systematic Assessment | Unrelated |
|
| Neuropatic pain | Nervous system disorders | Systematic Assessment | Unrelated |
|
| Horner syndrome | Nervous system disorders | Systematic Assessment | Unrelated |
|
| Dizziness cervical origin | Nervous system disorders | Systematic Assessment | Unrelated |
|
| Unexplained bruising on lower left calf | General disorders | Systematic Assessment | Unrelated |
|
| Afonia | General disorders | Systematic Assessment | Unrelated |
|
| Fever and color wound right leg | General disorders | Systematic Assessment | Unrelated |
|
| Fever | General disorders | Systematic Assessment | Unrelated |
|
| Unexplained pain of operated hip | General disorders | Systematic Assessment | Device related |
|
| Pain | General disorders | Systematic Assessment | Device related |
|
| Iliopsoas bursitis | General disorders | Systematic Assessment | Device related |
|
| Pain | General disorders | Systematic Assessment | Unrelated |
|
| Chest pain | General disorders | Systematic Assessment | Unrelated |
|
| Headache | General disorders | Systematic Assessment | Unrelated |
|
| Pain in hip | General disorders | Systematic Assessment | Unrelated |
|
| Breast pain | General disorders | Systematic Assessment | Unrelated |
|
| Adverse reaction to metal debris | Product Issues | Systematic Assessment | Device related |
|
| Prostatitis | Reproductive system and breast disorders | Systematic Assessment | Unrelated |
|
| Benigne prostate hypertrophy | Reproductive system and breast disorders | Systematic Assessment | Unrelated |
|
| Epydimitis left testes | Reproductive system and breast disorders | Systematic Assessment | Unrelated |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Unrelated |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Unrelated |
|
| Dyspnoe | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Unrelated |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Unrelated |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Unrelated |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Unrelated |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Arthrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Capsular irritation around left hip and groin pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Cervicalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Cervicobrachialgie | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Chondromalacie | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Contusion | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Discopathy | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Cyst | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Dupuytren dig 5 right hand | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Hallux rigidus | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Hallux Valgus | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Heel spur | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Lumbalgie | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| osteoporosis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Painful metatarsophalangeal joint | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Pain in hip | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Ankle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Cervical pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Pain in foot | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Peri-articular ossification | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Pins and needles left leg | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device related |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Spinal stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Cervical vertebrae stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Trochanteritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device related |
|
| Active keratosis | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Solar Keratosis | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Eczema | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Dermatochalasis | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Actinic keratosis | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Exostosis in the heel | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Wound on left hip - along previous surgery wound | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Wound right knee and lower leg due to a fall | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Erythema due to bites of insects | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Removal birthmark nose | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Skin tear left arm due to a fall | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Cut left little finger | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Panniculitis right knee | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Wound left index finger | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Subunguaal hematoma right finger (3) | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Wound nose due to a fall | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Psoriasis | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Seborrheic keratosis irritation | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Keratosis actinica | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Prolonged chest pain | General disorders | Systematic Assessment | Unrelated |
|
| Intermittent flare ups of neck pain and right arm pain | General disorders | Systematic Assessment | Unrelated |
|
| Slight stiffness in right hip | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device related |
|
| Benigne paroxysmale positionings vertigo (BPPV) | Ear and labyrinth disorders | Systematic Assessment | Unrelated |
|
| Trochanteritis right hip | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment | Unrelated |
|
| Cystitis acute | Renal and urinary disorders | Systematic Assessment | Unrelated |
|
| Ovarium cyste | Renal and urinary disorders | Systematic Assessment | Unrelated |
|
| Prostate hypertrophy | Renal and urinary disorders | Systematic Assessment | Unrelated |
|
| Haematuria (asymptomatic) | Renal and urinary disorders | Systematic Assessment | Unrelated |
|
| Benign tumor tonsilla | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Unrelated |
|
| Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Unrelated |
|
| Rectal/colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Unrelated |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Unrelated |
|
| Meningeoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Unrelated |
|
Not provided
| D012216 |
| Rheumatic Diseases |
|
| 5-year |
|
|
| 7-year |
|
|
| 10-year |
|
|
| 5-years |
|
|
| 7-years |
|
|
| 10-years |
|
|