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The Zimmer Hip Resurfacing System Post-Market Clinical Follow-up study will examine the safety and efficacy of this device in the young and/or active patient with advanced hip disease.
This is a multi-center, prospective, non-controlled post market surveillance study. The objective of this study is to obtain survival and outcome data on the Zimmer Hip Resurfacing System. This will be assessed by analysis of standard scoring systems, radiographs and adverse event records. Data will be used to monitor pain, mobility and survivorship, and to confirm the safety and efficacy of the Zimmer Hip Resurfacing System. Serum metal ion levels (cobalt and chromium) will also be collected pre-operatively and again at 6 months, 1 year, 2 years and 5 years. This procedure will offer an option to these patients who would otherwise require and likely outlive a conventional total hip replacement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who received Metasul Monoblock in hip resurfacing | Experimental | Patients who received the Zimmer Hip Resurfacing System utilising the Metasul Monoblock Component Cup in a Hip Resurfacing Application with the Durom Hip Resurfacing Femoral Component and whose Serum metal ion levels is being measured. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serum Metal ion levels determined to monitor changes in chromium and cobalt levels | Diagnostic Test | Analyses was performed pre-operatively, 6 months, 1 year, 2 years and 5 years post-operatively for all study subjects enrolled in this study, as well as, all revision study subjects receiving the Metasul LDH™ total hip system. To prevent intra-observer variation the metal ion concentrations was analysed by an approved Central Laboratory. The Central Laboratory provided specimen collection kits for the transfer of blood specimens to the Laboratory for analysis. The Laboratory provided the results to the Investigators. The cobalt and chromium was measured by induced coupled plasma mass spectrometry (ICP-MS). BUN, creatinine and GFR will be determined locally. |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survival | The primary endpoint for this study is implant survival at 10 years which is assessed by revision of the Metasul Monoblock Component Cup calculated using the Kaplan-Meier Survival Estimation. The survivorship with Kaplan-Meier (K-M) was calculated at 10 year for endpoint revision of any component. | 10 years post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score | The Harris Hip Score (HHS) is an outcome measure that includes a series of questions answered by the patient and physical examinations recorded by a qualified health care professional. The HHS covers four domains: pain, function and functional activities, absence of deformity and range of motion. The total score vary from a range of 0 - 100. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: < 70. |
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Inclusion Criteria:
Patient selection without bias to race or gender.
Patient is ≥ 18 and ≤ 65 years of age.
Female patients only, if
Pre-operative Harris Hip Score ≤ 70.
Primary surgical hip candidate, suffering from hip pain and/or disability due to degenerative joint disease (inflammatory or non-inflammatory), based on physical examination and history, which may include the following diagnosis:
Patient is willing and able to cooperate in prescribed post-operative therapy.
Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
Patient has participated in the Informed Consent process and has signed an Ethics Committee approved Informed Consent.
Exclusion Criteria:
Patient has an acute, chronic, local or systemic infection.
Patient is skeletally immature.
Patient is known to be pregnant.
Patient has a severe muscular, neural or vascular disease that endangers the involved extremity.
Patient has an insufficient acetabular or femoral bone stock in which good anchorage of the implants are unlikely or impossible, including, but not limited to:
Patient has a total or partial absence of the muscular or ligamentous apparatus.
Patient has known moderate to severe renal insufficiency.
Patient has a known clinical condition which may interfere with the patient's outcome, including but not limited to:
Patient is severely overweight (BMI > 40)
Patient is scheduled for simultaneous bilateral total hip replacement.
OPERATIVE (IPSILATERAL) HIP: Patient has a total prosthetic hip replacement device, surface arthroplasty, endoprosthesis or femoral and/or acetabular osteosynthesis.
CONTRALATERAL HIP: Patient has had a hip replacement, surface arthroplasty or endoprosthesis, within the past 12 months, unless previously enrolled in this clinical study.
Patient is:
Patient has participated in a study of any other investigational device (drug, device or biologic) within the past 12 months. Exception: previous enrollment in the Zimmer Hip Resurfacing clinical study.
Patient has a known allergy to one of the constituents of the implant, e.g. cobalt, chromium, nickel, etc.
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| Name | Affiliation | Role |
|---|---|---|
| Hassan Achakri | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Fakultàt Carl Gustav Carus der Technischen Universität Dresden | Dresden | 01307 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Who Received Metasul Monoblock in Hip Resurfacing | Patients who received the Zimmer Hip Resurfacing System utilising the Metasul Monoblock Component™ Cup in a Hip Resurfacing Application with the Durom® Hip Resurfacing Femoral Component and whose Serum metal ion levels is being measured. Serum Metal ion levels determined to monitor changes in chromium and cobalt levels: Analyses will be performed pre-operatively, 6 months, 1 year, 2 years and 5 years postoperatively for all study subjects enrolled in this study, as well as, all revision study subjects receiving the Metasul® LDH™ total hip system. To prevent intra-observer variation the metal ion concentrations will be analysed by an approved Central Laboratory. The Central Laboratory will provide specimen collection kits for the transfer of blood specimens to the Laboratory for analysis. The Laboratory will provide the results to the Investigators. The cobalt and chromium will be measured by induced coupled plasma mass spectrometry (ICP-MS). BUN, creatinine and GFR will be determined locally. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 15, 2012 |
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| Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery |
| Subject Quality-of-life Determined by the SF-12 Questionnaire (Mental Health and Physical Health) | The SF-12 is a multi-purpose short-form (SF) generic measure of health status. It consists of twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH). Scores ranges from 0 to 100, with higher scores indicating better physical and mental health functioning. | Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery |
| Patient's Activity Level Determined by UCLA Score | The UCLA score was a part of the Patient Activity Questionnaire which ascertains the patient's activity level from 1 (low) to 10 (high) in patients undergoing total hip arthroplasty. | Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery |
| Radiographic Evaluation | Radiographic parameters evaluated were radiolucencies, osteolysis, hypertrophy, subsidence, cup migration, change in cup angle and change in femoral shaft angle. The radiographs related to any significant radiographic findings reported by an Investigator were also be assessed by an Independent Radiographic Reviewer. The data presented in the outcome measure data table represent the Number of Participants with Abnormal or Significant Findings during the course of the study. | Pre-op, 6 weeks, 1,2,3,5,7 and 10 years post operatively 2, 3, 5, 7 and 10 years post-operatively. 2, 3, 5, 7 and 10 years post-operatively. |
| EuroQol 5 Dimension (EQ-5D) | The EuroQol 5 Dimension (EQ-5D) is a standardized Instrument widely used to measure health status. It is a self reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes 5 questions referring to mobility, selfcare, daily activities, pain/discomfort, and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. The EQ-5D-5L score ranges from -0.59 to 1, where 1 is the best possible health state. The Visual Analogue Scale (VAS) is a vertical scale ranges from 100 ('The best health you can imagine') to 0 ('The worst health you can imagine') where the patient reports his/her self-rated health. For this study, the VAS score was not calculated. | Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery |
| Oxford Hip Score | The Oxford Hip Score (OHS) is a patient-reported outcome measure that was developed to specifically assess the patient's perspective of outcome following THA. The OHS consists of twelve questions covering function and pain associated with the hip. To calculate the total score, each response is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. Scores ranges from 0 to 100 and the outcome score can be categorized as Excellent: > 41; Good: 34 - 41; Fair: 27 - 33; Poor: < 27. | Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery |
| Pain and Functional Performance Based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | The WOMAC Score is a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip. These set of standardized questions are used by doctors to evaluate the condition of osteoarthritis patients. The WOMAC score was an optional form reported for pain and physical function. The test questions are scored on a scale of 0-4, which correspond to: No pain (0), Mild pain (1), Moderate pain (2), Severe pain (3), and Extreme pain (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain (with higher values representing worse outcomes and lower values representing better outcomes) and 0-68 for Physical Function (with higher values representing better outcomes and lower values representing worse outcomes). | Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Who Received the Zimmer Hip Resurfacing System | The Zimmer Hip Resurfacing System is designed for the treatment of degenerative diseases or trauma of the hip. The system is intended to reduce pain and increase hip mobility. The Zimmer Hip Resurfacing System may be used for the following indications:
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| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | 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 | Count of Participants | Participants |
| ||||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Weight | Mean | Standard Deviation | Kg |
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| Height | Mean | Standard Deviation | Cm |
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| 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 Survival | The primary endpoint for this study is implant survival at 10 years which is assessed by revision of the Metasul Monoblock Component Cup calculated using the Kaplan-Meier Survival Estimation. The survivorship with Kaplan-Meier (K-M) was calculated at 10 year for endpoint revision of any component. | All study patients involved in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | 10 years post-surgery |
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| Secondary | Harris Hip Score | The Harris Hip Score (HHS) is an outcome measure that includes a series of questions answered by the patient and physical examinations recorded by a qualified health care professional. The HHS covers four domains: pain, function and functional activities, absence of deformity and range of motion. The total score vary from a range of 0 - 100. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: < 70. | The mean Harris Hip Score and standard deviation for all study patients is presented in the results section below for all follow up time points. | Posted | Mean | Standard Deviation | score on a scale | Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery |
| |||||||||||||||||||||||||||
| Secondary | Subject Quality-of-life Determined by the SF-12 Questionnaire (Mental Health and Physical Health) | The SF-12 is a multi-purpose short-form (SF) generic measure of health status. It consists of twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH). Scores ranges from 0 to 100, with higher scores indicating better physical and mental health functioning. | The mean and standard deviation for SF-12 physical and mental is presented in the results section below for all follow up time points. | Posted | Mean | Standard Deviation | score on a scale | Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery |
| |||||||||||||||||||||||||||
| Secondary | Patient's Activity Level Determined by UCLA Score | The UCLA score was a part of the Patient Activity Questionnaire which ascertains the patient's activity level from 1 (low) to 10 (high) in patients undergoing total hip arthroplasty. | The mean and standard deviation for UCLA activity score is presented in the results section below for all follow up time points. | Posted | Mean | Standard Deviation | score on a scale | Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery |
| |||||||||||||||||||||||||||
| Secondary | Radiographic Evaluation | Radiographic parameters evaluated were radiolucencies, osteolysis, hypertrophy, subsidence, cup migration, change in cup angle and change in femoral shaft angle. The radiographs related to any significant radiographic findings reported by an Investigator were also be assessed by an Independent Radiographic Reviewer. The data presented in the outcome measure data table represent the Number of Participants with Abnormal or Significant Findings during the course of the study. | The significant radiographic findings reported for all patients during the course of the study is presented in the results section below for all follow up time points of occurrence. | Posted | Number | participants | Pre-op, 6 weeks, 1,2,3,5,7 and 10 years post operatively 2, 3, 5, 7 and 10 years post-operatively. 2, 3, 5, 7 and 10 years post-operatively. |
| ||||||||||||||||||||||||||||
| Secondary | EuroQol 5 Dimension (EQ-5D) | The EuroQol 5 Dimension (EQ-5D) is a standardized Instrument widely used to measure health status. It is a self reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes 5 questions referring to mobility, selfcare, daily activities, pain/discomfort, and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. The EQ-5D-5L score ranges from -0.59 to 1, where 1 is the best possible health state. The Visual Analogue Scale (VAS) is a vertical scale ranges from 100 ('The best health you can imagine') to 0 ('The worst health you can imagine') where the patient reports his/her self-rated health. For this study, the VAS score was not calculated. | The mean and standard deviation for EQ-5D is presented in the results section below for all follow up time points. | Posted | Mean | Standard Deviation | score on a scale | Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery |
| |||||||||||||||||||||||||||
| Secondary | Oxford Hip Score | The Oxford Hip Score (OHS) is a patient-reported outcome measure that was developed to specifically assess the patient's perspective of outcome following THA. The OHS consists of twelve questions covering function and pain associated with the hip. To calculate the total score, each response is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. Scores ranges from 0 to 100 and the outcome score can be categorized as Excellent: > 41; Good: 34 - 41; Fair: 27 - 33; Poor: < 27. | The mean and standard deviation for Oxford Hip Score is presented in the results section below for all follow up time points. | Posted | Mean | Standard Deviation | score on a scale | Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery |
| |||||||||||||||||||||||||||
| Secondary | Pain and Functional Performance Based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | The WOMAC Score is a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip. These set of standardized questions are used by doctors to evaluate the condition of osteoarthritis patients. The WOMAC score was an optional form reported for pain and physical function. The test questions are scored on a scale of 0-4, which correspond to: No pain (0), Mild pain (1), Moderate pain (2), Severe pain (3), and Extreme pain (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain (with higher values representing worse outcomes and lower values representing better outcomes) and 0-68 for Physical Function (with higher values representing better outcomes and lower values representing worse outcomes). | The mean and standard deviation for the WOMAC pain and physical function score is presented in the results section below for all follow up time points. The number of participants analyzed is not consistent with the numbers in the participant flow module because the numbers reported in the participant flow module represents the number of patients with these form completed at the subsequent follow up time points. | Posted | Mean | Standard Deviation | score on a scale | Preop, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery |
|
Operative, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year and 10 years post-surgery
Adverse events were grouped into hip related or general adverse events.
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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 | Patients Who Received Metasul Monoblock in Hip Resurfacing | Patients who received the Zimmer Hip Resurfacing System utilising the Metasul Monoblock Component Cup in a Hip Resurfacing Application with the Durom Hip Resurfacing Femoral Component and whose Serum metal ion levels is being measured. Serum Metal ion levels determined to monitor changes in chromium and cobalt levels: Analyses will be performed pre-operatively, 6 months, 1 year, 2 years and 5 years postoperatively for all study subjects enrolled in this study, as well as, all revision study subjects receiving the Metasul LDH™ total hip system. To prevent intra-observer variation the metal ion concentrations will be analysed by an approved Central Laboratory. The Central Laboratory will provide specimen collection kits for the transfer of blood specimens to the Laboratory for analysis. The Laboratory will provide the results to the Investigators. The cobalt and chromium will be measured by induced coupled plasma mass spectrometry (ICP-MS). BUN, creatinine and GFR will be determined locally. | 4 | 45 | 3 | 45 | 17 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Femoral Neck Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Emergency hospitalization due to a femoral neck fracture |
| |
| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Pain dragging into the groin with a walking distance of 500m |
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| Translucency | Musculoskeletal and connective tissue disorders | Systematic Assessment | Translucency around the left femoral hip stem |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular | Cardiac disorders | Systematic Assessment | Circulatory Failure |
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| Dermatological | Skin and subcutaneous tissue disorders | Systematic Assessment | Erysipelas left tibia and Erysipalas in sore area. |
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| Endocrine | Endocrine disorders | Systematic Assessment | Wide knot in thyroid gland |
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| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment | Norovirus |
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| Hematological | General disorders | Systematic Assessment | Elevated metal ions |
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| Muscoloskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment | Right knee pain |
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| Pulmonary Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Breathlessness |
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| Thigh Groin Hip Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Groin pain |
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| Other General Complications | General disorders | Systematic Assessment | Shoulder surgery |
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| Other General Complications | Surgical and medical procedures | Systematic Assessment | Bursitis on right elbow |
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| Other General Complications | Gastrointestinal disorders | Systematic Assessment | Intestinal inflammation |
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| Other General Complications | Reproductive system and breast disorders | Systematic Assessment | Testicular Hydrocele |
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| Other General Complications | Social circumstances | Systematic Assessment | Fall from bycicle |
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| Dermatological | Skin and subcutaneous tissue disorders | Systematic Assessment | Excema in wound area |
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| Other General Complications | Skin and subcutaneous tissue disorders | Systematic Assessment | Exantherm all over body |
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| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Gluteal and femoral pain on knee joint |
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| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Disc hernia |
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The study devices were taken off the market in 2013.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Esther Foo | Zimmer Biomet | +41792894930 | esther.foo@zimmerbiomet.com |
| Jun 5, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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