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There is no regulatory or otherwise commitment to continue to follow up to the 10-year time point. The study data had met the primary objectives. After a business review, Smith+Nephew had decided to terminate the study prematurely.
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This study will look at the health results of using the LEGIONâ„¢ Primary Knee System over a period of ten (10) years. This type of surgery uses an artificial knee made of plastic and metal. This study will enter subjects who suffer from a variety of conditions that have caused at least one of their knees to become nonfunctional. You are being asked to participate in the study because you have significant problems with your knee(s) and your study surgeon has determined that your knee(s) must be surgically replaced to improve your condition. If you decided to participate in this study, you will be one of approximately one hundred thirty-eight (138) subjects in the study.
This is a prospective, consecutive series, multi-center clinical study of the LEGIONâ„¢ Total Knee System. The study design was selected to assess the safety and effectiveness profile of the LEGIONâ„¢ Total Knee System in subjects with degenerative knee disease requiring primary total knee replacement.
Subjects meeting the entrance criteria specified in this protocol will be approached to participate in the study and enrolled sequentially. Any consenting subjects meeting the inclusion criteria are not to be excluded unless they do not consent to participate. A nonrandomized, consecutive series of up to 138 subjects will be enrolled at a maximum of 8 research sites, with an expectation of 18 subjects (up to a maximum of 28 subjects) to be enrolled at each site. When 138 subjects are enrolled from all sites, enrollment will be stopped, regardless of the number contributed from each site. Sites will be selected for participation in the study at the discretion of Smith & Nephew.
Follow-up clinical assessments will be at Operative/Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years. Each subject will receive a standard radiographic evaluation at discharge that will be used for baseline analysis. Additional radiographic analysis will be performed at Operative/Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEGIONâ„¢ Primary | Other | LEGIONâ„¢ Primary Total Knee Arthroplasty (TKA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Knee Arthroplasty using LEGIONâ„¢ Total Knee System | Procedure | Primary Total Knee Arthroscopy using LEGIONâ„¢ Total Knee System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survivorship Percentage | Kaplan-Meier (KM) implant survivorship where survivorship defined as percentage of knees where no revision was required for any reason through 120 months | Postoperatively through 120 months |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Society Score (KSS) - Performance | The Knee Society Score (KSS) performance outcome comprised information on objective knee indicators related to everyday activities. The Performance Score ranged from 0 to 100 with a higher score indicating a better outcome. | Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months |
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Inclusion Criteria: Subjects must meet all of the inclusion criteria:
Exclusion Criteria: Subjects must not meet any of the exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Associates of Vero Beach | Vero Beach | Florida | 32960 | United States | ||
| Iowa Orthopaedic Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | LEGIONâ„¢ Primary | LEGIONâ„¢ Primary Total Knee Arthroplasty (TKA) Total Knee Arthroplasty using LEGIONâ„¢ Total Knee System: Primary Total Knee Arthroscopy using LEGIONâ„¢ Total Knee System |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The Safety Population (SAF) used as the analysis population. The SAF was defined as all knees (or participants) enrolled into the study that were implanted with the study device. There were 10 participants with bilaterally enrolled knees.
| ID | Title | Description |
|---|---|---|
| BG000 | LEGIONâ„¢ Primary | LEGIONâ„¢ Primary Total Knee Arthroplasty (TKA) Total Knee Arthroplasty using LEGIONâ„¢ Total Knee System: Primary Total Knee Arthroscopy using LEGIONâ„¢ Total Knee System |
| 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 Percentage | Kaplan-Meier (KM) implant survivorship where survivorship defined as percentage of knees where no revision was required for any reason through 120 months | The Safety Population (SAF) used as the analysis population. All knees (or participants) enrolled into the study that were implanted with the study device with available data at the time frame indicated. | Posted | Number | 95% Confidence Interval | percentage of knees | Postoperatively through 120 months | knees | knees |
|
Adverse events were collected from surgery up to 10 years.
Device-related Adverse Event (AE) were any related to device use (e.g., component breakage). All postoperative device & surgery related AEs were reported. Specifically, all component removals (and/or revisions) whether device-related or not were recorded. Other AEs were classified as device-related/non device-related based on their frequency, medical significance, & circumstance. Thus, Investigators reported AE relatedness for device & procedure in the same Case Report Form (CRF) question.
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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 | LEGIONâ„¢ Primary | LEGIONâ„¢ Primary Total Knee Arthroplasty (TKA) Total Knee Arthroplasty using LEGIONâ„¢ Total Knee System: Primary Total Knee Arthroscopy using LEGIONâ„¢ Total Knee System |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemic | Metabolism and nutrition disorders | Systematic Assessment | Unrelated |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Achilles tendonitis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
Limitations of study included high drop-out rate, which was additionally influenced by impact COVID-19 had on subject retention & follow-up rate. Participants lost to follow-up based on presumed loss of power at the 7-year (62.7% follow-up rate) & 10-year (58.5%) time points led to early study termination by Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Howarth | Smith and Nephew | 07540268240 | +44 | michael.howarth@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 | Yes | No | No | Study Protocol | Feb 1, 2011 | Nov 21, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 15, 2021 | Nov 21, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Knee Society Score (KSS) - Function | The Knee Society Score (KSS) function outcome comprised information on functional knee indicators related to walking & standing, standard activities, advanced activities, and discretionary activities. The Function Score ranged from 0 to 100 with a higher score indicating a better outcome. | Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months |
| Knee Osteoarthritis Outcome Score (KOOS) - Pain | The Knee Osteoarthritis Outcome Score (KOOS) Pain subscale used a Likert scale from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with 0 indicated a worse outcome and 100 representing a better outcome. | Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months |
| Knee Osteoarthritis Outcome Score (KOOS) - Symptom | The Knee Osteoarthritis Outcome Score (KOOS) Symptom subscale used a Likert scale from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with 0 indicated a worse outcome and 100 representing a better outcome. | Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months |
| Knee Osteoarthritis Outcome Score (KOOS) - Function in Daily Living (ADL) | The Knee Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) subscale used a Likert scale from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with 0 indicated a worse outcome and 100 representing a better outcome. | Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months |
| Knee Osteoarthritis Outcome Score (KOOS) - Sports and Recreational Activities | The Knee Osteoarthritis Outcome Score (KOOS) Sports and Recreational Activities subscale used a Likert scale from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with 0 indicated a worse outcome and 100 representing a better outcome. | Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months |
| Knee Osteoarthritis Outcome Score (KOOS) - Quality of Life (QoL) | The Knee Osteoarthritis Outcome Score (KOOS) Quality of Life (QoL) subscale used a Likert scale from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with 0 indicated a worse outcome and 100 representing a better outcome. | Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months |
| Radiographic Evaluation - Radiolucent Lines | Performed weight bearing AP and lateral standard x-rays to identify knees with presence or absence of radiolucent lines categorized as:
| Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years |
| Radiographic Evaluation - Observed Periosteal Hypertrophy, Implant Loosening, Osteolysis or Subsidence | Performed weight bearing AP and lateral standard x-rays to identify knees that observed periosteal hypertrophy, implant loosening, osteolysis or subsidence (Yes/No). | Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years |
| Radiographic Evaluation - Observed Patellar Problem | Performed weight bearing AP and lateral standard x-rays to identify knees that observed patellar problems (Yes/No). | Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years |
| Des Moines |
| Iowa |
| 50314 |
| United States |
| Louisville Bone & Joint Specialist, PSC | Louisville | Kentucky | 40207 | United States |
| University Hip and Knee Specialists | Monroe | New Jersey | 08831 | United States |
| University Orthopaedic Associates, LLC | Somerset | New Jersey | 08873 | United States |
| knees |
|
| years |
| Participants |
|
|
| Age, Customized | Measurement evaluated by unit (knees) | Count of Units | knees | knees |
|
|
| Sex: Female, Male | Measurement evaluated by unit (knees) | Count of Units | knees | knees |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | Participants |
|
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 | Participants |
|
|
| Knee side implanted with device | Count of Units | knees | knees |
|
|
| Units | Counts |
|---|
| Participants |
|
| knees |
|
|
| Secondary | Knee Society Score (KSS) - Performance | The Knee Society Score (KSS) performance outcome comprised information on objective knee indicators related to everyday activities. The Performance Score ranged from 0 to 100 with a higher score indicating a better outcome. | The Safety Population (SAF) used as the analysis population. All knees (or participants) enrolled into the study that were implanted with the study device with available data at the time frame indicated. Data for 11 knees at the preoperative time frame were not included because the data was collected prior to signing consent. | Posted | Mean | Standard Deviation | score on a scale | Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months | knees | knees |
|
|
|
| Secondary | Knee Society Score (KSS) - Function | The Knee Society Score (KSS) function outcome comprised information on functional knee indicators related to walking & standing, standard activities, advanced activities, and discretionary activities. The Function Score ranged from 0 to 100 with a higher score indicating a better outcome. | The Safety Population (SAF) used as the analysis population. All knees (or participants) enrolled into the study that were implanted with the study device with available data at the time frame indicated. Data for 11 knees at the preoperative time frame were not included because the data was collected prior to signing consent. | Posted | Mean | Standard Deviation | score on a scale | Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months | knees | knees |
|
|
|
| Secondary | Knee Osteoarthritis Outcome Score (KOOS) - Pain | The Knee Osteoarthritis Outcome Score (KOOS) Pain subscale used a Likert scale from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with 0 indicated a worse outcome and 100 representing a better outcome. | The Safety Population (SAF) used as the analysis population. All knees (or participants) enrolled into the study that were implanted with the study device with available data at the time frame indicated. Data for 11 knees at the preoperative time frame were not included because the data was collected prior to signing consent. | Posted | Mean | Standard Deviation | score on a scale | Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months | knees | knees |
|
|
|
| Secondary | Knee Osteoarthritis Outcome Score (KOOS) - Symptom | The Knee Osteoarthritis Outcome Score (KOOS) Symptom subscale used a Likert scale from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with 0 indicated a worse outcome and 100 representing a better outcome. | The Safety Population (SAF) used as the analysis population. All knees (or participants) enrolled into the study that were implanted with the study device with available data at the time frame indicated. Data for 11 knees at the preoperative time frame were not included because the data was collected prior to signing consent. | Posted | Mean | Standard Deviation | score on a scale | Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months | knees | knees |
|
|
|
| Secondary | Knee Osteoarthritis Outcome Score (KOOS) - Function in Daily Living (ADL) | The Knee Osteoarthritis Outcome Score (KOOS) Function in Daily Living (ADL) subscale used a Likert scale from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with 0 indicated a worse outcome and 100 representing a better outcome. | The Safety Population (SAF) used as the analysis population. All knees (or participants) enrolled into the study that were implanted with the study device with available data at the time frame indicated. Data for 11 knees at the preoperative time frame were not included because the data was collected prior to signing consent. | Posted | Mean | Standard Deviation | score on a scale | Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months | knees | knees |
|
|
|
| Secondary | Knee Osteoarthritis Outcome Score (KOOS) - Sports and Recreational Activities | The Knee Osteoarthritis Outcome Score (KOOS) Sports and Recreational Activities subscale used a Likert scale from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with 0 indicated a worse outcome and 100 representing a better outcome. | The Safety Population (SAF) used as the analysis population. All knees (or participants) enrolled into the study that were implanted with the study device with available data at the time frame indicated. Data for 11 knees at the preoperative time frame were not included because the data was collected prior to signing consent. | Posted | Mean | Standard Deviation | score on a scale | Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months | knees | knees |
|
|
|
| Secondary | Knee Osteoarthritis Outcome Score (KOOS) - Quality of Life (QoL) | The Knee Osteoarthritis Outcome Score (KOOS) Quality of Life (QoL) subscale used a Likert scale from 0 (No Problems) to 4 (Extreme Problems). Scores are transformed to a 0-100 scale, with 0 indicated a worse outcome and 100 representing a better outcome. | The Safety Population (SAF) used as the analysis population. All knees (or participants) enrolled into the study that were implanted with the study device with available data at the time frame indicated. Data for 11 knees at the preoperative time frame were not included because the data was collected prior to signing consent. | Posted | Mean | Standard Deviation | score on a scale | Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months | knees | knees |
|
|
|
| Secondary | Radiographic Evaluation - Radiolucent Lines | Performed weight bearing AP and lateral standard x-rays to identify knees with presence or absence of radiolucent lines categorized as:
| The Safety Population (SAF) used as the analysis population. All knees (or participants) enrolled into the study that were implanted with the study device with available data at the time frame indicated. | Posted | Count of Units | knees | Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years | knees | knees |
|
|
|
| Secondary | Radiographic Evaluation - Observed Periosteal Hypertrophy, Implant Loosening, Osteolysis or Subsidence | Performed weight bearing AP and lateral standard x-rays to identify knees that observed periosteal hypertrophy, implant loosening, osteolysis or subsidence (Yes/No). | The Safety Population (SAF) used as the analysis population. All knees (or participants) enrolled into the study that were implanted with the study device with available data at the time frame indicated. | Posted | Count of Units | knees | Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years | knees | knees |
|
|
|
| Secondary | Radiographic Evaluation - Observed Patellar Problem | Performed weight bearing AP and lateral standard x-rays to identify knees that observed patellar problems (Yes/No). | The Safety Population (SAF) used as the analysis population. All knees (or participants) enrolled into the study that were implanted with the study device with available data at the time frame indicated. | Posted | Count of Units | knees | Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years | knees | knees |
|
|
|
| 4 |
| 128 |
| 75 |
| 128 |
| 116 |
| 128 |
| Ankle fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Back surgery, due to lumbar spondylosis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Buttock abcess | Infections and infestations | Systematic Assessment | Unrelated |
|
| Cardiac stent for heart disease, bigemy | Cardiac disorders | Systematic Assessment | Unrelated |
|
| Chronic rotator cuff tear | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Compression fracture, lower back, due to degeneration lumbar disc | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Compression fracture, lower back | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Compression fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Death - cardiac event | Cardiac disorders | Systematic Assessment | Unrelated |
|
| Death - Parkinson's Disease | Nervous system disorders | Systematic Assessment | Unrelated |
|
| Death - Unknown cause | General disorders | Systematic Assessment | Unrelated |
|
| Deep vein thrombosis, calf | Vascular disorders | Systematic Assessment | Procedure Related |
|
| Deep vein thrombosis, lower extremity | Vascular disorders | Systematic Assessment | Procedure Related |
|
| Deep vein thrombosis, popliteal vein | Vascular disorders | Systematic Assessment | Procedure Related |
|
| Deep vein thrombosis | Vascular disorders | Systematic Assessment | Procedure Related |
|
| Deep vein thrombosis | Vascular disorders | Systematic Assessment | Unrelated |
|
| Diabetes Mellitus | Metabolism and nutrition disorders | Systematic Assessment | Unrelated |
|
| Erosive esophagitis | Gastrointestinal disorders | Systematic Assessment | Unrelated |
|
| Foot navicular stress fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Fracture after component insertion and cementing | Injury, poisoning and procedural complications | Systematic Assessment | Device Related |
|
| Hip fracture with bipolar hemiarthroplasty and knee contusion | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Hip osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Hip pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Hyperparathyroidism | Endocrine disorders | Systematic Assessment | Unrelated |
|
| Hypertension | Cardiac disorders | Systematic Assessment | Unrelated |
|
| Hypotension | Cardiac disorders | Systematic Assessment | Procedure Related |
|
| Hypotension | Cardiac disorders | Systematic Assessment | Unrelated |
|
| Infected total knee | Injury, poisoning and procedural complications | Systematic Assessment | Device Related |
|
| Infection | Infections and infestations | Systematic Assessment | Procedure Related |
|
| Knee arthrofibrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Procedure Related |
|
| Knee effusion | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device Related |
|
| Knee lateral retinacular release | Surgical and medical procedures | Systematic Assessment | Device + Procedure Related |
|
| Knee manipulation under anesthesia, due to arthrofibrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device + Procedure Related |
|
| Knee manipulation under anesthesia, due to stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment | Procedure Related |
|
| Knee manipulation under anesthesia | Surgical and medical procedures | Systematic Assessment | Device Related |
|
| Knee manipulation under anesthesia | Surgical and medical procedures | Systematic Assessment | Procedure Related |
|
| Knee osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Knee patellar tendonitis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Procedure Related |
|
| Knee stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment | Procedure Related |
|
| Lap band procedure | Surgical and medical procedures | Systematic Assessment | Unrelated |
|
| Leg swelling | General disorders | Systematic Assessment | Procedure Related |
|
| Lung cancer, stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Unrelated |
|
| Mechanical loosening of internal knee patella button | Product Issues | Systematic Assessment | Device Related |
|
| Myocardial infarction | Cardiac disorders | Systematic Assessment | Procedure Related |
|
| Olecranon and distal radius fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Patellar clunking | Product Issues | Systematic Assessment | Device Related |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Unrelated |
|
| Radial head fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Respiratory failure, altered mental status and atelactasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Procedure Related |
|
| Shoulder arthoscopy, due to torn rotator cuff | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Spine and ribs fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Splenic artery aneurism embolisation | Vascular disorders | Systematic Assessment | Unrelated |
|
| Superficial wound debricence, post-op | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Total hip arthroplasty, due to hip pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Total hip arthroplasty, due to osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Total hip arthroplasty | Surgical and medical procedures | Systematic Assessment | Unrelated |
|
| Total knee arthroplasty, due to knee pain secondary to degenerative joint disease | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Total knee arthroplasty, due to knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Total knee arthroplasty, due to osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Total knee arthroplasty | Surgical and medical procedures | Systematic Assessment | Unrelated |
|
| Urinary retention | Renal and urinary disorders | Systematic Assessment | Unrelated |
|
| Vertebral compression fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Wrist fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
|
| Anemia | Metabolism and nutrition disorders | Systematic Assessment | Unrelated |
|
| Ankle sprain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Ankle swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device + Procedure Related |
|
| Back and hip pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Back pain and SI joint stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Bakers cyst | Musculoskeletal and connective tissue disorders | Systematic Assessment | Procedure Related |
|
| Bladder control loss and pain | Renal and urinary disorders | Systematic Assessment | Unrelated |
|
| Blisters near incision | Skin and subcutaneous tissue disorders | Systematic Assessment | Procedure Related |
|
| Carpal tunnel, bilateral | Nervous system disorders | Systematic Assessment | Unrelated |
|
| Chronic venous insufficiency lower extremities, bilateral | Vascular disorders | Systematic Assessment | Unrelated |
|
| Clicking knee | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device + Procedure Related |
|
| Clicking knee | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device Related |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment | Unrelated |
|
| Contusion, due to fall | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Cyst anterior knee | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Unrelated |
|
| Degeneration of lumbar intervertebral disc and spinal stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment | Unrelated |
|
| Distal fibular avulsion and left wrist injury, due to fall | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Dizziness | General disorders | Systematic Assessment | Unrelated |
|
| Dupuytren's middle finger | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Erythema of incision | Skin and subcutaneous tissue disorders | Systematic Assessment | Procedure Related |
|
| Exostosis lateral femoral condyle knee | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Fall | General disorders | Systematic Assessment | Unrelated |
|
| Fever | General disorders | Systematic Assessment | Unrelated |
|
| Finger contusions | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Foot and ankle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Foot and ankle partial tear | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Foot neuropathy | Nervous system disorders | Systematic Assessment | Unrelated |
|
| Foot pain, bilateral | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Foot pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Groin pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Hand pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Headache | General disorders | Systematic Assessment | Unrelated |
|
| Heretopic ossification | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device Related |
|
| Herniated disc | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Heterotopic ossification infra patella | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Heterotopic ossification of femoral component | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device + Procedure Related |
|
| Heterotopic ossification | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device Related |
|
| Hip and knee pain, due to IT band friction syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Hip pain and sciatica | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Hip pain, bilateral | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Hip pain, due to osteoarthritis and trochanteric bursitis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Hip pain, due to osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Hip pain, lateral | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Hip pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Hypertrophic scar formation | Skin and subcutaneous tissue disorders | Systematic Assessment | Procedure Related |
|
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment | Unrelated |
|
| Index finder | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Index finger | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| IT band irritation | Musculoskeletal and connective tissue disorders | Systematic Assessment | Procedure Related |
|
| Knee arthrofibrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Knee bakers cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Procedure Related |
|
| Knee buckling | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Knee clicking and grinding | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device + Procedure Related |
|
| Knee clicking | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device + Procedure Related |
|
| Knee clicking | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device Related |
|
| Knee contusion, bilateral | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Knee contusion, due to fall | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Knee contusion | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Knee crackling when standing | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Knee hematoma and contusion, due to fall | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Knee hematoma | Skin and subcutaneous tissue disorders | Systematic Assessment | Procedure Related |
|
| Knee hyperextension | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device + Procedure Related |
|
| Knee instability | Musculoskeletal and connective tissue disorders | Systematic Assessment | Procedure Related |
|
| Knee instability | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Knee lateral swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Knee lump and pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Knee osteoarthritis with crepitus | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Knee osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Knee pain and bruising, due to fall | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Knee pain with swelling and redness around patella | Skin and subcutaneous tissue disorders | Systematic Assessment | Procedure Related |
|
| Knee pain, bilateral | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Knee pain, due to contusion | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Knee pain, due to fall | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device + Procedure Related |
|
| Knee pain, due to fall | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Knee pain, due to MVA | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device Related |
|
| Knee pain, due to osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device + Procedure Related |
|
| Knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device Related |
|
| Knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Procedure Related |
|
| Knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Knee pes anserine bursitis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Knee popping | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device + Procedure Related |
|
| Knee popping | Musculoskeletal and connective tissue disorders | Systematic Assessment | Procedure Related |
|
| Knee posteriolateral popping, occasional | Musculoskeletal and connective tissue disorders | Systematic Assessment | Procedure Related |
|
| Knee soft tissue pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Knee stiffness post manipulation | Musculoskeletal and connective tissue disorders | Systematic Assessment | Procedure Related |
|
| Knee stiffness, post op | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Knee stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Knee strain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Knee swelling, due to infection | Infections and infestations | Systematic Assessment | Procedure Related |
|
| Knee swelling, intermittent | Musculoskeletal and connective tissue disorders | Systematic Assessment | Procedure Related |
|
| Knee swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment | Procedure Related |
|
| Knee swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Knee tenderness along MCL | Musculoskeletal and connective tissue disorders | Systematic Assessment | Procedure Related |
|
| Knee tenderness along MCL | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Knee tenderness and bruising, due to fall | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Knee tightness | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device + Procedure Related |
|
| Knee wound infection drainage | Infections and infestations | Systematic Assessment | Procedure Related |
|
| Lateral knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Lateral patella tilt and impingment | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device Related |
|
| Lateral subluxation and patella tilt | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device Related |
|
| Leg pain, due to advanced arthritic changes of lumbar spine | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Leg swelling and ecchymosis | Skin and subcutaneous tissue disorders | Systematic Assessment | Procedure Related |
|
| Lower back and groin pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Lower back and hip pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Lower back pain and sciatica | Nervous system disorders | Systematic Assessment | Unrelated |
|
| Lower back pain radiating to lower extremities | Nervous system disorders | Systematic Assessment | Unrelated |
|
| Lower back pain with radiculopathy | Nervous system disorders | Systematic Assessment | Unrelated |
|
| Lower back pain, due to degeneration of lumbar intervertebral disc, spondylosis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Lower back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Lower calf clot | Vascular disorders | Systematic Assessment | Unrelated |
|
| Lower extremity swelling | Skin and subcutaneous tissue disorders | Systematic Assessment | Unrelated |
|
| Lumbar pain, due to sciatica-lumbar radiculopathy | Nervous system disorders | Systematic Assessment | Unrelated |
|
| Lumbar radiculitis and spasm | Nervous system disorders | Systematic Assessment | Unrelated |
|
| Lumbar radiculopathy and sciatica | Nervous system disorders | Systematic Assessment | Unrelated |
|
| Lumbar spondylosis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| MVA | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Patella heterotopic ossification | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device Related |
|
| Patella periosteal hypertrophy | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device Related |
|
| Patellar Subluxation | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device + Procedure Related |
|
| Peroneal nerve palsy | Nervous system disorders | Systematic Assessment | Procedure Related |
|
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Reabsorption on the medial tibial plateau | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device Related |
|
| Sacroilliac pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Sciatica and spasm | Nervous system disorders | Systematic Assessment | Unrelated |
|
| Sciatica | Nervous system disorders | Systematic Assessment | Unrelated |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Unrelated |
|
| Shoulder bursitis and osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Shoulder fracture, due to fall | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Shoulder pain, bilateral | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Shoulder pain, due to impingement | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Shoulder pain, due to severe glenohumeral DJD | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Shoulder rotator cuff tear | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Shoulder stiffness, due to post op | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Shuffling gait | General disorders | Systematic Assessment | Unrelated |
|
| Spinal stenosis and sciatica | General disorders | Systematic Assessment | Unrelated |
|
| Spinal stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Spondylosis and allied disorder | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Spondylosis and sacroilliac joint inflamed | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Stenosing tenosynovitis finger | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Thumb pain, due to arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Tingling anterior thigh | Nervous system disorders | Systematic Assessment | Unrelated |
|
| Total hip, post-op | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Total shoulder, pre op | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Trochanteric bursitis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
|
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment | Unrelated |
|
| Vertigo | Nervous system disorders | Systematic Assessment | Unrelated |
|
| Weakness, due to low sodium | Metabolism and nutrition disorders | Systematic Assessment | Unrelated |
|
| Weight gain | General disorders | Systematic Assessment | Unrelated |
|
Not provided
| D012216 |
| Rheumatic Diseases |
| 3 months |
|
|
| 12 months |
|
|
| 24 months |
|
|
| 36 months |
|
|
| 60 months |
|
|
| 84 months |
|
|
| 120 months |
|
|
| 3 months |
|
|
| 12 months |
|
|
| 24 months |
|
|
| 36 months |
|
|
| 60 months |
|
|
| 84 months |
|
|
| 120 months |
|
|
| 3 months |
|
|
| 12 months |
|
|
| 24 months |
|
|
| 36 months |
|
|
| 60 months |
|
|
| 84 months |
|
|
| 120 months |
|
|
| 3 months |
|
|
| 12 months |
|
|
| 24 months |
|
|
| 36 months |
|
|
| 60 months |
|
|
| 84 months |
|
|
| 120 months |
|
|
| 3 months |
|
|
| 12 months |
|
|
| 24 months |
|
|
| 36 months |
|
|
| 60 months |
|
|
| 84 months |
|
|
| 120 months |
|
|
| 3 months |
|
|
| 12 months |
|
|
| 24 months |
|
|
| 36 months |
|
|
| 60 months |
|
|
| 84 months |
|
|
| 120 months |
|
|
| 3 months |
|
|
| 12 months |
|
|
| 24 months |
|
|
| 36 months |
|
|
| 60 months |
|
|
| 84 months |
|
|
| 120 months |
|
|
| Findings in Tibial ML Zone |
|
| Findings in Tibial AP Zone |
|
| Findings in Patella Zone |
|
| No Radiolucent Lines Found |
|
| 3 months |
|
|
| 1 year |
|
|
| 2 years |
|
|
| 3 years |
|
|
| 5 years |
|
|
| 7 years |
|
|
| 10 years |
|
|
| No |
|
| 3 months |
|
|
| 1 year |
|
|
| 2 years |
|
|
| 3 years |
|
|
| 5 years |
|
|
| 7 years |
|
|
| 10 years |
|
|
| No |
|
| 3 months |
|
|
| 1 year |
|
|
| 2 years |
|
|
| 3 years |
|
|
| 5 years |
|
|
| 7 years |
|
|
| 10 years |
|
|