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Poor enrollment
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The purpose of this study is to demonstrate that the Uniglide™ Mobile Bearing Unicondylar Knee System (investigational device)is not inferior when compared to the Uniglide™ Fixed Bearing Unicondylar Knee System (control device currently cleared) as measured by the Composite Clinical Success (CCS) endpoint.
Arthritic knees are the most common cause of long-term disability resulting in decreased mobility and increased pain. After other treatments for pain relief and return to activities of daily living fail, knee joint replacement is often the best option and unicompartmental knee arthroplasty was introduced as an appropriate treatment for management of osteoarthritis when disease effects only a portion of the knee joint. This study is a prospective, comparative, randomized, double blind (patient and post-operative evaluator), multi-center clinical study under a common protocol to determine the safety and effectiveness of the Uniglide Unicondylar Mobile Bearing knee implant system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uniglide Mobile Bearing | Experimental | Uniglide Mobile Bearing Unicondylar Knee System (MBK) |
|
| Uniglide Fixed Bearing | Active Comparator | Uniglide Fixed Bearing Unicondylar Knee System (FBK) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Uniglide Mobile Bearing Unicondylar Knee System | Device | Uniglide Mobile Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo)that articulates with a mobile bearing tibial construct comprised of a cobalt chromium molybdenum (CoCrMo)tibial base plate and ultra high molecular weight polyethylene (UHMWPE) meniscal insert. The femoral component has been cleared as part of the fixed bearing version in K050764. The investigational portion of this device is the mobile bearing tibial construct (tibial tray and meniscal insert). |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Implants Which Achieve Composite Clinical Success (CCS) at Month 24. | CCS success criteria includes the following: Hospital for Special Surgery (HSS) success: ≥ 70 and; If preop HSS between 60-69, HSS ≥ 70 plus a min 10 point improvement; No radiographic failure: No radiolucent lines >1mm in >50% of zones around any component; No progressive radiolucencies; No radiographic evidence of implant subsidence (vertical displacement) > 2mm of any component; No radiographic evidence of aseptic implant loosening, i.e. no changes in angular orientations > 2 degrees; No removal, replacement, or revision (including planned removal, replacement, or revision) of any component (including the bearing) on or before day 730 following initial surgery. | Month 24 postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| American Knee Society Score (AKSS) (Total, Pain & Function Scores) | American Knee Society Score (AKSS) Total Score - Range: 0 (worst) - 100 (best) Pain Score - Range: 0 (worst) - 50 (best) Function Score - Range: 0 (worst) - 100 (best) | Month 24 postoperative |
| Hospital for Special Surgery (HSS) Score (Total, Pain & Function Scores) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janice Fleming | Corin Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S.T.A.R. Orthopaedics, Inc. | La Quinta | California | 92253 | United States | ||
| Orthopaedic Associates of West Florida |
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| ID | Title | Description |
|---|---|---|
| FG000 | Uniglide Mobile Bearing Unicondylar Knee System (MBK) | Uniglide Mobile Bearing Unicondylar Knee System (MBK) Uniglide Mobile Bearing Unicondylar Knee System: Uniglide Mobile Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a mobile bearing tibial construct comprised of a cobalt chromium molybdenum (CoCrMo) tibial base plate and ultra high molecular weight polyethylene (UHMWPE) meniscal insert. The femoral component has been cleared as part of the fixed bearing version in K050764. The investigational portion of this device is the mobile bearing tibial construct (tibial tray and meniscal insert). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Uniglide Fixed Bearing Unicondylar Knee System | Device | Uniglide Fixed Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a one piece ultra high molecular weight polyethylene (UHMWPE) tibial bearing (K050764). |
|
|
HSS (total): range 0 (worst) - 100 (best) HSS (pain): range 0 (worst) - 30 (best) HSS (function): range 0 (worst) - 22 (best) |
| Month 24 postoperative |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) (Pain, Symptoms, Activities of Daily Living, Sports/Rec & Quality of Life Scores) | Knee injury and Osteoarthritis Outcome Score (pain): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (symptoms): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (activities of daily living (ADL)): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (sport/rec): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (quality of life (QOL)): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (sport and recreation): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (quality of life): 0 (worst) - 100 (best) | Month 24 postoperative |
| Survival Rate Using Kaplan-Meier Survival Curves | Kaplan-Meier survival curves will be plotted for All Enrolled investigational devices and All Enrolled control devices on the same graph to facilitate graphical comparisons of survivorship over time. | Month 24 postoperative |
| Number of Implants With Any Device-related Complications | Month 24 postoperative |
| The Number of Implants With Any Radiographic Findings at Month 24 Post Operatively | For both the Tibial & Femoral Components the following were recorded: Implant Subsidence > 2mm (recorded for the tibial component only) Implant Loosening > 2deg Radiolucent Line (RLL) in >50% zones Progressive RLL Osteolysis ≥ 5mm | Month 24 postoperative |
| Clearwater |
| Florida |
| 33756 |
| United States |
| Bluegrass Orthopaedics and Hand Care | Lexington | Kentucky | 40509 | United States |
| Texas Orthopedic Specialists | Bedford | Texas | 76021 | United States |
| Memorial Bone & Joint | Houston | Texas | 77043 | United States |
| Texas Center for Joint Replacement | Plano | Texas | 75093 | United States |
| FG001 | Uniglide Fixed Bearing Unicondylar Knee System (FBK) | Uniglide Fixed Bearing Unicondylar Knee System (FBK) Uniglide Fixed Bearing Unicondylar Knee System: Uniglide Fixed Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a one piece ultra high molecular weight polyethylene (UHMWPE) tibial bearing (K050764). |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Uniglide Mobile Bearing Unicondylar Knee System (MBK) | Uniglide Mobile Bearing Unicondylar Knee System (MBK) Uniglide Mobile Bearing Unicondylar Knee System: Uniglide Mobile Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a mobile bearing tibial construct comprised of a cobalt chromium molybdenum (CoCrMo) tibial base plate and ultra high molecular weight polyethylene (UHMWPE) meniscal insert. The femoral component has been cleared as part of the fixed bearing version in K050764. The investigational portion of this device is the mobile bearing tibial construct (tibial tray and meniscal insert). |
| BG001 | Uniglide Fixed Bearing Unicondylar Knee System (FBK) | Uniglide Fixed Bearing Unicondylar Knee System (FBK) Uniglide Fixed Bearing Unicondylar Knee System: Uniglide Fixed Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a one piece ultra high molecular weight polyethylene (UHMWPE) tibial bearing (K050764). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Implants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years | Implants |
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| Sex: Female, Male | Count of Units | Implants | Implants |
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| Region of Enrollment | Number | Implants | Implants |
|
| 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 | The Number of Implants Which Achieve Composite Clinical Success (CCS) at Month 24. | CCS success criteria includes the following: Hospital for Special Surgery (HSS) success: ≥ 70 and; If preop HSS between 60-69, HSS ≥ 70 plus a min 10 point improvement; No radiographic failure: No radiolucent lines >1mm in >50% of zones around any component; No progressive radiolucencies; No radiographic evidence of implant subsidence (vertical displacement) > 2mm of any component; No radiographic evidence of aseptic implant loosening, i.e. no changes in angular orientations > 2 degrees; No removal, replacement, or revision (including planned removal, replacement, or revision) of any component (including the bearing) on or before day 730 following initial surgery. | Posted | Count of Units | Implants | Month 24 postoperative | Implants | Implants |
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| ||||||||||||||||||||||||||||||
| Secondary | American Knee Society Score (AKSS) (Total, Pain & Function Scores) | American Knee Society Score (AKSS) Total Score - Range: 0 (worst) - 100 (best) Pain Score - Range: 0 (worst) - 50 (best) Function Score - Range: 0 (worst) - 100 (best) | Posted | Mean | Standard Deviation | score on a scale | Month 24 postoperative | Implants | Implants |
| |||||||||||||||||||||||||||||||
| Secondary | Hospital for Special Surgery (HSS) Score (Total, Pain & Function Scores) | HSS (total): range 0 (worst) - 100 (best) HSS (pain): range 0 (worst) - 30 (best) HSS (function): range 0 (worst) - 22 (best) | Posted | Mean | Standard Deviation | score on a scale | Month 24 postoperative | Implants | Implants |
| |||||||||||||||||||||||||||||||
| Secondary | Knee Injury and Osteoarthritis Outcome Score (KOOS) (Pain, Symptoms, Activities of Daily Living, Sports/Rec & Quality of Life Scores) | Knee injury and Osteoarthritis Outcome Score (pain): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (symptoms): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (activities of daily living (ADL)): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (sport/rec): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (quality of life (QOL)): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (sport and recreation): 0 (worst) - 100 (best) Knee injury and Osteoarthritis Outcome Score (quality of life): 0 (worst) - 100 (best) | Posted | Mean | Standard Deviation | score on a scale | Month 24 postoperative | Implants | Implants |
| |||||||||||||||||||||||||||||||
| Secondary | Survival Rate Using Kaplan-Meier Survival Curves | Kaplan-Meier survival curves will be plotted for All Enrolled investigational devices and All Enrolled control devices on the same graph to facilitate graphical comparisons of survivorship over time. | Posted | Count of Units | Implants | Month 24 postoperative | Implants | Implants |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Implants With Any Device-related Complications | Posted | Count of Units | Implants | Month 24 postoperative | Implants | Implants |
|
| ||||||||||||||||||||||||||||||||
| Secondary | The Number of Implants With Any Radiographic Findings at Month 24 Post Operatively | For both the Tibial & Femoral Components the following were recorded: Implant Subsidence > 2mm (recorded for the tibial component only) Implant Loosening > 2deg Radiolucent Line (RLL) in >50% zones Progressive RLL Osteolysis ≥ 5mm | Posted | Count of Units | Implants | Month 24 postoperative | Implants | Implants |
|
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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 | Uniglide Mobile Bearing Unicondylar Knee System (MBK) | Uniglide Mobile Bearing Unicondylar Knee System (MBK) Uniglide Mobile Bearing Unicondylar Knee System: Uniglide Mobile Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a mobile bearing tibial construct comprised of a cobalt chromium molybdenum (CoCrMo) tibial base plate and ultra high molecular weight polyethylene (UHMWPE) meniscal insert. The femoral component has been cleared as part of the fixed bearing version in K050764. The investigational portion of this device is the mobile bearing tibial construct (tibial tray and meniscal insert). | 0 | 22 | 6 | 22 | 20 | 22 |
| EG001 | Uniglide Fixed Bearing Unicondylar Knee System (FBK) | Uniglide Fixed Bearing Unicondylar Knee System (FBK) Uniglide Fixed Bearing Unicondylar Knee System: Uniglide Fixed Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a one piece ultra high molecular weight polyethylene (UHMWPE) tibial bearing (K050764). | 0 | 15 | 7 | 15 | 14 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic lymphocytic leukaemia anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Chronic lymphocytic leukaemia progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Contralateral hip arthrotomy for loose body removal | Surgical and medical procedures | Systematic Assessment |
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| Contralateral UKR | Surgical and medical procedures | Systematic Assessment |
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| Contralateral TKR | Surgical and medical procedures | Systematic Assessment |
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| Closed reduction percutaneous screw fixation of ipsilateral subcapital femoral neck fracture | Surgical and medical procedures | Systematic Assessment |
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| Revision for meniscal bearing dislocation | Surgical and medical procedures | Systematic Assessment |
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| Revision for periprosthetic fracture | Surgical and medical procedures | Systematic Assessment |
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| Carpal tunnel release surgery | Surgical and medical procedures | Systematic Assessment |
| ||
| Contralateral knee hematoma drainage | Surgical and medical procedures | Systematic Assessment |
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| Contralateral knee traumatic wound dehiscence | Surgical and medical procedures | Systematic Assessment |
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| Gastrointestinal polyp removal | Surgical and medical procedures | Systematic Assessment |
| ||
| Knee hematoma drainage (operative side) | Surgical and medical procedures | Systematic Assessment |
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| Lumbago | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Traumatic knee-wound dehiscence (operative side) | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Achiness and sensitivity both knees | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Acute post-op blood loss anemia | Injury, poisoning and procedural complications | Systematic Assessment |
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| Ankle swelling | Injury, poisoning and procedural complications | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Contralateral hallux rigidus surgery | Surgical and medical procedures | Systematic Assessment |
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| Contralateral hip OA | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Contralateral hip pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Contralateral knee crepitus | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Contralateral knee OA | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Contralateral knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Contralateral meniscus tear | Injury, poisoning and procedural complications | Systematic Assessment |
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| Contralateral twisted knee | Injury, poisoning and procedural complications | Systematic Assessment |
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| Drainage from incision | Surgical and medical procedures | Systematic Assessment |
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| Fever | Infections and infestations | Systematic Assessment |
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| Gas pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Heartburn | Gastrointestinal disorders | Systematic Assessment |
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| Heterotopic ossification (operative side) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Indigestion | Gastrointestinal disorders | Systematic Assessment |
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| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Knee and ankle swelling (operative side) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Knee crepitus (operative side) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Knee pain (operative side) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Knee swelling and discomfort (operative side) | Injury, poisoning and procedural complications | Systematic Assessment |
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| Left elbow and head bruising | Injury, poisoning and procedural complications | Systematic Assessment |
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| Muscle spasm | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Nausea and vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Numbness and tingling | Nervous system disorders | Systematic Assessment |
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| Off-label drill bit breakage during surgery | Injury, poisoning and procedural complications | Systematic Assessment |
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| Pes anserine bursitis (operative side) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Post-fall bruised knee (operative side) | Injury, poisoning and procedural complications | Systematic Assessment |
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| Post-fall contralateral knee pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Post-fall knee contusion (operative side) | Injury, poisoning and procedural complications | Systematic Assessment |
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| Post-fall knee pain (operative side) | Injury, poisoning and procedural complications | Systematic Assessment |
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| Productive cough with yellow discharge | Infections and infestations | Systematic Assessment |
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| Rash on back and chest | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin cancer (left shin) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Sleeplessness | General disorders | Systematic Assessment |
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| Sore throat | Infections and infestations | Systematic Assessment |
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| Total hysterectomy | Reproductive system and breast disorders | Systematic Assessment |
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| Twisted knee (operative side) | Injury, poisoning and procedural complications | Systematic Assessment |
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| Uncharacteristic pain (operative side) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| All over general itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| C-6 calcification | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Contralateral knee arthroscopy | Surgical and medical procedures | Systematic Assessment |
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| Contralateral pes anserine bursitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Early degenerative changes in lumbar spine | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Elbow pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Elevated blood pressure | Cardiac disorders | Systematic Assessment |
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| Fractured foot | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hypertension | Cardiac disorders | Systematic Assessment |
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| Insomnia | General disorders | Systematic Assessment |
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| Ipsilateral hip bursitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Knee arthroscopy (operative side) | Surgical and medical procedures | Systematic Assessment |
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| Knee locking (operative side) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Lethargy | General disorders | Systematic Assessment |
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| Mole removal | Surgical and medical procedures | Systematic Assessment |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nausea and vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Nervousness | Psychiatric disorders | Systematic Assessment |
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| Occasional contralateral intertrochanteric hip pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Post-fall bruised contralateral knee | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Post-op nausea | Injury, poisoning and procedural complications | Systematic Assessment |
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| Progression of OA | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Vomiting and diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Regulatory Affairs and Clinical Director | Corin | +44 (0)1285 659866 |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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| Units | Counts |
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| Units | Counts |
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Uniglide Fixed Bearing Unicondylar Knee System (FBK) Uniglide Fixed Bearing Unicondylar Knee System: Uniglide Fixed Bearing Knee System includes a femoral component made of cobalt chromium molybdenum (CoCrMo) that articulates with a one piece ultra high molecular weight polyethylene (UHMWPE) tibial bearing (K050764). |
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