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| Name | Class |
|---|---|
| University of Oxford | OTHER |
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X-rays are the most frequently used imaging test when evaluating the knee for joint replacement. They are non-invasive, safe and cost effective. They allow assessment of: progression of disease, appropriateness for joint replacement (in particular unicompartmental knee replacement (UKR)) as well as likely prognosis following replacement.
Currently standard assessment involves: standing anteroposterior, lateral and skyline X-ray views. In addition in patients being considered for joint replacement valgus/varus stress X-rays are used to evaluate the lateral compartment (as well as medial collateral ligament) and medial compartment respectively to assess the status of the cartilage. Stress X-rays require the clinician to attend X-ray, often during busy clinics, exposing them to additional radiation, and as such they are seldom performed.
A patient and user friendly device for performing valgus and varus stress X-rays of the knee for diagnostic and pre-operative planning purposes in the setting of knee replacement surgery has been developed. This device has the potential to benefit patients as it will allow an accurate assessment of the pattern and severity of arthritis affecting their knee without the need for additional diagnostics such as MRI or arthroscopy. Furthermore for healthcare practitioners and providers this device will facilitate the smooth running of clinics and reduce the additional clinic appointments required to review MRI results. Ultimately this device will allow an informed discussion about treatment options, reduce the pre-operative uncertainty about suitability for UKR in those undergoing surgery and ensure that those patients who are suitable for UKR benefit from this procedure. This device will help ensure that patients receive the optimum treatment in a clinically and cost efficient manner.
This study will validate valgus and varus stress X-rays performed using the investigators' device against the gold standard of clinician performed manual stress.
X-rays are the most frequently used imaging test when evaluating the knee for joint replacement. They are non-invasive, safe and cost effective. They allow assessment of: progression of disease, appropriateness for joint replacement (in particular unicompartmental knee replacement (UKR)) as well as likely prognosis following replacement.
Currently standard assessment involves: standing anteroposterior, lateral and skyline X-ray views. In addition in patients being considered for joint replacement valgus/varus stress X-rays are used to evaluate the lateral compartment (as well as medial collateral ligament) and medial compartment respectively to assess the status of the cartilage.
The assessment of pattern and severity of disease is critical when evaluating suitability for joint replacement and well as when deciding between total knee replacement (TKR), where all articulating surface are replaced, or UKR, where only the diseased portion of the joint is replaced. Understanding the pattern of disease is essential to ensure appropriate patient selection for UKR, which is appropriate in up to half of patients undergoing knee replacement, and has significant benefits over TKR including: half the risk of venous thromboembolism, myocardial infarction or deep infection, two thirds the risk of stroke, one quarter the risk of blood transfusion and significantly lower mortality up to eight years following their operation.
Stress X-rays are currently performed by the clinician, requiring them to attend radiology, often during clinic. To perform the stress views the clinician fixes the knee and moves the tibia away from the midline, valgus stress, where an X-ray is taken. The alignment of this view is confirmed before the tibia is moved towards the midline, varus stress, where another X-ray is taken. Stress X-rays are resource dependent and can be time consuming. In addition, the technique can be uncomfortable for patients as well as resulting in additional radiation exposure to the clinical practitioner. On an average, a knee surgeon may be exposing themselves to excess of 300 exposures every year with the cumulative effect of radiation exposure being significant. As such in many centers stress views are often not performed, and as standing antero-posterior X-ray views are inadequate to assess disease severity and pattern many clinicians have adopted additional imaging modalities such as MRI or direct observation via arthroscopy to evaluate the status of the cartilage in each compartment. The use of these additional imaging techniques introduces significant additional costs as well as delays to treatment. Furthermore the long term outcomes of UKR have been established using stress views, and as a consequence outcomes based on MRI or arthroscopic findings have not been fully established.
A patient and user friendly device for performing valgus and varus stress X-rays of the knee for diagnostic and pre-operative planning purposes in the setting of knee replacement surgery has been developed. This device has the potential to benefit patients as it will allow an accurate assessment of the pattern and severity of arthritis affecting their knee without the need for additional diagnostics such as MRI or arthroscopy. Furthermore for healthcare practitioners and providers this device will facilitate the smooth running of clinics and reduce the additional clinic appointments required to review MRI results. Ultimately this device will allow an informed discussion about treatment options, reduce the pre-operative uncertainty about suitability for UKR in those undergoing surgery and ensure that those patients who are suitable for UKR benefit from this procedure. This device will help ensure that patients receive the optimum treatment in a clinically and cost efficient manner.
This study will validate valgus and varus stress X-rays performed using the investigators' device against the gold standard of clinician performed manual stress.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinician Valgus | Active Comparator | Clinician performed fluoroscopic valgus and varus stress X-rays |
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| Clinician Varus | Active Comparator | Clinician performed fluoroscopic varus stress X-rays |
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| Device Valgus - 0 Newton force | Experimental | Device performed fluoroscopic valgus stress X-rays - 0 Newton force |
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| Device Valgus - 10 Newton force | Experimental | Device performed fluoroscopic valgus stress X-rays - 10 Newton force |
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| Device Valgus - 20 Newton force | Experimental | Device performed fluoroscopic valgus stress X-rays - 20 Newton force |
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| Device Valgus - 30 Newton force | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinician Valgus | Radiation | Clinician performed valgus stress X-ray under fluoroscopy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Compartment Specific Knee Minimum Joint Space Width (Varus - Medial Compartment, Valgus - Lateral Compartment) | Knee minimum joint space width measured on anteroposterior fluoroscopic images using custom, validated, in house software (KneeMorph, MATLAB, MathWorks, Massachusetts). | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain (VAS 0 - 10) | Pain Score during stress radiographs (VAS 0 - 10) where a higher score represents more pain (10 = worst pain). | At time of procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Label | URL |
|---|---|
| Oxford Orthopaedic Engineering Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford | View source |
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In total 9 participants recruited with the interventions in each arm applied to all participants
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | All study participants Clinician Valgus Clinician Varus Device Valgus 0N Device Valgus 10N Device Valgus 20N Device Valgus 30N Device Varus 0N Device Varus 10N Device Varus 20N Device Varus 30N |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Clinician Valgus |
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Participants will have the interventions in each of the ten arms of the study.
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Device performed fluoroscopic valgus stress X-rays - 30 Newton force
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| Device Varus - 0 Newton force | Experimental | Device performed fluoroscopic varus stress X-rays - 0 Newton force |
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| Device Varus - 10 Newton force | Experimental | Device performed fluoroscopic varus stress X-rays - 10 Newton force |
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| Device Varus - 20 Newton force | Experimental | Device performed fluoroscopic varus stress X-rays - 20 Newton force |
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| Device Varus - 30 Newton force | Experimental | Device performed fluoroscopic varus stress X-rays - 30 Newton force |
|
| Clinician Varus |
| Radiation |
Clinician performed varus stress X-ray under fluoroscopy |
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| Device Valgus - 0 Newton | Radiation | Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy. |
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| Device Valgus - 10 Newton | Radiation | Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed varus stress X-ray under fluoroscopy. |
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| Device Valgus - 20 Newton | Radiation | Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy. |
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| Device Valgus - 30 Newton | Radiation | Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy. |
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| Device Varus - 0 Newton | Radiation | Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy. |
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| Device Varus - 10 Newton | Radiation | Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy. |
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| Device Varus - 20 Newton | Radiation | Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy. |
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| Device Varus - 30 Newton | Radiation | Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy. |
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| COMPLETED |
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| NOT COMPLETED |
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| Clinician Varus |
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| Device Valgus 0N |
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| Device Valgus 10N |
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| Device Valgus 20N |
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| Device Valgus 30N |
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| Device Varus 0N |
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| Device Varus 10N |
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| Device Varus 20N |
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| Device Varus 30N |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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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 | Compartment Specific Knee Minimum Joint Space Width (Varus - Medial Compartment, Valgus - Lateral Compartment) | Knee minimum joint space width measured on anteroposterior fluoroscopic images using custom, validated, in house software (KneeMorph, MATLAB, MathWorks, Massachusetts). | Posted | Mean | Standard Deviation | mm | Day 0 |
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| Secondary | Pain (VAS 0 - 10) | Pain Score during stress radiographs (VAS 0 - 10) where a higher score represents more pain (10 = worst pain). | Posted | Mean | Standard Deviation | units on a scale | At time of procedure |
|
6 months
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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 | Clinician Valgus | Clinician performed fluoroscopic valgus and varus stress X-rays Clinician Valgus: Clinician performed valgus stress X-ray under fluoroscopy | 0 | 9 | 0 | 9 | 0 | 9 |
| EG001 | Clinician Varus | Clinician performed fluoroscopic varus stress X-rays Clinician Varus: Clinician performed varus stress X-ray under fluoroscopy | 0 | 9 | 0 | 9 | 0 | 9 |
| EG002 | Device Valgus - 0 Newton Force | Device performed fluoroscopic valgus stress X-rays - 0 Newton force Device Valgus - 0 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG003 | Device Valgus - 10 Newton Force | Device performed fluoroscopic valgus stress X-rays - 10 Newton force Device Valgus - 10 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed varus stress X-ray under fluoroscopy. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG004 | Device Valgus - 20 Newton Force | Device performed fluoroscopic valgus stress X-rays - 20 Newton force Device Valgus - 20 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG005 | Device Valgus - 30 Newton Force | Device performed fluoroscopic valgus stress X-rays - 30 Newton force Device Valgus - 30 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG006 | Device Varus - 0 Newton Force | Device performed fluoroscopic varus stress X-rays - 0 Newton force Device Varus - 0 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG007 | Device Varus - 10 Newton Force | Device performed fluoroscopic varus stress X-rays - 10 Newton force Device Varus - 10 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG008 | Device Varus - 20 Newton Force | Device performed fluoroscopic varus stress X-rays - 20 Newton force Device Varus - 20 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG009 | Device Varus - 30 Newton Force | Device performed fluoroscopic varus stress X-rays - 30 Newton force Device Varus - 30 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy. | 0 | 9 | 0 | 9 | 0 | 9 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Hamilton, Clinical Research Fellow | University of Oxford | 01865227696 | thomas.hamilton@ndorms.ox.ac.uk |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| OG004 | Device Valgus - 20 Newton Force | Device performed fluoroscopic valgus stress X-rays - 20 Newton force Device Valgus - 20 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy. |
| OG005 | Device Valgus - 30 Newton Force | Device performed fluoroscopic valgus stress X-rays - 30 Newton force Device Valgus - 30 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy. |
| OG006 | Device Varus - 0 Newton Force | Device performed fluoroscopic varus stress X-rays - 0 Newton force Device Varus - 0 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy. |
| OG007 | Device Varus - 10 Newton Force | Device performed fluoroscopic varus stress X-rays - 10 Newton force Device Varus - 10 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy. |
| OG008 | Device Varus - 20 Newton Force | Device performed fluoroscopic varus stress X-rays - 20 Newton force Device Varus - 20 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy. |
| OG009 | Device Varus - 30 Newton Force | Device performed fluoroscopic varus stress X-rays - 30 Newton force Device Varus - 30 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy. |
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