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Unicompartmental knee replacement for selected cases of osteoarthritis is less invasive than total knee replacement. It gives better range of movement; patients stay for shorter time in the hospital and have a more natural feel than total knee replacement. Usually, the implant is fixed in the bone using bone cement. However, there are potential disadvantages of using bone cement. The operation takes longer; cement can get squeezed out into the surrounding tissues and may interfere with function. To avoid these problems, the implant can be fixed without cement. Cementless components have a special coating to encourage bone in-growth and fixation. Although the investigators believe cementless fixation will be at least as good as cemented fixation, there is a risk that it could be worse and might result in loosening.
The aim of this study is therefore to compare the outcome of cemented and cementless unicompartmental knee replacement.
Design: A prospective, randomised trial to compare the outcome of cemented and cementless unicompartmental knee replacement.
Size: 40 subjects in total will be recruited with 20 in each arm.
Methods: Patients will be recruited from the routine waiting list for unicompartmental knee replacement at the Nuffield Orthopaedic Centre. All subjects will have the procedure explained and be fully consented prior to the procedure.
Randomisation: Patients will be randomly allocated to receive either a cemented or cementless Oxford Unicompartmental Knee Replacement. This will be performed using a randomisation program based on optimisation (Minim). Subjects will be stratified according to sex and age.
Operation: All subjects will undergo the same surgical approach. 0.8mm Tantalum marker balls will be placed at standardised sites on the femur and tibia in all cases. All cemented components will be secured using the same cement. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth.
Follow-up: All patients will be followed up at 0, 3, 6, 12, 24, 60, and 120 months with clinical and radiological assessment. Clinical assessment will involve documentation with the Oxford Knee Score. Patients will undergo radiostereometric analysis and fluoroscopy to study implant migration and occurence of radiolucency, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cementless Oxford Unicompartmental Knee Arthroplasty | Experimental | Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet) |
|
| Cemented Oxford Unicompartmental Knee Arthroplasty | Active Comparator | Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cementless Oxford Unicompartmental Knee Arthroplasty | Device | All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiostereometric Analysis Examination - Translations | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
| Patients will be examined 3 months post surgery. |
| Radiostereometric Analysis Examination - Translations | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
| Patients will be examined 6 months post surgery. |
| Radiostereometric Analysis Examination - Translations | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
| Patients will be examined 12 months post surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David W Murray, MA, MD, FRCS | University of Oxford | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25628280 | Result | Kendrick BJ, Kaptein BL, Valstar ER, Gill HS, Jackson WF, Dodd CA, Price AJ, Murray DW. Cemented versus cementless Oxford unicompartmental knee arthroplasty using radiostereometric analysis: a randomised controlled trial. Bone Joint J. 2015 Feb;97-B(2):185-91. doi: 10.1302/0301-620X.97B2.34331. | |
| 33408039 | Result |
| Label | URL |
|---|---|
| Publication of 2-year results | View source |
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A consecutive series of patients awairing an Oxford Unicompartmental Knee Replacement (OUKR) were invited to participate in the study. Consenting participants received an OUKR between November 2008 and March 2010 at the Nuffield Orthopaedic Centre (Oxford, UK).
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| ID | Title | Description |
|---|---|---|
| FG000 | Cementless Oxford Unicompartmental Knee Arthroplasty | Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet) Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component. |
| FG001 | Cemented Oxford Unicompartmental Knee Arthroplasty | Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet) Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cementless Oxford Unicompartmental Knee Arthroplasty | Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet) Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Radiostereometric Analysis Examination - Translations | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
| Posted | Mean | Standard Deviation | millimetres | Patients will be examined 3 months post surgery. |
|
Adverse event data was collected out to 10 years follow-up.
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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 | Cementless Oxford Unicompartmental Knee Arthroplasty | Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet) Cementless Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant Revision | Surgical and medical procedures | Systematic Assessment | Revision surgery involving the replacement of one or more of the implant components. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mobile Bearing Dislocation | Surgical and medical procedures | Systematic Assessment | Dislocation of the mobile bearing which normally articulates with the femoral and tibial components of the Oxford Unicompartmental Knee Replacement. |
At 10 years, loss to follow-up meant there were less than 16 knees in each group required by the power calculation for the study.
Maximum Total Point Motion (MTPM) was used as an overall indicator of migration, however the utility of MTPM is limited as it compounds measurement errors so tends to overestimate migration.
As the study was powered to detect differences in migration using RSA, the patient numbers were too small to detect differences in clinical outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor David W Murray | University of Oxford, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences | +44 01865 27457 | david.murray@ndorms.ox.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2009 | Feb 13, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 20, 2002 | Feb 13, 2024 | ICF_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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Patients will be randomised to receive either a cementless or cemented Oxford Unicompartmental Knee Arthroplasty.
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|
|
| Cemented Oxford Unicompartmental Knee Arthroplasty | Device | All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement. |
|
|
| Radiostereometric Analysis Examination - Translations | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
| Patients will be examined 24 months post surgery. |
| Radiostereometric Analysis Examination - Translations | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. | Patients will be examined 60 months post surgery. |
| Radiostereometric Analysis Examination - Translations | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
| Patients will be examined 120 months post surgery. |
| Radiostereometric Analysis Examination - Rotations | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: *For the Femoral Component* X Rotation: Positive (+ve) = Increased Flexion; Negative (-ve) = Decreased Flexion Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus *For the Tibial Component* X Rotation: Positive (+ve) = Reduced Slope; Negative (-ve) = Increased Slope Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus | Patients will be examined at 3 months post surgery. |
| Radiostereometric Analysis Examination - Rotations | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
| Patients will be examined at 6 months post surgery. |
| Radiostereometric Analysis Examination - Rotations | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
| Patients will be examined at 12 months post surgery. |
| Radiostereometric Analysis Examination - Rotations | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
| Patients will be examined at 24 months post surgery. |
| Radiostereometric Analysis Examination - Rotations | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
| Patients will be examined at 60 months post surgery. |
| Radiostereometric Analysis Examination - Rotations | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
| Patients will be examined at 120 months post surgery. |
| Radiostereometric Analysis Examination - Maximum Total Point Motion | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres. | Patients will be examined at 3 months post surgery. |
| Radiostereometric Analysis Examination - Maximum Total Point Motion | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres. | Patients will be examined at 12 months post surgery. |
| Radiostereometric Analysis Examination - Maximum Total Point Motion | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres. | Patients will be examined at 24 months post surgery. |
| Radiostereometric Analysis Examination - Maximum Total Point Motion | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres. | Patients will be examined at 60 months post surgery. |
| Radiostereometric Analysis Examination - Maximum Total Point Motion | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres. | Patients will be examined at 120 months post surgery. |
| Radiographic Examination | Fluoroscopic imaging will be used to study the occurence of radiolucencies beneath the components. Anteroposterior radiographs will be analysed to assess the presence and position of radiolucencies. Radiolucencies will be graded as either 'no radiolucency present', 'partial radiolucency', or 'complete radiolucency'. | Patients will be examined at 12 months post surgery. |
| Radiographic Examination | Fluoroscopic imaging will be used to study the occurence of radiolucencies beneath the components. Anteroposterior radiographs will be analysed to assess the presence and position of radiolucencies. Radiolucencies will be graded as either 'no radiolucency present', 'partial radiolucency', or 'complete radiolucency'. | Patients will be examined at 24 months post surgery. |
| Radiographic Examination | Fluoroscopic imaging will be used to study the occurence of radiolucencies beneath the components. Anteroposterior radiographs will be analysed to assess the presence and position of radiolucencies. Radiolucencies will be graded as either 'no radiolucency present', 'partial radiolucency', or 'complete radiolucency'. | Patients will be examined at 60 months post surgery. |
| Radiographic Examination | Fluoroscopic imaging will be used to study the occurence of radiolucencies beneath the components. Anteroposterior radiographs will be analysed to assess the presence and position of radiolucencies. Radiolucencies will be graded as either 'no radiolucency present', 'partial radiolucency', or 'complete radiolucency'. | Patients will be examined at 120 months post surgery. |
| Clinical Assessment | Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best). | Patients will be assessed pre-operatively. |
| Clinical Assessment | Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best). | Patients will be assessed at 12 months post surgery. |
| Clinical Assessment | Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best). | Patients will be assessed at 24 months post surgery. |
| Clinical Assessment | Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best). | Patients will be assessed at 60 months post surgery. |
| Clinical Assessment | Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best). | Patients will be assessed at 120 months post surgery. |
| Radiostereometric Analysis Examination - Maximum Total Point Motion | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres. | Patients will be assessed at 6 months post surgery. |
| Campi S, Kendrick BJL, Kaptein BL, Valstar ER, Jackson WFM, Dodd CAF, Price AJ, Murray DW. Five-year results of a randomised controlled trial comparing cemented and cementless Oxford unicompartmental knee replacement using radiostereometric analysis. Knee. 2021 Jan;28:383-390. doi: 10.1016/j.knee.2020.09.003. Epub 2021 Jan 4. |
| Abstract of the (partial) 10-year results | View source |
| Revision of implant |
|
| Mobile bearing dislocation |
|
| BG001 | Cemented Oxford Unicompartmental Knee Arthroplasty | Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet) Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Cemented Oxford Unicompartmental Knee Arthroplasty | Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet) Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement. |
|
|
| Primary | Radiostereometric Analysis Examination - Translations | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
| Posted | Mean | Standard Deviation | millimetres | Patients will be examined 6 months post surgery. |
|
|
|
| Primary | Radiostereometric Analysis Examination - Translations | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
| Posted | Mean | Standard Deviation | millimetres | Patients will be examined 12 months post surgery. |
|
|
|
| Primary | Radiostereometric Analysis Examination - Translations | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
| Posted | Mean | Standard Deviation | millimetres | Patients will be examined 24 months post surgery. |
|
|
|
| Primary | Radiostereometric Analysis Examination - Translations | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. | Posted | Mean | Standard Deviation | millimetres | Patients will be examined 60 months post surgery. |
|
|
|
| Primary | Radiostereometric Analysis Examination - Translations | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional translations will be measured in millimetres. The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
| 1 Cemented Oxford Unicompartmental Knee Arthroplasty could not be analysed due poor quality stereoradiographs with obstruction of bone markers being obstructed. Consequently, although 15 Cemented Oxford Unicompartmental Knee Arthroplasties were followed-up at 120 months, only 14 could be analysed. | Posted | Mean | Standard Deviation | millimetres | Patients will be examined 120 months post surgery. |
|
|
|
| Primary | Radiostereometric Analysis Examination - Rotations | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as: *For the Femoral Component* X Rotation: Positive (+ve) = Increased Flexion; Negative (-ve) = Decreased Flexion Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus *For the Tibial Component* X Rotation: Positive (+ve) = Reduced Slope; Negative (-ve) = Increased Slope Y Rotation: Positive (+ve) = Internal Rotation; Negative (-ve) = External Rotation Z Rotation: Positive (+ve) = Valgus; Negative (-ve) = Varus | Posted | Mean | Standard Deviation | Degrees | Patients will be examined at 3 months post surgery. |
|
|
|
| Primary | Radiostereometric Analysis Examination - Rotations | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
| Posted | Mean | Standard Deviation | Degrees | Patients will be examined at 6 months post surgery. |
|
|
|
| Primary | Radiostereometric Analysis Examination - Rotations | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
| Posted | Mean | Standard Deviation | Degrees | Patients will be examined at 12 months post surgery. |
|
|
|
| Primary | Radiostereometric Analysis Examination - Rotations | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
| Posted | Mean | Standard Deviation | Degrees | Patients will be examined at 24 months post surgery. |
|
|
|
| Primary | Radiostereometric Analysis Examination - Rotations | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
| Posted | Mean | Standard Deviation | Degrees | Patients will be examined at 60 months post surgery. |
|
|
|
| Primary | Radiostereometric Analysis Examination - Rotations | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Three-dimensional rotations will be measured in degrees.The component position at the post-operative timepoint was used as the baseline for measurement of migration. Migration can be interpreted as:
| 1 Cemented Oxford Unicompartmental Knee Arthroplasty could not be analysed due poor quality stereoradiographs with obstruction of bone markers being obstructed. Consequently, although 15 Cemented Oxford Unicompartmental Knee Arthroplasties were followed-up at 120 months, only 14 could be analysed. | Posted | Mean | Standard Deviation | Degrees | Patients will be examined at 120 months post surgery. |
|
|
|
| Primary | Radiostereometric Analysis Examination - Maximum Total Point Motion | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres. | Posted | Mean | Standard Deviation | millimetres | Patients will be examined at 3 months post surgery. |
|
|
|
| Primary | Radiostereometric Analysis Examination - Maximum Total Point Motion | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres. | Posted | Mean | Standard Deviation | millimetres | Patients will be examined at 12 months post surgery. |
|
|
|
| Primary | Radiostereometric Analysis Examination - Maximum Total Point Motion | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres. | Posted | Mean | Standard Deviation | millimetres | Patients will be examined at 24 months post surgery. |
|
|
|
| Primary | Radiostereometric Analysis Examination - Maximum Total Point Motion | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres. | Posted | Mean | Standard Deviation | millimetres | Patients will be examined at 60 months post surgery. |
|
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| Primary | Radiostereometric Analysis Examination - Maximum Total Point Motion | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres. | 1 Cemented Oxford Unicompartmental Knee Arthroplasty could not be analysed due poor quality stereoradiographs with obstruction of bone markers being obstructed. Consequently, although 15 Cemented Oxford Unicompartmental Knee Arthroplasties were followed-up at 120 months, only 14 could be analysed. | Posted | Mean | Standard Deviation | millimetres | Patients will be examined at 120 months post surgery. |
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| Primary | Radiographic Examination | Fluoroscopic imaging will be used to study the occurence of radiolucencies beneath the components. Anteroposterior radiographs will be analysed to assess the presence and position of radiolucencies. Radiolucencies will be graded as either 'no radiolucency present', 'partial radiolucency', or 'complete radiolucency'. | Posted | Count of Participants | Participants | Patients will be examined at 12 months post surgery. |
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| Primary | Radiographic Examination | Fluoroscopic imaging will be used to study the occurence of radiolucencies beneath the components. Anteroposterior radiographs will be analysed to assess the presence and position of radiolucencies. Radiolucencies will be graded as either 'no radiolucency present', 'partial radiolucency', or 'complete radiolucency'. | Plain radiographs were only available for 21 of the 22 Cementless Oxford Unicompartmental Knee Arthroplasties at the 60 month timepoint, which explains the discrepency between the number of patients analyzed and the number of patients reported in the patient flow. | Posted | Count of Participants | Participants | Patients will be examined at 24 months post surgery. |
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| Primary | Radiographic Examination | Fluoroscopic imaging will be used to study the occurence of radiolucencies beneath the components. Anteroposterior radiographs will be analysed to assess the presence and position of radiolucencies. Radiolucencies will be graded as either 'no radiolucency present', 'partial radiolucency', or 'complete radiolucency'. | Plain radiographs were only available for 18 of the 20 Cemented Oxford Unicompartmental Knee Arthroplasties at the 60 month timepoint, which explains the discrepency between the number of patients analyzed and the number of patients reported in the patient flow. | Posted | Count of Participants | Participants | Patients will be examined at 60 months post surgery. |
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| Primary | Radiographic Examination | Fluoroscopic imaging will be used to study the occurence of radiolucencies beneath the components. Anteroposterior radiographs will be analysed to assess the presence and position of radiolucencies. Radiolucencies will be graded as either 'no radiolucency present', 'partial radiolucency', or 'complete radiolucency'. | Plain radiographs were only available for 15 of the 16 Cementless Oxford Unicompartmental Knee Arthroplasties and 14 of the 15 Cemented Oxford Unicompartmental Knee Arthroplastiesat the 60 month timepoint, which explains the discrepency between the number of patients analyzed and the number of patients reported in the patient flow. | Posted | Count of Participants | Participants | Patients will be examined at 120 months post surgery. |
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| Primary | Clinical Assessment | Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best). | Posted | Mean | Standard Deviation | score on a scale | Patients will be assessed pre-operatively. |
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| Primary | Clinical Assessment | Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best). | Posted | Mean | Full Range | score on a scale | Patients will be assessed at 12 months post surgery. |
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| Primary | Clinical Assessment | Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best). | Posted | Mean | Full Range | score on a scale | Patients will be assessed at 24 months post surgery. |
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| Primary | Clinical Assessment | Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best). | Posted | Mean | Standard Deviation | score on a scale | Patients will be assessed at 60 months post surgery. |
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| Primary | Clinical Assessment | Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best). | Posted | Mean | Standard Deviation | score on a scale | Patients will be assessed at 120 months post surgery. |
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| Primary | Radiostereometric Analysis Examination - Maximum Total Point Motion | Patients will have weight-bearing stereoradiographs. These stereoradiographs will be analysed using model-based radiostereometric analysis which will allow the migration of the components relative to the bone to be determined. Maximum Total Point Motion (MTPM - defined as the length of the translation vector of the point of the component model that has migrated the most) will be measured in millimetres. | Posted | Mean | Standard Deviation | millimetres | Patients will be assessed at 6 months post surgery. |
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| 1 |
| 23 |
| 1 |
| 23 |
| 0 |
| 23 |
| EG001 | Cemented Oxford Unicompartmental Knee Arthroplasty | Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet) Cemented Oxford Unicompartmental Knee Arthroplasty: All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement. | 2 | 24 | 1 | 24 | 1 | 24 |
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Not provided
Not provided
| D012216 |
| Rheumatic Diseases |
| Femoral Z Migration |
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| Tibial X Migration |
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| Tibial Y Migration |
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| Tibial Z Migration |
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| Femoral Z Translation |
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| Tibial X Translation |
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| Tibial Y Translation |
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| Tibial Z Translation |
|
| Femoral Z Translation |
|
| Tibial X Translation |
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| Tibial Y Translation |
|
| Tibial Z Translation |
|
| Femoral Z Translation |
|
| Tibial X Translation |
|
| Tibial Y Translation |
|
| Tibial Z Translation |
|
| Femoral Z Translation |
|
| Tibial X Translation |
|
| Tibial Y Translation |
|
| Tibial Z Translation |
|
| Femoral Z Rotation |
|
| Tibial X Rotation |
|
| Tibial Y Rotation |
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| Tibial Z Rotation |
|
| Femoral Z Rotation |
|
| Tibial X Rotation |
|
| Tibial Y Rotation |
|
| Tibial Z Rotation |
|
| Femoral Z Rotation |
|
| Tibial X Rotation |
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| Tibial Y Rotation |
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| Tibial Z Rotation |
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| Femoral Z Migration |
|
| Tibial X Migration |
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| Tibial Y Migration |
|
| Tibial Z Migration |
|
| Femoral Z Rotation |
|
| Tibial X Rotation |
|
| Tibial Y Rotation |
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| Tibial Z Rotation |
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| Femoral Z Rotation |
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| Tibial X Rotation |
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| Tibial Y Rotation |
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| Tibial Z Rotation |
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| No Radiolucency |
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| Femoral Component |
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| No Radiolucency |
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| Femoral Component |
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| No Radiolucency |
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| Femoral Component |
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| No Radiolucency |
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| Femoral Component |
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