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Cemented Versus Cementless Unicompartmental Knee Arthroplasty

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cementless Oxford Unicompartmental Knee Arthroplasty
Cemented Oxford Unicompartmental Knee Arthroplasty
Sponsored by
Oxford University Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Knee Arthroplasty, Unicompartmental, Fixation, Radiostereometric Analysis

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Healthy Subjects with osteoarthritis of knee fulfilling the standard indications for an Oxford Unicompartmental Knee Replacement. American Society of Anaesthesiologists (ASA) Score of 1 to 3. Exclusion Criteria: Subjects with severe limiting systemic illness (i.e. ASA > 3). Subjects who are too large for radiostereometric analysis to be carried out. Subjects who have had previous open surgery or anterior cruciate ligament (ACL) reconstruction on the same knee.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Cementless Oxford Unicompartmental Knee Arthroplasty

    Cemented Oxford Unicompartmental Knee Arthroplasty

    Arm Description

    Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)

    Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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'.
    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'.
    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'.
    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'.
    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'.
    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'.
    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'.
    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).
    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).
    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).
    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).
    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).

    Secondary Outcome Measures

    Full Information

    First Posted
    June 8, 2023
    Last Updated
    July 6, 2023
    Sponsor
    Oxford University Hospitals NHS Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05935878
    Brief Title
    Cemented Versus Cementless Unicompartmental Knee Arthroplasty
    Official Title
    Cemented Versus Cementless Unicompartmental Knee Arthroplasty (UKA) - A Single-blind Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    November 8, 2002 (Actual)
    Primary Completion Date
    March 21, 2011 (Actual)
    Study Completion Date
    March 11, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Oxford University Hospitals NHS Trust

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Knee
    Keywords
    Knee Arthroplasty, Unicompartmental, Fixation, Radiostereometric Analysis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients will be randomised to receive either a cementless or cemented Oxford Unicompartmental Knee Arthroplasty.
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    47 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cementless Oxford Unicompartmental Knee Arthroplasty
    Arm Type
    Experimental
    Arm Description
    Phase III Cementless Oxford Unicompartmental Knee Replacement (Biomet)
    Arm Title
    Cemented Oxford Unicompartmental Knee Arthroplasty
    Arm Type
    Active Comparator
    Arm Description
    Phase III Cemented Oxford Unicompartmental Knee Replacement (Biomet)
    Intervention Type
    Device
    Intervention Name(s)
    Cementless Oxford Unicompartmental Knee Arthroplasty
    Other Intervention Name(s)
    Cementless Oxford Unicompartmental Knee Replacement
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Cemented Oxford Unicompartmental Knee Arthroplasty
    Other Intervention Name(s)
    Cemented Oxford Unicompartmental Knee Replacement
    Intervention Description
    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 Outcome Measure Information:
    Title
    Radiostereometric Analysis Examination - Translations
    Description
    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.
    Time Frame
    Patients will be examined immediately (0 months) post surgery.
    Title
    Radiostereometric Analysis Examination - Translations
    Description
    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.
    Time Frame
    Patients will be examined 3 months post surgery.
    Title
    Radiostereometric Analysis Examination - Translations
    Description
    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.
    Time Frame
    Patients will be examined 6 months post surgery.
    Title
    Radiostereometric Analysis Examination - Translations
    Description
    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.
    Time Frame
    Patients will be examined 12 months post surgery.
    Title
    Radiostereometric Analysis Examination - Translations
    Description
    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.
    Time Frame
    Patients will be examined 24 months post surgery.
    Title
    Radiostereometric Analysis Examination - Translations
    Description
    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.
    Time Frame
    Patients will be examined 60 months post surgery.
    Title
    Radiostereometric Analysis Examination - Translations
    Description
    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.
    Time Frame
    Patients will be examined 120 months post surgery.
    Title
    Radiostereometric Analysis Examination - Rotations
    Description
    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.
    Time Frame
    Patients will be examined immediately (0 months) post surgery.
    Title
    Radiostereometric Analysis Examination - Rotations
    Description
    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.
    Time Frame
    Patients will be examined at 3 months post surgery.
    Title
    Radiostereometric Analysis Examination - Rotations
    Description
    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.
    Time Frame
    Patients will be examined at 6 months post surgery.
    Title
    Radiostereometric Analysis Examination - Rotations
    Description
    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.
    Time Frame
    Patients will be examined at 12 months post surgery.
    Title
    Radiostereometric Analysis Examination - Rotations
    Description
    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.
    Time Frame
    Patients will be examined at 24 months post surgery.
    Title
    Radiostereometric Analysis Examination - Rotations
    Description
    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.
    Time Frame
    Patients will be examined at 60 months post surgery.
    Title
    Radiostereometric Analysis Examination - Rotations
    Description
    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.
    Time Frame
    Patients will be examined at 120 months post surgery.
    Title
    Radiostereometric Analysis Examination - Maximum Total Point Motion
    Description
    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.
    Time Frame
    Patients will be examined immediately (0 months) post surgery.
    Title
    Radiostereometric Analysis Examination - Maximum Total Point Motion
    Description
    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.
    Time Frame
    Patients will be examined at 3 months post surgery.
    Title
    Radiostereometric Analysis Examination - Maximum Total Point Motion
    Description
    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.
    Time Frame
    Patients will be examined at 6 months post surgery.
    Title
    Radiostereometric Analysis Examination - Maximum Total Point Motion
    Description
    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.
    Time Frame
    Patients will be examined at 12 months post surgery.
    Title
    Radiostereometric Analysis Examination - Maximum Total Point Motion
    Description
    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.
    Time Frame
    Patients will be examined at 24 months post surgery.
    Title
    Radiostereometric Analysis Examination - Maximum Total Point Motion
    Description
    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.
    Time Frame
    Patients will be examined at 60 months post surgery.
    Title
    Radiostereometric Analysis Examination - Maximum Total Point Motion
    Description
    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.
    Time Frame
    Patients will be examined at 120 months post surgery.
    Title
    Radiographic Examination
    Description
    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'.
    Time Frame
    Patients will be examined immediately (0 months) post surgery.
    Title
    Radiographic Examination
    Description
    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'.
    Time Frame
    Patients will be examined at 3 months post surgery.
    Title
    Radiographic Examination
    Description
    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'.
    Time Frame
    Patients will be examined at 6 months post surgery.
    Title
    Radiographic Examination
    Description
    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'.
    Time Frame
    Patients will be examined at 12 months post surgery.
    Title
    Radiographic Examination
    Description
    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'.
    Time Frame
    Patients will be examined at 24 months post surgery.
    Title
    Radiographic Examination
    Description
    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'.
    Time Frame
    Patients will be examined at 60 months post surgery.
    Title
    Radiographic Examination
    Description
    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'.
    Time Frame
    Patients will be examined at 120 months post surgery.
    Title
    Clinical Assessment
    Description
    Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best).
    Time Frame
    Patients will be assessed pre-operatively.
    Title
    Clinical Assessment
    Description
    Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best).
    Time Frame
    Patients will be assessed at 12 months post surgery.
    Title
    Clinical Assessment
    Description
    Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best).
    Time Frame
    Patients will be assessed at 24 months post surgery.
    Title
    Clinical Assessment
    Description
    Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best).
    Time Frame
    Patients will be assessed at 60 months post surgery.
    Title
    Clinical Assessment
    Description
    Clinical assessment will involve documentation with the Oxford Knee Score. The score will be calculated on a scale of 0 (worst) to 48 (best).
    Time Frame
    Patients will be assessed at 120 months post surgery.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Healthy Subjects with osteoarthritis of knee fulfilling the standard indications for an Oxford Unicompartmental Knee Replacement. American Society of Anaesthesiologists (ASA) Score of 1 to 3. Exclusion Criteria: Subjects with severe limiting systemic illness (i.e. ASA > 3). Subjects who are too large for radiostereometric analysis to be carried out. Subjects who have had previous open surgery or anterior cruciate ligament (ACL) reconstruction on the same knee.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David W Murray, MA, MD, FRCS
    Organizational Affiliation
    University of Oxford
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25628280
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    33408039
    Citation
    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.
    Results Reference
    result
    Links:
    URL
    https://boneandjoint.org.uk/article/10.1302/0301-620X.97B2.34331
    Description
    Publication of 2-year results
    URL
    https://boneandjoint.org.uk/Article/10.1302/1358-992X.2022.7.086
    Description
    Abstract of the (partial) 10-year results

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    Cemented Versus Cementless Unicompartmental Knee Arthroplasty

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