Oxford Partial Knee Replacement. A Randomized Clinical Trial of Three Implant Types

Study Overview
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Brief Summary
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The purpose of this scientific study is to clarify whether there is a relationship between the appearance of radiolucent lines in bone-cement interphase of the tibial component of the different models of the Oxford Uni Knee prosthesis and poor prognosis of these prostheses. This will be accomplished in a se-ries of three different Oxford Uni Knees.

Detailed Description
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The purpose of this scientific study is to clarify whether there is a relationship between the appearance of radiolucent lines in bone-cement interphase of the tibial component of the different models of the Oxford Uni Knee prosthesis and poor prognosis of these prostheses. This will be accomplished in a series of three different Oxford Uni Knees by studying: Three way randomized comparison of migration (prosthetic fixation) by Model Based RSA with three different Oxford Uni Knee prosthesis (both tibial trays and femoral components will be assessed). Fluoroscopy (screening) roentgenograms for determination of RLL around the tibial component and overhang of the tibial trays. Changes in periprosthetic bone mineral density between the three randomized groups evaluated in the proximal tibia and distal femur on the surgical side and on the unaffected tibial condyle area (BMD). Clinical function of the Uni Knee evaluated by a score system using a recent Danish adaptation of the Oxford Knee Score that consists of a questionnaire filled-out by the patient with 12 simple questions on pre-and postoperative assessment of the ADL. Analysis of wear of the mobile polyethylene (meniscus) including a methodical study as to whether the technique requires weightbearing (standing) stereoroentgenograms or whether non-weightbearing stereoroentgenograms can be used (assessed with Model Based RSA). If a fast bone-remodeling increases the risk of aseptic loosening (histomorphometric results combined with RSA results and possible revision) Increased risk of aseptic loosening with cemented (two designs) compared to uncemented im-plants. If bone-remodeling of the proximal tibia is dependent on gender and age. The study would be considered a success if all designs of the prostheses are firmly fixed and remain so during the entire period of study, that is, no increasing migration is seen using RSA. It would be a success if the appearance of RLL beneath the implant in the proximal tibia is unrelated to bone loss and prosthesis migration. The hypotheses are: RLL in relation to the tibial component is unimportant for fixation of the Oxford Uni Knee as assessed with DEXA and RSA. There is very little wear of the polyethylene in the course of a 5 year follow-up as assessed with RSA. The femoral component is expected to remain fixed throughout the entire period of follow-up. Function assessment as ROM (range of motion) after UKA is satisfactory and generally better than after TKA. All three prosthetic designs are expected to migrate minimally and remain fixed throughout the follow-up period, but the uncemented design is expected to be superior to the cemented design. No difference in clinical outcome between the three prosthetic types. The bone-remodeling rate in the medial periarticular tibia bone increases the risk of aseptic loosening. The primary parameters of effect are RLL, RSA and DEXA. The secondary parameters of effect are bone-remodeling, wear analysis, Oxford Knee Score (ADL) and ROM.

Official Title
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Oxford Partial Knee Replacement: A Randomized Clinical Trial of Three Implant Types.

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: Oxford Uni Knee
* Device: Oxford Uni Knee
* Device: Oxford Uni Knee


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients, both men and women, with anteromedial unicompartmental knee osteoarthritis Patients found suitable for UKA with telos stress-radiographs Patients with sufficient bone quality to allow insertion of a Uni Knee prosthesis Patellofemoral osteoarthritis is not a contraindication if the patient does not have symptoms from the patellofemoral joint Patients can only take part in one knee study All age groups, in good condition and responsible adults Informed, written compliance consent. Exclusion Criteria: Patients with neuromuscular or vascular diseases in the affected leg Patients found to be unsuitable for UKA before or at surgery Preoperative extensions defect greater than 10 degrees Preoperative maximal flection of less than 100 degrees Symptomatic patellofemoral osteoarthritis Insufficiency with regard to ACL Patients templated to a size XS or XL femoral component prior to surgery. Patients with osteoporosis on the basis of preoperative x-rays or earlier diagnosis Continuous medical treatment with vitamin K antagonist (Warfarin), known to reduce bone mass in general by a factor of 5 Patients with fracture sequelae (intraarticular fracture and all tibial condyle fractures) Patients previous having PTO or other extensive knee surgery Patients with metabolic bone disease Patients with rheumatoid arthritis Postmenopausal female patients being treated with systemic hormonal substitution (not taking into local vaginal treatment) Patients who intermittently or continuously require treatment with systemic glucocorticoids Non-Danish citizens Insufficient command of the Danish language (read and speak) Senile dementia Misuse of drugs or Alcohol Serious psychiatric illness Disseminated malignant disease (cancer) and treatment with radiation or chemotherapy Serious systemic disease (e.g.. hemiparesis and severe Parkinsonism) Systemic hip or back condition Employed by the department of orthopaedic surgery On-going case involving work injury of the knee Patients with poor dental status

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Cemented single pegged femur with standard tibial bearing tray | Device: Oxford Uni Knee<br>* Oxford Uni Knee inserted at the time of surgery<br>* Other names: Biomet, Oxford Uni Knee,standard tibial bearing tray;|
| Active Comparator: 2<br>Cemented twin pegged femur with standard tibial bearing tray | Device: Oxford Uni Knee<br>* Oxford Uni Knee inserted at the time of surgery<br>* Other names: Biomet, Oxford Uni Knee, standard tibial bearing tray;|
| Active Comparator: 3<br>Cementless tibial bearing tray and femur (porous coated and HA coated) | Device: Oxford Uni Knee<br>* Oxford Uni Knee inserted at the time of surgery (porous coated and HA coated)<br>* Other names: Biomet, Oxford Uni Knee, cementless tibial bearing tray;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Three way randomized comparison of migration (prosthetic fixation) by Model Based RSA with three different Oxford Uni Knee prosthesis (both tibial trays and femoral components will be assessed) |  | 2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluoroscopy (screening) roentgenograms for determination of RLL around the tibial component and overhang of the tibial trays. |  | 2016 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RSA, Unicompartmental osteoarthrosis, Bone-remodelling