Cemented vs. Cementless Unicompartmental Knee Arthroplasty

Study Overview
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Brief Summary
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The primary study objective is to evaluate a cementless partial knee system that has a modular 3-D printed porous metal tibial component and a cemented partial knee system. The hypothesis is that at minimum 2-year follow-up, fixed bearing medial partial knee replacements using cementless and cemented fixation will demonstrate no differences in clinical outcome.

Detailed Description
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This is a prospective, randomized, unblinded clinical trial of 100 patients will be enrolled by invitation of the principal investigator. Inclusion criteria include patients 18-85 years old, patients receiving a medial fixed bearing partial knee replacement and patients deemed suitable for both cemented and cementless fixation after review of the preoperative radiographs. Minimum two-year outcome will be analyzed, and long-term follow-up will continue to 5 years.

Official Title
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A Prospective, Randomized Study Comparing Cemented and Cementless Fixed Bearing Unicondylar Medial Knee Replacement

Conditions
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Partial Knee Replacement

Intervention / Treatment
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* Procedure: Cementless fixation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age18-85 years old medial fixed bearing partial knee replacement bone suitable for both cemented and cementless fixation after review of the preoperative radiographs. Exclusion Criteria: Non-English speakers current smokers grossly porotic bone advanced other compartment arthritis at the time of surgery necessitating a total knee arthroplasty (TKA) previous high tibial osteotomy with prior hardware patients who are randomized but are deemed unsuitable to receive the assigned implant by the surgeon due to bone quality or bone cuts

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Interventional Model Description: Prospective randomized trial, unblinded
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cementless<br>Cementless fixation partial knee replacement | Procedure: Cementless fixation<br>* Three dimensional printed porous metal, a biomaterial with morphological and mechanical properties that resemble those of native trabecular bone, is now being used for fixation of the tibial component in unicondylar knee arthroplasty. This can reliably achieve osseointegration into the tibia and could lead to a lower risk of aseptic loosening which is the leading cause of revision in partial knee replacements.<br>|
| Active Comparator: Cemented<br>Cemented fixation partial knee replacement | Procedure: Cementless fixation<br>* Three dimensional printed porous metal, a biomaterial with morphological and mechanical properties that resemble those of native trabecular bone, is now being used for fixation of the tibial component in unicondylar knee arthroplasty. This can reliably achieve osseointegration into the tibia and could lead to a lower risk of aseptic loosening which is the leading cause of revision in partial knee replacements.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score | Clinical score for knee status and function. (0-100 scale, with 0 being the worst score and 100 being the best score.) | 2 years postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, partial knee replacement, cementless