Fully Disposable Patient-Specific Instrumentation

Study Overview
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Brief Summary
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To evaluate the lower limb alignment following total knee arthroplasty (TKA) performed with fully disposable patient-specific instrumentation versus conventional, versus patient specific instrumentation.

Detailed Description
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The investigators performed a controlled multicenter trial comparing the clinical and radiologic results and resources consumption of primary TKA using patient-specific cutting guides (PSCG) versus conventional instrumentation (CI), and compared the results to those obtained with a fully disposable patient-specific instrumentation (PSCG-D).

Official Title
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Primary TKA Using a Fully Disposable Patient-Specific Instrumentation: A Multicenter Controlled Study

Conditions
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Osteoarthritis,Knee

Intervention / Treatment
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* Device: GMK Medacta Total Knee arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients aged between 18 and 85 years able to understand information affiliated to social security Exclusion Criteria: active or suspected sepsis tumor around the knee previous partial or total knee replacement extra-articular deformation requiring osteotomy around the knee in conjunction with TKA social situation that could impair follow-up

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CI<br>TKA using conventional instrumentation (CI) | Device: GMK Medacta Total Knee arthroplasty<br>* Total Knee arthroplasty<br>|
| Experimental: PSCG<br>TKA performed using Patient specific cutting guides (PSCG) | Device: GMK Medacta Total Knee arthroplasty<br>* Total Knee arthroplasty<br>|
| Experimental: PSCG-D<br>TKA performed using fully disposable Patient specific cutting guides (PSCG-D) | Device: GMK Medacta Total Knee arthroplasty<br>* Total Knee arthroplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HKA angle | Lower limb mechanical axis was measured on a bipodal standing leg-length anteroposterior radiograph with the patella oriented straight made three months postoperatively, using Roman software version 1.70 (Oswestry, United Kingdom). Postoperative lower limb mechanical axis was calculated from the Hip-Knee-Ankle (HKA) angle between the femoral and tibial mechanical axes, respectively. An HKA angle greater than 180° was indicative of valgus, whereas values lower than 180° indicated varus. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % outliers | % of patients with an HKA angle outside 180°+/- 3° | 3 months | 
| Knee Society Score | Validated pain and function score following TKA | 3 months | 
| Oxford Knee Score | Patients self assessment of knee function | 3 months |