Fully Disposable Patient-Specific Instrumentation

Not Applicable

Completed

• Conditions: Osteoarthritis,Knee
• Interventions: Device: GMK Medacta Total Knee arthroplasty

• Registration Number: NCT02966613
• Lead Sponsor: Cochin Hospital

Brief Summary

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

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).

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2015-12
• Study Completion: 2016-09
• Study First Submitted: 2016-09-26
• Status Verified: 2016-11
• Study First Submitted QC: 2016-11-15
• Last Update Submitted: 2016-11-15
• Study First Posted: 2016-11-17
• Last Update Posted: 2016-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CI	GMK Medacta Total Knee arthroplasty	TKA using conventional instrumentation (CI)
PSCG	GMK Medacta Total Knee arthroplasty	TKA performed using Patient specific cutting guides (PSCG)
PSCG-D	GMK Medacta Total Knee arthroplasty	TKA performed using fully disposable Patient specific cutting guides (PSCG-D)

Primary Outcome Measures

Name	Time	Method
HKA angle	3 months	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.

Secondary Outcome Measures

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