Fully Disposable Patient-Specific Instrumentation (MyKnee)

Cochin Hospital

Status: Completed

Conditions: Osteoarthritis,Knee

Treatments: Device: GMK Medacta Total Knee arthroplasty

Study type: Interventional

Identifiers

NCT02966613

SC2900

Details and patient eligibility

About

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

Full 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).

Enrollment: 210 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

210 participants in 3 patient groups

CI

Active Comparator group

Description:

TKA using conventional instrumentation (CI)

Treatment:

Device: GMK Medacta Total Knee arthroplasty

PSCG

Experimental group

Description:

TKA performed using Patient specific cutting guides (PSCG)

Treatment:

Device: GMK Medacta Total Knee arthroplasty

PSCG-D

Experimental group

Description:

TKA performed using fully disposable Patient specific cutting guides (PSCG-D)

Treatment:

Device: GMK Medacta Total Knee arthroplasty