Fully Disposable Patient-Specific Instrumentation

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02966613

Acronym

MyKnee

Enrollment

210

Registered

2016-11-17

Start date

2013-09-30

Completion date

2016-09-30

Last updated

2016-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis,Knee

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).

Interventions

DEVICEGMK Medacta Total Knee arthroplasty

Total Knee arthroplasty

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
% 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026