Fully Disposable Patient-Specific Instrumentation

Osteoarthritis,Knee Clinical Trial

— MyKnee  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02966613
• Other study ID #: SC2900
• Status: Completed
• Phase: N/A
• First received: September 26, 2016
• Last updated: November 15, 2016
• Start date: September 2013
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: Cochin Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Commission nationale de l'informatique et des libertés
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: September 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Osteoarthritis,Knee

Intervention

Device:
• GMK Medacta Total Knee arthroplasty
Total Knee arthroplasty

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cochin Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	% outliers	% of patients with an HKA angle outside 180°+/- 3°	3 months	No
Secondary	Knee Society Score	Validated pain and function score following TKA	3 months	No
Secondary	Oxford Knee Score	Patients self assessment of knee function	3 months	No