Patient-Specific Versus Conventional Instrumentation in TKA

Osteoarthritis, Knee Clinical Trial

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Official title:

RCT Multicenter Comparison of Patient-Specific Versus Conventional Instrumentation in Primary TKA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02002624
• Other study ID #: CCP SC 2837
• Status: Completed
• Phase: N/A
• First received: December 1, 2013
• Last updated: December 5, 2013
• Start date: September 2011
• Est. completion date: July 2013

Study information

• Verified date: December 2013
• Source: Cochin Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Haute Autorité de Santé Transparency Commission
• Study type: Interventional

Clinical Trial Summary

The aim of this prospective multicenter randomized clinical trial (RCT) is to compare the clinical and radiologic results of primary total knee arthroplasty (TKA) using patient-specific versus conventional instrumentation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• patients with primary or secondary osteoarthritis of the knee requiring total knee arthroplasty

• 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

• presence of hardware that could artifact MRI

• contraindication to MRI

• 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, Knee

Intervention

Device:
• PSI

• Conventional instrumentation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cochin Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood loss	According to Mercuriali et al.	5 days	No
Primary	Mechanical axis	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 HKA (hip-knee-ankle) 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	Components position	Also, components position in the coronal plane was measured on both the tibial and femoral sides by the femoral (F) angle between the tangent line of the distal prosthetic condyles and the mechanical axis of the femur, and by the tibial (T) angle between the tangent line of the prosthetic tibial baseplate and the mechanical axis of the tibia. In addition in the sagittal plane, tibial slope (TS) was measured by the angle between the tangent of the tibial baseplate and the posterior cortex of the tibia on a lateral view of the knee made at three-month follow-up.	3 months	No