RCT Multicenter Comparison of Patient-Specific Versus Conventional Instrumentation in Primary TKA
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cochin Hospital
- Enrollment
- 140
- Primary Endpoint
- Mechanical axis
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Conventional
Conventional instrumentation
Intervention: Conventional instrumentation (Device)
PSI
Patient specific instrumentation
Intervention: PSI (Device)
Outcomes
Primary Outcomes
Mechanical axis
Time Frame: 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 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.
Secondary Outcomes
- Components position(3 months)
Investigators
Moussa Hamadouche
MD, PhD
Cochin Hospital