The purpose of this prospective study is to evaluate Zimmer® iASSIST™ with respect to radiographic, clinical and economic outcomes and compared to conventional instrumentation in primary total knee arthroplasty (NexGen or Persona knee implants).
The study design is a prospective, multicenter, comparative outcome study. The study requires each site to obtain IRB (Institutional Review Board) approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process. All study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty. Investigators will collect clinical data for 12 months. Follow-up clinical visits include 3 and 12 months post-operatively. The primary endpoint of this study is defined as component alignment as determined using long leg X-Rays. The secondary endpoint will be to evaluate the Knee Society Score, EQ-5D (EuroQol-5Dimensions) scoring system, operating room time, blood loss and complications
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
72
surgical procedure in which damaged parts of the knee joint are replaced with an implant.
Hospital El Angel, S.A.
Málaga, Spain
Hospital Unviersitario Son Espases
Palma de Mallorca, Spain
Universitätsklinik Balgrist
Zurich, Switzerland
Component Alignment
Assess the differences in component alignment, measured by the mean of radiographs, between iASSIST™ and conventional instrumentation in primary total knee arthroplasty (TKA) procedures.
Time frame: 1 year
Knee Society Score Assessment
Assess the differences in Knee Society Score between iASSIST™ and conventional instrumentation in primary TKA procedures. Higher (and better) score value: 100, lower value: 0. Score 80-100 = Excellent Score 70-79 = Good Score 60-69 = Fair Score below 60 = Poor
Time frame: 1 year
Knee Society Score Function
Knee Society Score function asses 12 months postoperatively between iASSIST™ and conventional instrumentation in primary TKA procedures. Higher (and better) score value: 100, lower value: 0. Score 80-100 = Excellent Score 70-79 = Good Score 60-69 = Fair Score below 60 = Poor
Time frame: 1 year
EQ-5D Questionnaire
Assess the differences in EQ-5D between iASSIST™ and conventional instrumentation in primary TKA procedures at 12 months postoperatively. Comparison of the derived EQ-5D scale and health state between the 2 groups. The EQ-5D questionnaire includes five dimensions (5D): mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. EQ-5D values range from -0.2 to 1 where the negative values correspond to bad health states (states worse than death), and 1.0 corresponds to perfect health.
Time frame: 1 year
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