Evaluation of Zimmer® Patient Specific Instrumentation vs. Conventional Instrumentation in Total Knee Arthroplasty Procedures: Clinical and Economic Outcomes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gonarthrosis
- Sponsor
- Technische Universität Dresden
- Enrollment
- 139
- Locations
- 3
- Primary Endpoint
- OR time
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Compare OR resource use and clinical Outcome after Total Knee Arthroplasty using Patient-specific or conventional Instrumentation.
Detailed Description
The aim of this study was to compare OR resource use and clinical Outcome after Total Knee Arthroplasty (TKA) using Patient-specific (PSI) or conventional Instrumentation. For this purpose, economic variables of the surgery (number of instrument trays, setup and cut-sew-time), radiological alignment and patient reported outcomes (VAS Pain Scale, Oxford Knee Score, EQ-5D) were assessed. Cost per QALY (quality-adjusted life year) was assessed using the German DRG reimbursement and the EQ-5D. A total of 139 TKA with PSI or conventional instrumentation were included in three Centers and were assessed before surgery, as well as 6 weeks, 6 and 12 months postoperatively.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Painful, disabled knee joint resulting from osteoarthritis requiring primary TKA
- •Informed Consent: Patient has signed a "Patient Informed Consent.
- •Able and willing to undergo a preoperative MRI scan (for PSI cases) and full-leg, standing radiographs (all cases)
- •Able and willing to follow instructions and complete follow-up
- •Patient receiving Zimmer NexGen Solutions CR-Flex (including Gender Solutions)
Exclusion Criteria
- •Patient is skeletally immature
- •Active Infection (including septic knee, distant infection, or osteomyelitis)
- •Severe hip arthrosis
- •Neurological disorders (including, but not limited to Parkinson's disease)
- •Prior unicompartmental knee arthroplasty, TKA, knee fusion or patellectomy
- •Hip or knee ankylosis
- •Either rheumatoid or post-traumatic knee arthritis
- •Scheduled for simultaneous bilateral TKA
- •Indications of intra- and/or extra-articular deformations that would inhibit the use of PSI guides
- •Any metal within 150 mm of the joint line for the operative-side knee
Outcomes
Primary Outcomes
OR time
Time Frame: during surgery
Operating Room (OR) time: incision to Close in minutes
Secondary Outcomes
- OR resource use: number of instrument trays(during surgery)
- EQ-5D-3L(1 year after surgery)
- device alignment(1 year after surgery)
- OR Setup Time(during surgery)
- Oxford Knee Score(1 year after surgery)
- visual analog scale (VAS)(1 year after surgery)