Clinical Outcome and OR Resource Use of Total Knee Arthroplasty Using Patient-Specific or Conventional Instrumentation
- Conditions
- Gonarthrosis
- Interventions
- Procedure: PSIProcedure: Conventional
- Registration Number
- NCT04114201
- Lead Sponsor
- Technische Universität Dresden
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 139
- 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)
- 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
- Knee deformities greater than 15 degrees of fixed varus, valgus, or flexion contracture on initial physical examination
- An existing condition that would, in the opinion of the investigator, compromise participation or follow-up in this study
- A female who is pregnant or lactating
- Current involvement in any personal injury litigation, medical-legal or worker's compensation claims
- Arterial disease or stents that would exclude the use of a tourniquet
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PSI PSI Patients received TKA using patient-specific Instrumentation. Conventional Conventional Patients received TKA conventional Instrumentation.
- Primary Outcome Measures
Name Time Method OR time during surgery Operating Room (OR) time: incision to Close in minutes
- Secondary Outcome Measures
Name Time Method OR resource use: number of instrument trays during surgery OR Efficiency measured by number of instrument trays used
EQ-5D-3L 1 year after surgery patients' health-related Quality of life is measured by the EQ-5D-3L, which aggregates to a single index where 0 is the worst and 1 is the best outcome
device alignment 1 year after surgery device alignment as determined using radiographs (A/P long-standing and lateral films)
OR Setup Time during surgery Operating Room (OR) Setup Time in minutes
Oxford Knee Score 1 year after surgery clinical outcome measured by the Oxford Knee Scoring System. The Oxford Knee Score is aggregated to a single score where 0 is the worst and 48 is the best Outcome.
visual analog scale (VAS) 1 year after surgery patient-reported pain scores as measured by the visual analog scale (VAS), ranging from 0 (worst) to 10 (best).
Trial Locations
- Locations (3)
University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden
🇩🇪Dresden, Saxony, Germany
Department for Orthopaedic and Trauma Surgery, Schön Klinik Lorsch
🇩🇪Lorsch, Hesse, Germany
Department for Orthopaedic and Trauma Surgery, Helios Kliniken Mittelweser
🇩🇪Nienburg, Lower Saxony, Germany