Compare OR resource use and clinical Outcome after Total Knee Arthroplasty using Patient-specific or conventional Instrumentation.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
139
Implantation of a Total Knee Arthroplasty patient-specific instrumentation using Zimmer® NexGen Solutions (Zimmer Biomet, Warsaw, IN).
Implantation of a Total Knee Arthroplasty with conventional using Zimmer® NexGen Solutions (Zimmer Biomet, Warsaw, IN).
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
University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden
Dresden, Saxony, Germany
OR time
Operating Room (OR) time: incision to Close in minutes
Time frame: during surgery
OR resource use: number of instrument trays
OR Efficiency measured by number of instrument trays used
Time frame: during surgery
OR Setup Time
Operating Room (OR) Setup Time in minutes
Time frame: during surgery
Oxford Knee Score
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.
Time frame: 1 year after surgery
visual analog scale (VAS)
patient-reported pain scores as measured by the visual analog scale (VAS), ranging from 0 (worst) to 10 (best).
Time frame: 1 year after surgery
device alignment
device alignment as determined using radiographs (A/P long-standing and lateral films)
Time frame: 1 year after surgery
EQ-5D-3L
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
Time frame: 1 year after surgery
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