Gonarthrosis
Conditions
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.
Interventions
PROCEDUREPSI
Implantation of a Total Knee Arthroplasty patient-specific instrumentation using Zimmer® NexGen Solutions (Zimmer Biomet, Warsaw, IN).
PROCEDUREConventional
Implantation of a Total Knee Arthroplasty with conventional using Zimmer® NexGen Solutions (Zimmer Biomet, Warsaw, IN).
Sponsors
Zimmer Biomet
Technische Universität Dresden
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients were operated consecutively with conventional and patient-specific Instrumentation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OR time | during surgery | Operating Room (OR) time: incision to Close in minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| OR resource use: number of instrument trays | during surgery | OR Efficiency measured by number of instrument trays used |
| device alignment | 1 year after surgery | device alignment as determined using radiographs (A/P long-standing and lateral films) |
| 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 |
| 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). |
Countries
Germany
Outcome results
None listed