Clinical Outcome and OR Resource Use of Total Knee Arthroplasty Using Patient-Specific or Conventional Instrumentation
NCT ID: NCT04114201
Last Updated: 2019-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
139 participants
INTERVENTIONAL
2012-08-02
2017-02-23
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PSI
Patients received TKA using patient-specific Instrumentation.
PSI
Implantation of a Total Knee Arthroplasty patient-specific instrumentation using Zimmer® NexGen Solutions (Zimmer Biomet, Warsaw, IN).
Conventional
Patients received TKA conventional Instrumentation.
Conventional
Implantation of a Total Knee Arthroplasty with conventional using Zimmer® NexGen Solutions (Zimmer Biomet, Warsaw, IN).
Interventions
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PSI
Implantation of a Total Knee Arthroplasty patient-specific instrumentation using Zimmer® NexGen Solutions (Zimmer Biomet, Warsaw, IN).
Conventional
Implantation of a Total Knee Arthroplasty with conventional using Zimmer® NexGen Solutions (Zimmer Biomet, Warsaw, IN).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Technische Universität Dresden
OTHER
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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TKA-PSI
Identifier Type: -
Identifier Source: org_study_id
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