Status:
COMPLETED
Clinical Outcome and OR Resource Use of Total Knee Arthroplasty Using Patient-Specific or Conventional Instrumentation
Lead Sponsor:
Technische Universität Dresden
Collaborating Sponsors:
Zimmer Biomet
Conditions:
Gonarthrosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 2 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2017
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT04114201
Start Date
August 2 2012
End Date
February 23 2017
Last Update
October 3 2019
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Department for Orthopaedic and Trauma Surgery, Schön Klinik Lorsch
Lorsch, Hesse, Germany, 64653
2
Department for Orthopaedic and Trauma Surgery, Helios Kliniken Mittelweser
Nienburg, Lower Saxony, Germany, 31582
3
University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden
Dresden, Saxony, Germany, 01307