Prospective Randomized Trial of Navigated and Conventional TKA
NCT ID: NCT01022099
Last Updated: 2009-12-18
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
80 participants
INTERVENTIONAL
2006-01-31
2008-12-31
Brief Summary
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Detailed Description
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A full-length standing and a lateral radiograph as well as CT scans of the hip, knee and ankle joint were performed 5 to 7 days postoperatively before discharge.
2. clinical outcome Patient sociodemographic and anamnestic data were collected. The written interview was complemented by the EuroQol questionnaire (release EQ-5D) and the assessment of the patients' functional status (Knee Society Score) one week before surgery and 18 to 24 month after surgery.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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navigated TKA
Implantation of a Total Knee Arthroplasty
In all patients a cemented, unconstrained, cruciate-retaining TKA with a rotating platform (ScorpioTM PCS, Stryker Orthopaedics, Mahwah, NJ) was implanted. No patellar resurfacing was performed. A medial parapatellar approach with a femur-first preparation was done in all cases.
The Stryker Navigation System, Knee Navigation Software V3.1 (Stryker Orthopaedics, Mahwah, NJ) was used for computer-assisted implantation.
The conventional implantation was performed with femoral intramedullary and tibial extramedullary standard alignment guides.
conventional TKA
Implantation of a Total Knee Arthroplasty
In all patients a cemented, unconstrained, cruciate-retaining TKA with a rotating platform (ScorpioTM PCS, Stryker Orthopaedics, Mahwah, NJ) was implanted. No patellar resurfacing was performed. A medial parapatellar approach with a femur-first preparation was done in all cases.
The Stryker Navigation System, Knee Navigation Software V3.1 (Stryker Orthopaedics, Mahwah, NJ) was used for computer-assisted implantation.
The conventional implantation was performed with femoral intramedullary and tibial extramedullary standard alignment guides.
Interventions
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Implantation of a Total Knee Arthroplasty
In all patients a cemented, unconstrained, cruciate-retaining TKA with a rotating platform (ScorpioTM PCS, Stryker Orthopaedics, Mahwah, NJ) was implanted. No patellar resurfacing was performed. A medial parapatellar approach with a femur-first preparation was done in all cases.
The Stryker Navigation System, Knee Navigation Software V3.1 (Stryker Orthopaedics, Mahwah, NJ) was used for computer-assisted implantation.
The conventional implantation was performed with femoral intramedullary and tibial extramedullary standard alignment guides.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* indication to TKA
* a mechanical axis between 20° varus and 5° valgus
* signed informed consent
Exclusion Criteria
* severe instability that could not be treated with an unconstrained, cruciate-retaining TKA
50 Years
ALL
No
Sponsors
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Technische Universität Dresden
OTHER
Responsible Party
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Dresden University of Technology
Principal Investigators
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Klaus-Peter Günther, MD, PhD
Role: STUDY_DIRECTOR
Orthopaedic Department, University Hospital Dresden
Locations
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University Hospital Dresden, Orthopaedic Department
Dresden, , Germany
Countries
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References
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Lutzner J, Krummenauer F, Wolf C, Gunther KP, Kirschner S. Computer-assisted and conventional total knee replacement: a comparative, prospective, randomised study with radiological and CT evaluation. J Bone Joint Surg Br. 2008 Aug;90(8):1039-44. doi: 10.1302/0301-620X.90B8.20553.
Beyer F, Pape A, Lutzner C, Kirschner S, Lutzner J. Similar outcomes in computer-assisted and conventional total knee arthroplasty: ten-year results of a prospective randomized study. BMC Musculoskelet Disord. 2021 Aug 18;22(1):707. doi: 10.1186/s12891-021-04556-3.
Harman MK, Banks SA, Kirschner S, Lutzner J. Prosthesis alignment affects axial rotation motion after total knee replacement: a prospective in vivo study combining computed tomography and fluoroscopic evaluations. BMC Musculoskelet Disord. 2012 Oct 23;13:206. doi: 10.1186/1471-2474-13-206.
Lutzner J, Krummenauer F, Gunther KP, Kirschner S. Rotational alignment of the tibial component in total knee arthroplasty is better at the medial third of tibial tuberosity than at the medial border. BMC Musculoskelet Disord. 2010 Mar 25;11:57. doi: 10.1186/1471-2474-11-57.
Other Identifiers
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KneeNavy
Identifier Type: -
Identifier Source: org_study_id