Navigated Total Knee Arthroplasty, the Correlation to CT Scans and Clinical Results
NCT ID: NCT02071745
Last Updated: 2014-02-26
Study Results
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Basic Information
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COMPLETED
70 participants
OBSERVATIONAL
2013-07-31
2014-01-31
Brief Summary
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A successful Total knee arthroplasty(TKA) surgery includes: an accurate alignment( the mechanical axis in axial and rotational planes), as well as significant pain relief which improves function and quality of life. Incorrect alignment can lead to abnormal wear, premature mechanical loosening of the components and patellofemoral problems.
The common techniques for Total knee replacement are:
1. Conventional method TKR
2. CT/MRI-based preoperative navigated TKR
3. Image-free intraoperative navigated TKR In our research we focus on the 3rd method using the Orthopilot navigation system Aesculap®, Tutlingen, Germany. This system is an active PC based guiding system that helps the surgeon decide on the accurate alignment and orientation of the implant and cutting surfaces of the bone and thus avoid incorrect alignment.
We aim to compare between pre-operative and post-operative lower limb alignment (mechanical axis) in Aesculap based TKA using serview CT. Furthermore, we will try to examine the existence of a correlation between the CT scans and the Orthopilot navigation system output and assess the clinical outcome of the patient postoperatively.
Our Hypothesis is that the intra-operative navigation system is accurate and correlated to CT images results, moreover, allows the surgeon to achieve a good mechanical axis and high clinical outcome,
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Navigation
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* severe osteoarthrosis of the knee
* failure of conservative treatment.
Exclusion Criteria
* secondary knee deformation due to muscular atrophy or disease
* active infection
* morbid obesity
* neuropathic knee and osteomyelitis.
18 Years
90 Years
ALL
No
Sponsors
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Ziv Hospital
OTHER_GOV
Responsible Party
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David Eliya Rothem
MD
Principal Investigators
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David E Rothem, MD
Role: PRINCIPAL_INVESTIGATOR
Head of joint repalcement unit, Orthopedic department, Ziv medical center, Safed, Israel
Locations
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ZIV medical center
Safed, , Israel
Countries
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References
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Mason JB, Fehring T, Fahrbach K. Navigated total knee replacement. J Bone Joint Surg Am. 2007 Nov;89(11):2547-8; author reply 2548; discussion 2548-50. doi: 10.2106/00004623-200711000-00032. No abstract available.
Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
Oswald MH, Jakob RP, Schneider E, Hoogewoud HM. Radiological analysis of normal axial alignment of femur and tibia in view of total knee arthroplasty. J Arthroplasty. 1993 Aug;8(4):419-26. doi: 10.1016/s0883-5403(06)80042-2.
Wasielewski RC, Galante JO, Leighty RM, Natarajan RN, Rosenberg AG. Wear patterns on retrieved polyethylene tibial inserts and their relationship to technical considerations during total knee arthroplasty. Clin Orthop Relat Res. 1994 Feb;(299):31-43.
Bargren JH, Blaha JD, Freeman MA. Alignment in total knee arthroplasty. Correlated biomechanical and clinical observations. Clin Orthop Relat Res. 1983 Mar;(173):178-83.
Berger RA, Rubash HE, Seel MJ, Thompson WH, Crossett LS. Determining the rotational alignment of the femoral component in total knee arthroplasty using the epicondylar axis. Clin Orthop Relat Res. 1993 Jan;(286):40-7.
Other Identifiers
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ZIV-0041-13
Identifier Type: -
Identifier Source: org_study_id
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