Knee Arthroplasty Performed With Conventional and Customized Instrumentation
NCT ID: NCT01124305
Last Updated: 2013-12-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
70 participants
INTERVENTIONAL
2010-05-31
2012-11-30
Brief Summary
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The primary hypothesis is that the use of customized patient instrumentation will reduce the operative time required for total knee arthroplasty.
Detailed Description
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52 patients (26 per group) were enrolled in a prospective, randomized trial comparing CT-based PSI with TI. No difference was seen in average patient age (68 years) or BMI (31) between groups (p=0.84 and p=0.89), although there were more males in the PSI group (14 vs 7, p=0.002). A single surgeon and consistent staff performed the surgeries with the same knee prostheses, and all cases were videotaped to measure the length of surgery and each individual step. Any additional bone cuts, size changes, or ligament releases made to achieve correct alignment and balance were documented. The number of instrument trays opened for each case was recorded. Postoperative long alignment and lateral radiographs were taken to measure the coronal and sagittal plane component alignment and mechanical axis in each patient.
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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Traditional Instrumentation
Control group: Cases performed with traditional surgical instruments
Traditional Instrumentation
Traditional surgical instruments will be used to make bone cuts and size the components in this control group.
Customized Patient Instrumentation
Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
Customized Patient Instrumentation
Custom cutting guides based on computed tomography (CT) images of the patient's leg are used to make the bone cuts and select the implant size.
Interventions
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Customized Patient Instrumentation
Custom cutting guides based on computed tomography (CT) images of the patient's leg are used to make the bone cuts and select the implant size.
Traditional Instrumentation
Traditional surgical instruments will be used to make bone cuts and size the components in this control group.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Previous ipsilateral hip or ankle replacement
* Knee flexion contracture greater than 20 degrees
ALL
No
Sponsors
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Anderson Orthopaedic Research Institute
OTHER
Responsible Party
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Nancy Parks
Knee Project Director
Principal Investigators
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William G Hamilton, MD
Role: PRINCIPAL_INVESTIGATOR
Anderson Orthopaedic Research Institute
Locations
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Anderson Orthopaedic Research Institute
Alexandria, Virginia, United States
Countries
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References
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Lombardi AV Jr, Berend KR, Adams JB. Patient-specific approach in total knee arthroplasty. Orthopedics. 2008 Sep;31(9):927-30. doi: 10.3928/01477447-20080901-21. No abstract available.
Ng VY, DeClaire JH, Berend KR, Gulick BC, Lombardi AV Jr. Improved accuracy of alignment with patient-specific positioning guides compared with manual instrumentation in TKA. Clin Orthop Relat Res. 2012 Jan;470(1):99-107. doi: 10.1007/s11999-011-1996-6.
Howell SM, Kuznik K, Hull ML, Siston RA. Results of an initial experience with custom-fit positioning total knee arthroplasty in a series of 48 patients. Orthopedics. 2008 Sep;31(9):857-63. doi: 10.3928/01477447-20080901-15.
Bali K, Walker P, Bruce W. Custom-fit total knee arthroplasty: our initial experience in 32 knees. J Arthroplasty. 2012 Jun;27(6):1149-54. doi: 10.1016/j.arth.2011.12.006. Epub 2012 Jan 27.
Watters TS, Mather RC 3rd, Browne JA, Berend KR, Lombardi AV Jr, Bolognesi MP. Analysis of procedure-related costs and proposed benefits of using patient-specific approach in total knee arthroplasty. J Surg Orthop Adv. 2011 Summer;20(2):112-6.
Other Identifiers
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AORI2010-0101
Identifier Type: -
Identifier Source: org_study_id