Arthritis Clinical Trial
Official title:
Is Clinical Outcome of Robotic-Assisted TKA Better Than Conventional Manual TKA?Prospective, Randomized Study
NCT number | NCT03659318 |
Other study ID # | RoboTKA |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | January 2002 |
Est. completion date | July 2018 |
Verified date | July 2019 |
Source | Ewha Womans University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Robotic-assisted total knee arthroplasty (TKA) was introduced to attempt to enhance the precision of bone preparation, component alignment and ultimately improve clinical results and survivorship of TKA. Although several published data suggest that bone preparation, and knee component alignment were improved by using robotic assistance, there is no high-quality evidence from randomized trials at long-term of which investigators are aware evaluating whether the improved bone preparation and knee component alignment improved clinical function or longevity of the TKA.
Status | Completed |
Enrollment | 674 |
Est. completion date | July 2018 |
Est. primary completion date | February 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility |
Inclusion Criteria: - end stage knee arthritis Exclusion Criteria: - mild knee deformity - inflammatory arthritis - foot and ankle disorder - dementia - hip disease - history of a stroke - older than 65 years of age |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ewha Womans University |
Arima J, Whiteside LA, McCarthy DS, White SE. Femoral rotational alignment, based on the anteroposterior axis, in total knee arthroplasty in a valgus knee. A technical note. J Bone Joint Surg Am. 1995 Sep;77(9):1331-4. — View Citation
Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40. — View Citation
Bellemans J, Vandenneucker H, Vanlauwe J. Robot-assisted total knee arthroplasty. Clin Orthop Relat Res. 2007 Nov;464:111-6. — View Citation
Crowder AR, Duffy GP, Trousdale RT. Long-term results of total knee arthroplasty in young patients with rheumatoid arthritis. J Arthroplasty. 2005 Oct;20(7 Suppl 3):12-6. — View Citation
Decking J, Theis C, Achenbach T, Roth E, Nafe B, Eckardt A. Robotic total knee arthroplasty: the accuracy of CT-based component placement. Acta Orthop Scand. 2004 Oct;75(5):573-9. — View Citation
Jacofsky DJ, Allen M. Robotics in Arthroplasty: A Comprehensive Review. J Arthroplasty. 2016 Oct;31(10):2353-63. doi: 10.1016/j.arth.2016.05.026. Epub 2016 May 18. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Knee society Knee score | a proven score for the measurement of knee function, the score ranges from 0 to 100, 100 being the best possible score, indicating normal knee function | 20 years after the surgery | |
Secondary | WOMAC score | A tool to evaluate patient function associated with knee. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). The total score is summed from individual sections, and 0 is the best possible score. | 20 years after the surgery |
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