Robotic-Assisted Versus Conventional Total Knee Arthroplasty(TKA)
Primary Purpose
Arthritis, Knee Arthropathy, Robotics
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Robotic-assisted TKA
Conventional TKA
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Robot
Conventional
Arm Description
TKA is done with robotic-assisted manner. Final implantation of implants is done by surgeons, same as the conventional way. Robotic-assisted TKA for this arm.
TKA is done with conventional instruments. Conventional TKA for this arm.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03659318
Brief Title
Robotic-Assisted Versus Conventional Total Knee Arthroplasty(TKA)
Official Title
Is Clinical Outcome of Robotic-Assisted TKA Better Than Conventional Manual TKA?Prospective, Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 2002 (Actual)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ewha Womans University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
Robotic-assisted TKA was introduced in an attempt to enhance component alignment and to improve long-term clinical results and implant durability, particularly in younger patients. Several comparative studies of conventional and robotic-assisted TKAs demonstrated that improved alignment of the components was obtained after the robotic-assisted TKAs than conventional TKAs.
To date, however, no comprehensive synthesis of long-term randomized data has been conducted specifically for robotic-assisted TKA, particularly in younger patients. It is crucial to determine whether improved alignment of the TKA components obtained by using robotic-assistance, would improve better long-term and functional results and survivorship of TKAs.
The aims of the current study were to examine the two groups of patients after long-term follow-up to determine whether the clinical results, radiographic and CT scan results, and the survivorship of TKA would be better after robotic-assisted TKA than after conventional TKA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Knee Arthropathy, Robotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
674 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Robot
Arm Type
Experimental
Arm Description
TKA is done with robotic-assisted manner. Final implantation of implants is done by surgeons, same as the conventional way. Robotic-assisted TKA for this arm.
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
TKA is done with conventional instruments. Conventional TKA for this arm.
Intervention Type
Procedure
Intervention Name(s)
Robotic-assisted TKA
Intervention Description
Total knee arthroplasty is carried out with help of robotic surgery system, using a Robodoc system. CT-based preoperative planning using ORTHODOC (Integrated Surgical Technology Corp) performed in the first step before the day of surgery, and the robotic-assisted surgery using the ROBODOC surgical assistance in the second step. The bone markers are registered to the computer, and the computer arm does all the cutting and preparation of bones. This is in contrast to conventional jigs and cutting blocks. Actual implantation of the implants is done by a surgeon. A Duracon posterior cruciate-substituting total knee prosthesis (Stryker Orthopedics, Mahawh, NJ, USA) are used in all knees.
Intervention Type
Procedure
Intervention Name(s)
Conventional TKA
Intervention Description
Total knee arthroplasty is carried out with classical, conventional, manual method. A surgeon measures the angle, length of the cuts with bone landmarks and specialized surgical instruments. After all the cuts actual implantation is done. A Duracon posterior cruciate-substituting total knee prosthesis (Stryker Orthopedics, Mahawh, NJ, USA) are used in all knees.
Primary Outcome Measure Information:
Title
Knee society Knee score
Description
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
Time Frame
20 years after the surgery
Secondary Outcome Measure Information:
Title
WOMAC score
Description
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.
Time Frame
20 years after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
7673281
Citation
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. doi: 10.2106/00004623-199509000-00006.
Results Reference
background
PubMed Identifier
3068365
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.
Results Reference
background
PubMed Identifier
17563698
Citation
Bellemans J, Vandenneucker H, Vanlauwe J. Robot-assisted total knee arthroplasty. Clin Orthop Relat Res. 2007 Nov;464:111-6. doi: 10.1097/BLO.0b013e318126c0c0.
Results Reference
background
PubMed Identifier
16213997
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. doi: 10.1016/j.arth.2005.05.020.
Results Reference
background
PubMed Identifier
15513489
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. doi: 10.1080/00016470410001448.
Results Reference
background
PubMed Identifier
27325369
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.
Results Reference
background
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Robotic-Assisted Versus Conventional Total Knee Arthroplasty(TKA)
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