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Robotic-Assisted Versus Conventional Total Knee Arthroplasty(TKA)

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ClinicalTrials.gov Identifier: NCT03659318
Recruitment Status : Completed
First Posted : September 6, 2018
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Young Hoo Kim, Ewha Womans University

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.

Condition or disease Intervention/treatment Phase
Arthritis Knee Arthropathy Robotics Procedure: Robotic-assisted TKA Procedure: Conventional TKA Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 674 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Is Clinical Outcome of Robotic-Assisted TKA Better Than Conventional Manual TKA?Prospective, Randomized Study
Actual Study Start Date : January 2002
Actual Primary Completion Date : February 2008
Actual Study Completion Date : July 2018

Arm Intervention/treatment
Experimental: Robot
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.
Procedure: Robotic-assisted TKA
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.

Active Comparator: Conventional
TKA is done with conventional instruments. Conventional TKA for this arm.
Procedure: Conventional TKA
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 Measures :
  1. Knee society Knee score [ Time Frame: 20 years after the surgery ]
    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 :
  1. WOMAC score [ Time Frame: 20 years after the surgery ]
    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.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Publications:
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Responsible Party: Young Hoo Kim, Professor, Ewha Womans University
ClinicalTrials.gov Identifier: NCT03659318    
Other Study ID Numbers: RoboTKA
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases