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Completed

NCT Number: NCT03659318

Robotic-Assisted Versus Conventional Total Knee Arthroplasty(TKA)

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.

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Key information

Conditions

Arthritis Joint Diseases Knee Arthropathy Musculoskeletal Diseases Robotics

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robotic-assisted TKA

Procedure

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.

Conventional TKA

Procedure

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ewha Womans University

Other

Registry information

Official study title

Is Clinical Outcome of Robotic-Assisted TKA Better Than Conventional Manual TKA?Prospective, Randomized Study

Important dates

Study start
2002
Primary completion
2008
Study completion
2018
First posted
Sep 6, 2018
Registry last updated
Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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