Robotic-Assisted Versus Conventional Total Knee Arthroplasty(TKA)

Phase 4

Completed

• Conditions: Arthritis; Knee Arthropathy; Robotics
• Interventions: Procedure: Robotic-assisted TKA; Procedure: Conventional TKA

• Registration Number: NCT03659318
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2002-01
• Primary Completion: 2008-02
• Study Completion: 2018-07
• Study First Submitted: 2018-08-19
• Study First Submitted QC: 2018-09-04
• Study First Posted: 2018-09-06
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-21
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 674

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robot	Robotic-assisted TKA	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.
Conventional	Conventional TKA	TKA is done with conventional instruments. Conventional TKA for this arm.

Primary Outcome Measures

Name	Time	Method
Knee society Knee score	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

Name	Time	Method
WOMAC score	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.