Comparison Between Robotic-arm Assisted Total Knee Replacement and Traditional Total Knee Replacement

May 24, 2022 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Comparison Between Robotic-Arm Assisted Modified Kinematic Alignment Total Knee Replacement And Traditional Manual Alignment Total Knee Replacement：A Prospective Multicenter, Double-Blind Study

This is a multicenter, prospective, and case-control study. Five joint centers and 100 participants will be included. The study group used robotic-assisted modified kinematic alignment total knee replacement, and the control study used traditional alignment manual total knee replacement. The knee society score (KSS), Hip-knee-ankle(HKA) angle, mechanical lateral distal femoral angle(mLDFA), mechanical medial proximal tibial angle(mMPTA), sagittal femoral component angle(SFCA), range of motion(ROM), WOMAC score, SF-36, Visual Analogue Scale(VAS score), surgical time, blood loss, and complications are evaluated and compared.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age between 18 years and 85 years
  • primary total knee replacement

Exclusion Criteria:

  • obvious bone defect
  • infection
  • BMI>>35kg/m2
  • severe osteoporosis
  • mental disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: robotic-arm assisted modified kinematic alignment total knee replacement
The patients in this group receive robotic-arm assisted total knee replacement. And these patients achieve modified kinematic alignment.
Device: robotic assisted total knee replacement
the study group used robotic-arm assisted total knee replacement.
Active Comparator: traditional manual total knee replacement
The patients in this group receive traditional manual total knee replacement. And these patients achieve traditional alignment.
Device: traditional total knee replacement
the control group used traditional total knee replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KSS score
Time Frame: 3 months
Keen Society Score
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HKA angle
Time Frame: 3 months
hip-knee-ankle angle
3 months
mLDFA
Time Frame: 3 months
mechanical lateral distal femoral angle
3 months
mMPTA
Time Frame: 3 months
mechanical medial proximal tibial angle
3 months
SFCA
Time Frame: 3 months
sagittal femoral component angle
3 months
knee ROM
Time Frame: 3 months
knee range of motion
3 months
blood loss
Time Frame: intraoperative
the intraoperative blood loss
intraoperative
surgical duration
Time Frame: intraoperative
the duration of the operation
intraoperative
complication
Time Frame: 3 months
complications after the surgery
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

May 1, 2025

Study Completion (Anticipated)

October 1, 2025

Study Registration Dates

First Submitted

May 22, 2022

First Submitted That Met QC Criteria

May 24, 2022

First Posted (Actual)

May 25, 2022

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 24, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202203

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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