NCT05391152

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

May 25, 2022

Status Verified

March 1, 2022

Enrollment Period

2.7 years

First QC Date

May 22, 2022

Last Update Submit

May 24, 2022

Conditions

Osteoarthritis, Knee

Keywords

robotic-arm assistedtotal knee replacementkinematic alignment

Outcome Measures

Primary Outcomes (1)

  • KSS score

    Keen Society Score

    3 months

Secondary Outcomes (8)

  • HKA angle

    3 months

  • mLDFA

    3 months

  • mMPTA

    3 months

  • SFCA

    3 months

  • knee ROM

    3 months

  • +3 more secondary outcomes

Study Arms (2)

robotic-arm assisted modified kinematic alignment total knee replacement

EXPERIMENTAL

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

traditional manual total knee replacement

ACTIVE COMPARATOR

The patients in this group receive traditional manual total knee replacement. And these patients achieve traditional alignment.

Device: traditional total knee replacement

Interventions

robotic assisted total knee replacementDEVICE

the study group used robotic-arm assisted total knee replacement.

robotic-arm assisted modified kinematic alignment total knee replacement
traditional total knee replacementDEVICE

the control group used traditional total knee replacement

traditional manual total knee replacement

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2022

First Posted

May 25, 2022

Study Start

September 1, 2022

Primary Completion

May 1, 2025

Study Completion

October 1, 2025

Last Updated

May 25, 2022

Record last verified: 2022-03