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Not yet recruitingNCT05391152Updated May 25, 2022

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

An interventional study of robotic assisted total knee replacement and traditional total knee replacement in Osteoarthritis, Knee, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Not yet recruiting. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-05-25.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Osteoarthritis, Knee

Keywords

  • robotic-arm assisted
  • total knee replacement
  • kinematic alignment
03

In context

Osteoarthritis, Knee

3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.

This study's planned enrollment of 100 is above the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • obvious bone defect
  • infection
  • BMI>>35kg/m2
  • severe osteoporosis
  • mental disease
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Devicerobotic assisted total knee replacement

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

  • Devicetraditional total knee replacement

    the control group used traditional total knee replacement

06

What researchers measure

Primary outcomes

  1. KSS score

    Keen Society Score

    Time frame: 3 months

Secondary outcomes

  1. HKA angle

    hip-knee-ankle angle

    Time frame: 3 months

  2. mLDFA

    mechanical lateral distal femoral angle

    Time frame: 3 months

  3. mMPTA

    mechanical medial proximal tibial angle

    Time frame: 3 months

  4. SFCA

    sagittal femoral component angle

    Time frame: 3 months

  5. knee ROM

    knee range of motion

    Time frame: 3 months

  6. blood loss

    the intraoperative blood loss

    Time frame: intraoperative

  7. surgical duration

    the duration of the operation

    Time frame: intraoperative

  8. complication

    complications after the surgery

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05391152
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
May 25, 2022
Start date
Sep 1, 2022 (estimated)
Primary completion
May 1, 2025 (estimated)
Completion
Oct 1, 2025 (estimated)
Last update
May 25, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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