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Osteoarthritis, KneeNCT05391152

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

A study testing robotic assisted total knee replacement and traditional total knee replacement in people with Osteoarthritis, Knee, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
robotic assisted total knee replacement and traditional total knee replacement
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
1 Sep 2022to 1 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: 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.

Being tested
robotic assisted total knee replacement, traditional total knee replacement
Keywords
robotic-arm assisted, total knee replacement, kinematic alignment
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • robotic assisted total knee replacementDevice

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

  • traditional total knee replacementDevice

    the control group used traditional total knee replacement

Study groups in NCT05391152
Study groupRoleWhat they receive
robotic-arm assisted modified kinematic alignment total knee replacementExperimentalThe patients in this group receive robotic-arm assisted total knee replacement. And these patients achieve modified kinematic alignment.
Receives: Device: robotic assisted total knee replacement
traditional manual total knee replacementActive comparatorThe patients in this group receive traditional manual total knee replacement. And these patients achieve traditional alignment.
Receives: Device: traditional total knee replacement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. KSS score

    Keen Society Score

    Measured: 3 months

Secondary outcomes (8)

  1. HKA angle

    hip-knee-ankle angle

    Measured: 3 months

  2. mLDFA

    mechanical lateral distal femoral angle

    Measured: 3 months

  3. mMPTA

    mechanical medial proximal tibial angle

    Measured: 3 months

  4. SFCA

    sagittal femoral component angle

    Measured: 3 months

  5. knee ROM

    knee range of motion

    Measured: 3 months

  6. blood loss

    the intraoperative blood loss

    Measured: intraoperative

  7. surgical duration

    the duration of the operation

    Measured: intraoperative

  8. complication

    complications after the surgery

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2022
  2. Study start1 Sep 2022 (estimated)
  3. Primary completion1 May 2025 (estimated)
  4. Study completion1 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05391152
Sponsor's protocol ID
202203
Status last verified
Mar 2022
First submitted
22 May 2022
Last updated
25 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing robotic assisted total knee replacement and traditional total knee replacement in people with Osteoarthritis, Knee, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

KSS score (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05391152.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022; AzTrials last refreshed its copy on 31 Oct 2026.

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