NCT04953988

Brief Summary

Developed a robot for minimally invasive TKA surgery and prepare for the subsequent CFDA application of the minimally invasive total knee replacement robot system.

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
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

July 8, 2021

Status Verified

June 1, 2021

Enrollment Period

Same day

First QC Date

June 24, 2021

Last Update Submit

July 1, 2021

Conditions

Osteoarthritis, Knee

Keywords

KOATKArobotic surgery

Outcome Measures

Primary Outcomes (6)

  • Full-length radiography of both lower limbs

    Measurement of lower limb force line and prosthesis position through full-length radiography of both lower limbs

    Before and two days after the operation

  • Conventional anteroposterior radiograph of Both Lower Extremities

    Measurement of lower limb force line and prosthesis position through conventional anteroposterior radiograph of Both Lower Extremities

    Before and two days after the operation

  • computed tomography

    Measurement of lower limb force line and prosthesis position through computed tomography

    Before and two days after the operation

  • Magnetic Resonance Imaging

    Measurement of lower limb force line and prosthesis position through Magnetic Resonance Imaging

    Before and two days after the operation

  • Range of motion

    Knee joint range of motion. Normal flexion 150°, extension 0°

    Before and two days after the operation

  • Operation time

    The time from the start of the skin incision to the completion of the skin suture

    During the operation

Study Arms (2)

Robotic surgery group

EXPERIMENTAL
Procedure: Robotic TKA

Manual operation group

ACTIVE COMPARATOR
Procedure: Manual operation

Interventions

Robotic TKAPROCEDURE

Robotic TKA

Robotic surgery group
Manual operationPROCEDURE

Manual operation

Manual operation group

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No surgery on the knee joint.
  • Age\>55

You may not qualify if:

  • Knee surgery history.
  • Severe knee joint deformity (valgus greater than 15° or valgus greater than 20°) or knee joint instability.
  • Severe flexion contracture deformity.
  • Revision and replacement surgery for knee joints.

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

June 24, 2021

First Posted

July 8, 2021

Study Start

July 1, 2021

Primary Completion

July 1, 2021

Study Completion

August 1, 2023

Last Updated

July 8, 2021

Record last verified: 2021-06