NCT03668756

Brief Summary

To compare the functional outcomes of Computer-Assisted Navigation (CAS) and Conventional Instrumentation TKA at the 8-year follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
Last Updated

September 13, 2018

Status Verified

September 1, 2018

Enrollment Period

10 months

First QC Date

September 11, 2018

Last Update Submit

September 12, 2018

Conditions

Arthropathy of Knee Joint

Outcome Measures

Primary Outcomes (1)

  • International Knee Society (IKS)

    To assess the functional outcome of TKA by self-explanatory questionnaire

    up to 8-year follow-up

Secondary Outcomes (4)

  • Radiographic evaluation

    Baseline and 3 months after operation

  • Hospital for Special Surgery (HSS) Questionnaire

    Baseline, 8-year follow-up

  • Western Ontario and McMaster University Osteoarthritis Index (WOMAC)

    Baseline, 8-year follow-up

  • Short Form-36 (SF-36) Health Survey

    Baseline, 8-year follow-up

Study Arms (2)

Computer-Assisted Navigation TKA

the patients who were received CAS TKA in one limb

Procedure: Computer-Assisted Navigation TKA

Conventional TKA

the patients who were received conventional TKA in one limb

Interventions

Computer-Assisted Navigation TKAPROCEDURE

TKAs were performed using the image-free CAS navigation system VectorVision

Computer-Assisted Navigation TKA

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients who were scheduled to undergo staged bilateral TKA and randomly assigned to receive CAS TKA in one limb and conventional TKA in the other at the 8-year follow-up.

You may qualify if:

  • The patients who were scheduled to undergo staged bilateral TKA and randomly assigned to receive CAS TKA in one limb and conventional TKA in the other at the 8-year follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sports Medicine Center, Chang Gung Memorial Hospital

Pizi, 613, Taiwan

Location

Study Officials

  • Robert Wen-Wei HSU, MD

    Sports Medicine Center, Chang Gung Memorial Hospital, Chiayi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2018

First Posted

September 13, 2018

Study Start

November 1, 2017

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

September 13, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)