NCT01520571

Brief Summary

The investigators asked: (1) Do computer-assisted total knee arthroplasty (TKAs) provide better alignment and clinical function? (2) Do computer-assisted TKAs provide better survivorship of implants and less complication? and (3) Do correction of the mechanical axis of the lower limb to within 3° of neutral is a prognostic marker for late revision surgery due to aseptic loosening?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
520

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2000

Longer than P75 for phase_4

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

January 1, 2000

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2001

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2012

Completed
Last Updated

January 30, 2012

Status Verified

January 1, 2012

Enrollment Period

1.9 years

First QC Date

January 19, 2012

Last Update Submit

January 25, 2012

Conditions

Osteoarthritis

Keywords

Computer AssistanceTotal Knee Arthroplastyconventional

Outcome Measures

Primary Outcomes (1)

  • Improvement in Knee Society Knee Score

    change in knee score will be compared with initial score, until follow up of 10.5 years

    10.5 years

Secondary Outcomes (1)

  • Improvement in the range of motion

    10.5 years

Study Arms (2)

Non-Computer Assistance TKA

ACTIVE COMPARATOR

Non-Computer Assistance TKA

Procedure: Non-Computer Assistance TKA

Computer Assistance TKA

EXPERIMENTAL

Computer Assistance TKA

Procedure: Computer Assistance TKA

Interventions

Non-Computer Assistance TKAPROCEDURE

Non-Computer Assistance Total Knee Arthroplasty

Also known as: Non-Computer Assistance Total Knee Arthroplasty
Non-Computer Assistance TKA
Computer Assistance TKAPROCEDURE

Computer Assistance Total Knee Arthroplasty

Also known as: Computer Assistance Total Knee Arthroplasty
Computer Assistance TKA

Eligibility Criteria

Age49 Years - 88 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • End stage osteoarthritis of the knee joint who require total knee arthroplasty with bilateral lesions.

You may not qualify if:

  • Inflammatory disease
  • patient with other Lower extremity disease which may affect functional outcome
  • Neurologic disease effecting patients lower extremity
  • Revision surgery
  • Patient not medically cleared for bilateral surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ewha Womans University Mokdong Hosptial

Seoul, 158-710, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Young-Hoo Kim, MD

    Ewha Womans University School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director

Study Record Dates

First Submitted

January 19, 2012

First Posted

January 30, 2012

Study Start

January 1, 2000

Primary Completion

December 1, 2001

Study Completion

December 1, 2011

Last Updated

January 30, 2012

Record last verified: 2012-01

Locations

KR(1)