NCT01751334

Brief Summary

The anatomic landmark for the anteroposterior (AP) axis of the proximal tibia and its variability was investigated in this study in order to determine whether a certain landmark could be employed as a reference axis for the proximal tibia after rotating platform mobile bearing (RP-MB) and fixed bearing (FB) total knee arthroplasties (TKAs).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_4

Status
completed

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

Study Start

First participant enrolled

September 1, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 18, 2012

Completed
Last Updated

December 18, 2012

Status Verified

December 1, 2012

Enrollment Period

11 months

First QC Date

December 13, 2012

Last Update Submit

December 13, 2012

Conditions

Osteoarthritis

Keywords

ArthroplastyReplacementKneeRotational Alignment

Outcome Measures

Primary Outcomes (1)

  • Tibial anteroposterior axis relative to femoral anteroposterior axis

    Tibial anteroposterior axis relative to femoral anteroposterior axis on Computed tomogram images

    postoperative 2 weeks

Study Arms (2)

Mobile Bearing

EXPERIMENTAL

Mobile bearing total knee arthroplasty

Device: total knee arthroplasty

Fixed Bearing

ACTIVE COMPARATOR

Fixed Bearing total knee arthroplasty

Device: total knee arthroplasty

Interventions

total knee arthroplastyDEVICE

Mobile Bearing Total knee Arthroplasty

Also known as: Sigma® RP-F Knee System, Depuy J&J, Warsaw, IN, USA
Mobile Bearing

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Primary osteoarthritis

You may not qualify if:

  • infection
  • inflammatory arthritis
  • reoperation
  • severe deformity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Sahnghoon Lee, M.D., Ph.D.

    PRINCIPAL INVESTIGATOR

  • Myung Chul Lee, M.D., Ph.D.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2012

First Posted

December 18, 2012

Study Start

September 1, 2005

Primary Completion

August 1, 2006

Study Completion

August 1, 2011

Last Updated

December 18, 2012

Record last verified: 2012-12