NCT01398800

Brief Summary

Long term follow-up is needed to determine whether current Mobile Bearing revision Total Knee Arthroplasty (TKA) designs will improve implant longevity. The potential advantages of mobile bearings in the revision TKA setting include reduction in polyethylene wear, decreasing fixation stresses, and protection of the constraining mechanisms. Several studies have reported satisfactory clinical results after revision total knee arthroplasty but no study with a large number has specifically addressed the clinical outcomes after revision total knee arthroplasty using the mobile bearing design

Trial Health

87
On Track

Trial Health Score

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

Enrollment
340

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Longer than P75 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

July 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2011

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

October 24, 2019

Status Verified

October 1, 2019

Enrollment Period

8.1 years

First QC Date

July 19, 2011

Last Update Submit

October 22, 2019

Conditions

Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

  • Function and knee score of the knee society scoring at every 2 years until 10 years.

    Follow up data of 1,2,4,6,8,and 10 years to evaluate bearing complications and clinical results for the use of MB in revision TKA. Retrospective clinical and radiographic evaluation of 197 mobile bearing revision TKA's will be collected. We will also analyze patient demographics and reason for revisions as well as implants used in revision.

    1-10 years post operative of revision

Secondary Outcomes (1)

  • Radiographic analysis by our orthopedic clinician to determine component failure or loosening.

    Post op - 1-10 years or revision surgery

Eligibility Criteria

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

All patients of Colorado Joint Replacement

You may qualify if:

  • Requiring a revision of a primary knee replacement. Indications for revision include instability, aseptic loosening, failed unicompartmental knee replacement, infection reimplantation, arthrofibroisis, chronic hemarthrosis, failed patellofemoral replacments, and non union of a supracondylar femur fracture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Colorado Joint Replacement

Denver, Colorado, 80210, United States

Location

Study Officials

  • Raymond Kim, MD

    Colorado Joint Replacement

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Raymond Kim

Study Record Dates

First Submitted

July 19, 2011

First Posted

July 21, 2011

Study Start

July 1, 2011

Primary Completion

July 30, 2019

Study Completion

July 30, 2019

Last Updated

October 24, 2019

Record last verified: 2019-10

Locations

US(1)