NCT01367925

Brief Summary

This study compares the clinical and radiographic outcomes obtained with the use of the Stryker Triathalon® Cruciate Substituting (CS) and Posterior Stabilized (PS) tibial inserts.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2007

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

December 1, 2007

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 7, 2011

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

December 13, 2017

Status Verified

December 1, 2017

Enrollment Period

8.6 years

First QC Date

May 22, 2011

Last Update Submit

December 11, 2017

Conditions

Osteoarthritis, Knee

Keywords

OsteoarthritisTotal Knee ReplacementTKAKneePSCS

Outcome Measures

Primary Outcomes (1)

  • Clinical outcomes, Knee Society Score

    Clinical outcomes to include overall success, failure rate, revison rate, clinical scores (Knee Society Score), range of motion, pain, stability, radiographic success

    Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative

Study Arms (2)

Cruciate Substituting Tibial Insert

Device: Stryker Triathlon® CS Tibial Insert

Posterior Stabilized Tibial Insert

Device: Stryker Triathlon® PS Tibial Insert

Interventions

Stryker Triathlon® CS Tibial InsertDEVICE
Cruciate Substituting Tibial Insert
Stryker Triathlon® PS Tibial InsertDEVICE
Posterior Stabilized Tibial Insert

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients undergoing total knee arthroplasty

You may qualify if:

  • Adults ages 20-80 years old
  • Body mass index \<40
  • Undergoing primary total knee arthroplasty for osteoarthritis of the knee

You may not qualify if:

  • Inflammatory arthritis
  • Revisions
  • Other criteria may apply

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spokane Joint Replacement Center

Spokane, Washington, 99218, United States

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • David F Scott, MD

    Spokane Joint Replacement Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

May 22, 2011

First Posted

June 7, 2011

Study Start

December 1, 2007

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

December 13, 2017

Record last verified: 2017-12

Locations

US(1)