NCT02373761

Brief Summary

This study seeks to find out if the tibial and patellar components of the Stryker Triathlon Tritanium primary total knee replacement achieve adequate fixation to the underlying bone.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Last Updated

February 27, 2015

Status Verified

February 1, 2015

Enrollment Period

4 years

First QC Date

February 13, 2015

Last Update Submit

February 26, 2015

Conditions

Osteoarthritis of the Knee

Outcome Measures

Primary Outcomes (1)

  • Radiostereometric analysis of tibial and patellar components of the Stryker Triathlon Tritanium at 6 weeks, 3 months, 6 months, 1 year and 2 years.

    3 years

Secondary Outcomes (1)

  • Improved health status and functional outcomes as measured by the Knee Society Scoring System and EQ-5D questionnaires.

    3 years

Interventions

Stryker Triathlon Tritanium primary kneeDEVICE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community sample of patients undergoing total knee replacement with the Triathlon Tritanium knee components at Central DuPage Hospital.

You may qualify if:

  • Symptomatic osteoarthritis of the knee indicating surgical intervention
  • Scheduled to undergo a total knee arthroplasty
  • Patients between the ages of 18 and 80, inclusive
  • Patient is a candidate for Triathlon Tritanium cementless knee components implanted in accordance with product labeling

You may not qualify if:

  • Significant co-morbidity affecting ability to ambulate
  • Prior arthroplasty, patellectomy or osteotomy with the affected knee
  • Active or prior infection of the affected knee
  • Morbid obesity (BMI \> 40)
  • Medical condition precluding major surgery
  • Severe osteoporosis
  • Neuromuscular impairment
  • Pregnancy
  • Inability to give informed consent
  • Inability to return for follow-up visits for a minimum of two years after surgery
  • Currently participating in any other surgical intervention study
  • Known allergy to metals
  • Flexion contracture greater than 15°
  • Extension lag greater than 10°
  • Tibial subluxation greater than 10 mm on standing AP radiograph
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central DuPage Hospital

Winfield, Illinois, 60190, United States

Location

Related Publications (2)

  • Ryd L, Albrektsson BE, Carlsson L, Dansgard F, Herberts P, Lindstrand A, Regner L, Toksvig-Larsen S. Roentgen stereophotogrammetric analysis as a predictor of mechanical loosening of knee prostheses. J Bone Joint Surg Br. 1995 May;77(3):377-83.

    PMID: 7744919RESULT

  • Pijls BG, Valstar ER, Nouta KA, Plevier JW, Fiocco M, Middeldorp S, Nelissen RG. Early migration of tibial components is associated with late revision: a systematic review and meta-analysis of 21,000 knee arthroplasties. Acta Orthop. 2012 Dec;83(6):614-24. doi: 10.3109/17453674.2012.747052. Epub 2012 Nov 9.

    PMID: 23140091RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Scott Sporer, MD

    Central DuPage Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott Sporer, MD

CONTACT

630-933-6254scottsporer@gmail.com

Stefanie Miller, BS

CONTACT

630-933-6254stefanie.miller@cadencehealth.org

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Director, Orthopedic Institute

Study Record Dates

First Submitted

February 13, 2015

First Posted

February 27, 2015

Study Start

February 1, 2015

Primary Completion

February 1, 2019

Last Updated

February 27, 2015

Record last verified: 2015-02

Locations

US(1)