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Status unknownNCT02373761Updated Feb 27, 2015

A Prospective Radiostereometric Analysis (RSA) and Clinical Evaluation of the Triathlon Tritanium Total Knee Replacement

An observational study in Osteoarthritis of the Knee, sponsored by Scott Sporer. Status unknown at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-02-27.

Sponsored by Scott Sporer · Observational

The sponsor has not verified this record recently (last verified Feb 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
27
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the detailed description

Primary Hypothesis:

The investigators expect the tibial and patellar components of the Stryker Triathlon Tritanium knee to achieve adequate fixation to the underlying bone.

Secondary Hypotheses:

The investigators expect that there will be no continuous migration between one and two years post-operative in the Triathlon Tritanium components.

The investigators expect to see a correlation between radiolucent lines and migration characteristics using RSA.

The investigators expect that inducible displacement exams taken at 2 years post-operative will be able to distinguish between patients identified by RSA measurements as having inadequate fixation.

The investigators expect to see a significant difference in health status and functional outcomes before and after total knee replacement using the Triathlon Tritanium knee.

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Conditions studied

  • Osteoarthritis of the Knee
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In context

Osteoarthritis, Knee

3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.

This study's planned enrollment of 27 is below the median of 100 across 472 observational studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

This is the only study on the registry with Scott Sporer as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • Lateral or medial collateral ligament instability (> 10° varus/valgus)
  • Leg length discrepancy greater than 10 mm
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
27 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Interventions

  • DeviceStryker Triathlon Tritanium primary knee
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What researchers measure

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.

    Time frame: 3 years

Secondary outcomes

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

    Time frame: 3 years

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Study locations

1 site
  • Central DuPage Hospital
    Winfield, Illinois 60190, United States
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References and documents

Publications

  • 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. PubMed 7744919 ↗
  • 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. PubMed 23140091 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02373761
Lead sponsor
Scott Sporer
Collaborators
Stryker Orthopaedics
Responsible party
Scott Sporer (Medical Director, Orthopedic Institute, Central DuPage Hospital) — Sponsor-investigator
First posted
Feb 27, 2015
Start date
Feb 2015
Primary completion
Feb 2019 (estimated)
Last update
Feb 27, 2015

Study contacts

Scott Sporer, MD
Contact
scottsporer@gmail.com
630-933-6254
Stefanie Miller, BS
Contact
stefanie.miller@cadencehealth.org
630-933-6254
Scott Sporer, MD
principal investigator · Central DuPage Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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