A Prospective Radiostereometric Analysis (RSA) and Clinic... | NCT02373761

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

NCT02373761

Sponsor

Scott Sporer

Status

Unknown status

Last Update Posted

Feb 27, 2015Estimated

Enrollment

27Estimated

Phase

Not provided

Conditions

Osteoarthritis of the Knee

Interventions

Stryker Triathlon Tritanium primary knee

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Feb 2019Estimated

Completion Date

Not provided

First Submitted Date

Feb 13, 2015

First Submission Date that Met QC Criteria

Feb 26, 2015

First Posted Date

Feb 27, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2015

Last Update Posted Date

Feb 27, 2015Estimated

Name	Class
Stryker Orthopaedics	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

27Estimated

Name	Type	Description	Arm Group Labels	Other Names
Stryker Triathlon Tritanium primary knee	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Improved health status and functional outcomes as measured by the Knee Society Scoring System and EQ-5D questionnaires.		3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Scott Sporer, MD	Contact	630-933-6254		scottsporer@gmail.com
Stefanie Miller, BS	Contact	630-933-6254		stefanie.miller@cadencehealth.org

Overall Officials

Name	Affiliation	Role
Scott Sporer, MD	Central DuPage Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Central DuPage Hospital		Winfield	Illinois	60190	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
7744919	Result	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.
23140091	Result	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.

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases