NCT00665964

Brief Summary

Methodology: This study will be a randomized, multi-center evaluation comparing N2vac polyethylene inserts and patellas with X3 inserts and patellas when used in the Triathlon PS total knee system. Study Duration: 12-18 month enrollment period + 10 year follow-up for each case years total duration Multi-centre study Objectives Primary: To compare the 10 year implant survival of the Triathlon PS total knee system when X3 polyethylene components are used to the same knee system when N2Vac components are used. Secondary: To compare pain, function, radiographic outcomes, and health related quality of life of subjects in both treatment groups. Safety will be assessed by comparison of adverse events between the groups. Number of Subjects 384 cases (197 each group)

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2008

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

12 years

First QC Date

April 22, 2008

Last Update Submit

January 30, 2019

Conditions

OsteoarthritisOA

Keywords

osteoarthritiskneetotal knee arthroplastygonarthrrsispolyethyleneposterior stabilized

Outcome Measures

Primary Outcomes (1)

  • survival rate of polyethylene

    10 years

Secondary Outcomes (5)

  • pain

    10 years

  • function

    10 years

  • radiographic outcomes

    10 years

  • health related quality of life

    10 years

  • adverse events

    10 years

Study Arms (2)

X-3

EXPERIMENTAL

X-3 polyethylene which is a new highly cross-linked poly that is theorized to be more durable in vivo

Device: X-3 polyethylene

N2Vac polethylene

ACTIVE COMPARATOR

conventional polyethylene

Device: N2Vac polethylene

Interventions

X-3 polyethyleneDEVICE

highly cross-linked polyethylene for knee arthroplasty

X-3
N2Vac polethyleneDEVICE

conventional polyethylene

N2Vac polethylene

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The subject requires a primary cemented total knee replacement.
  • The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
  • The subject has intact collateral ligaments.
  • The subject has signed the ethic committee approved, study specific Informed Patient Consent Form.
  • The subject is willing and able to comply with post-operative scheduled clinical and radiographic evaluations and rehabilitation.

You may not qualify if:

  • The subject has inflammatory arthritis.
  • The subject is morbidly obese, BMI \> 40.
  • The subject has a history of total or unicompartmental reconstruction of the affected joint.
  • The subject has had a high tibial osteotomy or femoral osteotomy.
  • The subject has a neuromuscular or neurosensory deficiency, that would limit the ability to assess the performance of the device.
  • The subject has a systemic or metabolic disorder leading to progressive bone deterioration.
  • The subject is immunologically suppressed, or receiving chronic steroids (\>30 days duration).
  • The subject's bone stock is compromised by disease or infection and cannot provide adequate support and/or fixation to the prosthesis.
  • The subject has had a knee fusion at the affected joint.
  • The subject has an active or suspected latent infection in or about the knee joint.
  • The subject is a prisoner.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Michael J. Dunbar

    Dalhousie University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 22, 2008

First Posted

April 24, 2008

Study Start

May 1, 2008

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

January 31, 2019

Record last verified: 2019-01

Locations

CA(1)