Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001071910
Ethics application status
Approved
Date submitted
14/10/2011
Date registered
14/10/2011
Date last updated
11/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
TriathlonPA-11 - A retrospective review of Safety and Efficacy of Stryker Triathlon cementless components with Peri-Apatite in Total Knee Replacement
Scientific title
TriathlonPA-11 - A retrospective review of Safety and Efficacy of Stryker Triathlon cementless components with Peri-Apatite in Total Knee Replacement
Secondary ID [1] 273170 0
Nil
Universal Trial Number (UTN)
U1111-1125-0753
Trial acronym
TriathlonPA-11
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stryker Triathlon cementless Total Knee Replacement with Peri-Apatite 278919 0
Condition category
Condition code
Surgery 279100 279100 0 0
Surgical techniques

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study recruits patients that have previously had a Stryker Triathlon cementless Knee Replacement with Peri-Apatite (this was a standard knee replacement procedure with a cementless device).

Patients will be asked to attend a single clinic visit (less than 1 hour duration) at a minimum 2 years post surgery. They will be asked to undertake one x-ray, and answer two questionaires that assess the pain levels, range of motion, stability, and function of the knee.

The enrolment period for this study is expected to be 3 months or until the required sample size is reached. Radiographic Evaluation will take approximately 3 months to complete, therefore it is anticipated that the entire study will take approximately 6 months to complete.
Intervention code [1] 269502 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279743 0
To determine the safety of Triathlon cementless components at a minimum of 2 years post Total knee replacement, via review of post-operative complication and revision rates.
Timepoint [1] 279743 0
2 years post-operatively
Secondary outcome [1] 294354 0
To determine the efficacy of Triathlon cementless components at a minimum of 2 years post Total knee replacement, via assessment of the function and radiographic outcomes through application of the International Knee Society Score and the International Knee Society Radiographic Evaluation, respectively.
Timepoint [1] 294354 0
2 years post-operatively

Eligibility
Key inclusion criteria
1. The patient received a primary cementless Triathlon Total Knee with Peri-Apatite which was performed by Dr Dermot Collopy and is a minimum of 2 years post-surgery.
2. The patient has signed the study specific, HREC-approved, Informed Consent document.
3. The patient is willing and able to comply with the specified clinical and radiographic evaluations.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Patient has a cognitive impairment, an intellectual disability or a mental illness 2. Patients who received a Triathlon PS Femoral Cementless Component 3. Pregnant Women

Study design
Purpose
Natural history
Duration
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/12/2011
Actual
20/02/2012
Date of last participant enrolment
Anticipated
Actual
27/03/2013
Date of last data collection
Anticipated
Actual
27/03/2013
Sample size
Target
100
Accrual to date
Final
106
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 269986 0
Commercial sector/Industry
Name [1] 269986 0
Stryker Australia Pty Ltd
Country [1] 269986 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Stryker Australia Pty Ltd
Address
8 Herbert Street, St Leonards, NSW 2065
Country
Australia
Secondary sponsor category [1] 268976 0
None
Name [1] 268976 0
Address [1] 268976 0
Country [1] 268976 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271952 0
St John of God Health Care Ethics Committee
Ethics committee address [1] 271952 0
St John of God Health Care Ethics Committee
Level 3, St John of God House
177-179 Cambridge Street
Wembley WA 6008
Ethics committee country [1] 271952 0
Australia
Date submitted for ethics approval [1] 271952 0
31/10/2011
Approval date [1] 271952 0
07/12/2011
Ethics approval number [1] 271952 0

Summary
Brief summary
The aim of this study is to collect retrospective data on a consecutive case series to further support registry data and further elucidate the safety and efficacy of both femoral and tibial cementless components.
Trial website
Trial related presentations / publications
Not applicable- no publications yet written
Public notes

Contacts
Principal investigator
Name 33238 0
Dr Dermot Collopy
Address 33238 0
N/A
Country 33238 0
Australia
Phone 33238 0
N/A
Fax 33238 0
Email 33238 0
N/A
Contact person for public queries
Name 16485 0
Mrs Alissa Connelly
Address 16485 0
Stryker South Pacific
8 Herbert Street, St Leonards
NSW 2065
Country 16485 0
Australia
Phone 16485 0
+61 2 9467 1075
Fax 16485 0
Email 16485 0
[email protected]
Contact person for scientific queries
Name 7413 0
Mrs Alissa Connelly
Address 7413 0
Stryker South Pacific
8 Herbert Street, St Leonards
NSW 2065
Country 7413 0
Australia
Phone 7413 0
+61 2 9467 1075
Fax 7413 0
Email 7413 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.