TriathlonPA-11 - A retrospective review of Safety and Efficacy of Stryker Triathlon cementless components with Peri-Apatite in Total Knee Replacement

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12611001071910

Acronym

TriathlonPA-11

Enrollment

106

Registered

2011-10-14

Start date

2012-02-20

Completion date

2013-03-27

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Yes

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.

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

Outcome results