Ignite Creation Date:
2025-12-24 @ 12:11 PM
Ignite Modification Date:
2026-02-20 @ 10:57 PM
Study NCT ID:
NCT02924961
Status:
TERMINATED
Last Update Posted:
2018-03-07
First Post:
2016-09-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluoroscopic and RSA Evaluation of the Triathlon Total Knee Prosthetic Design
Sponsor:
Leiden University Medical Center
Organization:
Study Overview
Official Title:
Fluoroscopic and RSA Evaluation of the Triathlon Total Knee Prosthetic Design
Status:
TERMINATED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Mobile-bearing insert dislocation
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to compare the fixed bearing (FB) Triathlon knee (Stryker, USA) and the mobile bearing (MB) Triathlon knee (Stryker, USA) and study the effect of implant design on kinematics and micromotion. During two tasks the kinematics measured with fluoroscopy (kinematics and movement of the polyethylene bearing). Roentgen Stereophotogrammetric Analysis (RSA) will be used to evaluate micromotion between prosthesis and the bone for the MB and FB Triathlon knee.
Detailed Description:
The goal of this study is to perform a kinematic evaluation of a MB and FB knee prosthesis designs (Triathlon, Stryker, USA), by means of fluoroscopy and RSA and compare the different designs. The findings of this study will contribute to improve total knee designs and improve rehabilitation strategies.
Objectives:
1. To evaluate if there is micromotion of the prosthesis with respect to the bone and if there is a different migration pattern between the designs.
2. To assess and compare the in vivo kinematic patterns of the knee designs by means of fluoroscopy. This will be done on a subset of the patients (the first 20 patients able to perform step-up and lunge motions 6 months post-operatively in a controlled manner without the use of bars and walk more than 1 km)
3. To evaluate if the polyethylene bearing in the mobile bearing is rotating and if this changes over time.
4. Results of the RSA study will be used to correlate the kinematic parameters (fluoroscopy) with the migration results in order to identify factors of risk for the survival of total knee prostheses.
Objectives:
1. To evaluate if there is micromotion of the prosthesis with respect to the bone and if there is a different migration pattern between the designs.
2. To assess and compare the in vivo kinematic patterns of the knee designs by means of fluoroscopy. This will be done on a subset of the patients (the first 20 patients able to perform step-up and lunge motions 6 months post-operatively in a controlled manner without the use of bars and walk more than 1 km)
3. To evaluate if the polyethylene bearing in the mobile bearing is rotating and if this changes over time.
4. Results of the RSA study will be used to correlate the kinematic parameters (fluoroscopy) with the migration results in order to identify factors of risk for the survival of total knee prostheses.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: