NCT02535741

Clinical Outcome Study for the Triathlon Cruciate Retaining (CR) Total Knee

Clinical Outcome Study for the Triathlon CR Total Knee

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Stryker Orthopaedics · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

An open label, post-market, non-randomised, historical controlled, multi-centre study of the outcomes of the Triathlon Cruciate Retaining (CR) Total Knee System.

Detailed description

An open label, post-market, non-randomised, historical controlled, multi-centre study of the outcomes of the Triathlon Cruciate Retaining (CR) Total Knee System. The primary objective of this study will be to compare the active range of motion values for the Triathlon CR Total Knee System with those of the Scorpio CR Total Knee System, a historical control group. ROM values will be measured by use of a Goniometer according to the protocol. It is expected that the Triathlon CR Total Knee System group's range of motion is not 5 degrees worse or superior to the control group's range of motion at two-years.

Conditions

• Total Knee Arthroplasty

Interventions

Type	Name	Description
DEVICE	Triathlon CR Total Knee System	Primary total knee replacement

Timeline

• Start date: 2006-10-01
• Primary completion: 2013-05-01
• Completion: 2016-05-01
• First posted: 2015-08-31
• Last updated: 2024-02-22
• Results posted: 2015-12-07

Locations

6 sites across 4 countries: Denmark, Finland, Germany, Spain