NCT00734084

A Study to Evaluate the DePuy Minimally Invasive Unicompartmental Knee

A Prospective, Non-Comparative Multi-centre Study to Evaluate the Safety and Performance of the DePuy Minimally Invasive (Preservation) Unicompartmental Knee and Instrumentation.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 247 (actual)
• Sponsor: DePuy International · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this investigation is to evaluate the surgical performance of the DePuy Minimally Invasive (Preservation) Unicompartmental Knee and Instrumentation in a Multi-centre setting. The secondary objective of this investigation is to evaluate the long-term survivorship of the DePuy Minimally Invasive (Preservation) Unicompartmental Knee.

Detailed description

Primary endpoint - to demonstrate the suitability of the developed instrumentation to safely and accurately implant the preservation Unicompartmental Knee using postoperative radiographic limb and component alignment data. Secondary endpoints - to demonstrate the survivorship and performance of the Preservation Unicompartmental Knee using the American Knee Society clinical and radiological assessment, Oxford Knee Score and survivorship analysis.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Preservation Unicompartmental Knee	Minimally invasive orthopaedic implant for single compartment knee arthritis

Timeline

• Start date: 2001-06-01
• Primary completion: 2004-12-01
• Completion: 2008-04-01
• First posted: 2008-08-13
• Last updated: 2015-06-09

Locations

1 site across 1 country: Australia