NCT00733330

Minimally Invasive Total Knee Replacement - Navigated Versus Non-navigated Study

Computer Assisted Navigation in Minimally Invasive Total Knee Arthroplasty: Comparing the Alignment Achieved Using the DePuy Ci Minimally Invasive (Mi) Versus the DePuy Non Navigated Conventional Total Knee Arthroplasty.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: DePuy International · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this investigation is to compare the precision of long leg alignment achieved by the two types of procedure. The secondary objectives of this investigation are to: Compare the accuracy of long leg alignment achieved by the two types of procedure. Compare the number of optimal implantations achieved by the two types of procedure. Compare the clinical performance of the knee replacement in subjects who have undergone one of the two types of procedure. Compare the functional outcome achieved by subjects who have undergone one of the two types of procedure. Compare the interface radiographic appearance 5 years post-operatively between the two types of procedure. Compare the accuracy and precision of long leg alignment achieved by the two types of procedure 5 years post-operatively, i.e., at final follow-up and also the change in accuracy and precision between the final follow-up and baseline. Compare the Adverse Events experienced by the subjects who have undergone the two types of procedure.

Detailed description

Primary endpoint: to compare the precision of the long leg alignment of the Ci MiTKA vs. the non navigated conventional TKA, specifically 3 months to demonstrate the variability of the mechanical axis. Secondary endpoints: to compare the precision of the long leg alignment of the Ci MiTKA vs. the non navigated conventional TKA specifically to demonstrate the proportion of procedures that fall within a satisfactory alignment window in either group.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Either P.F.C. Sigma or L.C.S. Complete knee replacement using the conventional surgical approach and manual surgical technique	Orthopaedic implants for total knee replacement implanted with a standard approach using standard instrumentation
DEVICE	Either P.F.C. Sigma or L.C.S. Complete knee replacement using minimally invasive surgical approach and computer navigation	Orthopaedic implants for total knee replacement implanted with a minimally invasive approach and computer navigation

Timeline

• Start date: 2005-01-01
• Primary completion: 2008-12-01
• Completion: 2010-12-01
• First posted: 2008-08-13
• Last updated: 2014-08-15
• Results posted: 2014-08-15

Locations

5 sites across 3 countries: United States, Australia, New Zealand