NCT02494544

A Multicenter Study to Evaluate Functional Outcome After Knee Replacement

A Prospective, Multicenter Study to Evaluate Functional Outcome After Knee Replacement

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: Restor3D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients will be consecutively enrolled by implant. Implant groups will be those who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system. The patient will conduct functional testing and answer questionnaires. The results will compare the ConforMIS iTotal with an Off the Shelf Knee replacement.

Detailed description

To compare functional and patient reported outcome data for a consecutively enrolled group of subjects who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system.The person conducting the functional testing will be blinded to the device implanted. Sites will perform the off-the-shelf total knees conventional instrumentation.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Off the Shelf Total Knee Replacement	A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
DEVICE	ConforMIS iTotal Knee Replacement	A knee replacement performed with patient specific implant and surgical jigs.

Timeline

• Start date: 2015-07-01
• Primary completion: 2022-11-16
• Completion: 2022-11-16
• First posted: 2015-07-10
• Last updated: 2025-11-21
• Results posted: 2025-10-08

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study