NCT02251522

A Single Time-Point Study to Evaluate the ConforMIS iTotal® (CR) Knee Versus Off-the-Shelf

A Single Time-Point Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System Versus Off-the-Shelf Replacement

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 873 (actual)
• Sponsor: Restor3D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

It has been noted that patients "dramatically overestimate their functional ability early after surgery." Despite use of assistive devices increasing and functional testing scores decreasing post-surgery, the patient reported outcome scores fail to show worsening. Outcome questionnaires will be administered and functional testing will be conducted on all patients to capture these changes.

Detailed description

The functional testing used in this study consists of tests that physical therapists use daily as objective methods to assess patients' functional status. The testing is designed to closely mimic daily activities that the patients are familiar with.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	ConforMIS Total Knee Replacement System	Total knee replacement system using a patient specific implant.
DEVICE	Off-the-Shelf Knee Replacement System	Total knee replacement system not using a patient specific implant.

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-10-01
• Completion: 2016-12-01
• First posted: 2014-09-29
• Last updated: 2023-10-25

Locations

16 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated device study