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

Status:	Enrolling by invitation
Conditions:	Arthritis, Osteoarthritis (OA)
Therapuetic Areas:	Rheumatology
Healthy:	No
Age Range:	18 - Any
Updated:	5/14/2016
Start Date:	October 2014
End Date:	December 2016

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

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.

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.

Inclusion Criteria:

- Implant must be at least 6 months post-op and doing well

- Patient has had a total CR knee implant

- > 18 years of age

Exclusion Criteria:

- Simultaneous bilateral procedure occurred

- BMI > 40

- Other physical disability that requires an aid for walking or disability affecting
the hips, spine, contralateral knee or other joint that limits function

- Participation in another clinical study which would confound results

- Inability to complete the protocol in the opinion of the clinical staff due to safety
or other reasons

We found this trial at

sites

Vitos Orthopädische Klinik Kassel

Kassel,

from

Kassel,