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

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Status

Completed

Conditions

Osteoarthritis

Treatments

Device: Off-the-Shelf Knee Replacement System

Device: ConforMIS Total Knee Replacement System

Study type

Observational

Funder types

Industry

Identifiers

NCT02251522

14-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

873 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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