Status:
COMPLETED
A Single Time-Point Study to Evaluate the ConforMIS iTotal® (CR) Knee Versus Off-the-Shelf
Lead Sponsor:
Restor3D
Conditions:
Osteoarthritis
Eligibility:
All Genders
18+ years
Brief 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-surg...
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 dail...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
873 Patients enrolled
Trial Details
Trial ID
NCT02251522
Start Date
October 1 2014
End Date
December 1 2016
Last Update
October 25 2023
Active Locations (16)
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1
Denver-Vail Orthopedics
Parker, Colorado, United States, 80134
2
Institute for Orthopaedic Surgery & Sports Medicine
Fort Myers, Florida, United States, 33919
3
Baptist Health South Florida
Miami, Florida, United States, 33176
4
Coastal Orthopaedic & Sports Medicine Ctr
Port Saint Lucie, Florida, United States, 34996