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

Completed

• Conditions: Osteoarthritis

• Registration Number: NCT02251522
• Lead Sponsor: Restor3D

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-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.

Study Timeline

• Study First Submitted: 2014-09-22
• Study First Submitted QC: 2014-09-25
• Study First Posted: 2014-09-29
• Study Start: 2014-10
• Primary Completion: 2016-10
• Study Completion: 2016-12
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 873

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional Outcome time differences between the two groups	at least 6 months post-op	The study primary endpoint is to compare functional testing time between patients implanted with the iTotal implant verses the off-the-shelf implants

Secondary Outcome Measures

Name	Time	Method
Outcomes questionnaire- Knee Society Score	At least 6 months post op	Comparing different patient outcome scores between the two groups
Outcomes questionnaire- KOOS	At least 6 months post op	Comparing different patient outcome scores between the two groups
Outcomes questionnaire- Forgotten Joint Score	At least 6 months post op	Comparing different patient outcome scores between the two groups

Trial Locations

Locations (16)

Denver-Vail Orthopedics; 🇺🇸 Parker, Colorado, United States

Institute for Orthopaedic Surgery & Sports Medicine; 🇺🇸 Fort Myers, Florida, United States

Baptist Health South Florida; 🇺🇸 Miami, Florida, United States

Coastal Orthopaedic & Sports Medicine Ctr; 🇺🇸 Port Saint Lucie, Florida, United States

Bethesda Orthopedic; 🇺🇸 Bethesda, Maryland, United States

Excel Orthopaedic Specialists; 🇺🇸 Woburn, Massachusetts, United States

Great Lakes Bone & Joint Center; 🇺🇸 Battle Creek, Michigan, United States

Lederman-Kwartowitz Center for Orthopedics and Sports Medicine; 🇺🇸 West Bloomfield, Michigan, United States

Orthopaedic Institute of Henderson; 🇺🇸 Henderson, Nevada, United States

St. Lawrence Health System; 🇺🇸 Potsdam, New York, United States

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