Clinical trial NCT02251522: A Single Time-Point Study to Evaluate the ConforMIS iTotal® (CR) Knee Versus Off-the-Shelf
Official title: A Single Time-Point Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System Versus Off-the-Shelf Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Lead sponsor: Restor3D
Sponsor class: INDUSTRY
First posted: 2014-09-29
Enrollment: 873
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include a 1:1 ratio of patients enrolled into both the iTotal arm and the off-the-shelf total knee arm.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Outcome time differences between the two groups
timeFrame: at least 6 months post-op
Secondary outcomes:
measure: Outcomes questionnaire- Knee Society Score
timeFrame: At least 6 months post op
measure: Outcomes questionnaire- KOOS
timeFrame: At least 6 months post op
measure: Outcomes questionnaire- Forgotten Joint Score
timeFrame: At least 6 months post op
Other outcomes:
Locations:
city: Parker
country: United States
facility: Denver-Vail Orthopedics
state: Colorado
city: Fort Myers
country: United States
facility: Institute for Orthopaedic Surgery & Sports Medicine
state: Florida
city: Miami
country: United States
facility: Baptist Health South Florida
state: Florida
city: Port Saint Lucie
country: United States
facility: Coastal Orthopaedic & Sports Medicine Ctr
state: Florida
city: Bethesda
country: United States
facility: Bethesda Orthopedic
state: Maryland
city: Woburn
country: United States
facility: Excel Orthopaedic Specialists
state: Massachusetts
city: Battle Creek
country: United States
facility: Great Lakes Bone & Joint Center
state: Michigan
city: West Bloomfield
country: United States
facility: Lederman-Kwartowitz Center for Orthopedics and Sports Medicine
state: Michigan
city: Henderson
country: United States
facility: Orthopaedic Institute of Henderson
state: Nevada
city: Potsdam
country: United States
facility: St. Lawrence Health System
state: New York
city: Spartanburg
country: United States
facility: Orthopedic Specialties of Spartanburg
state: South Carolina
city: Cypress
country: United States
facility: Advanced Orthopedics & Sports Medicine
state: Texas
city: Kassel
country: Germany
facility: Vitos Orthopädische Klinik Kassel
city: Neutraubling
country: Germany
facility: MedArtes
city: Radebeul
country: Germany
facility: Elblandkliniken Stiftung
city: Stuttgart
country: Germany
facility: Sportklinik Stuttgart
Study officials:
affiliation: Orthopaedic Institute of Henderson
name: Robert Tait, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Mary O'Connor, MD
role: STUDY_CHAIR
References: