Clinical trial NCT03146819: A Single Time-Point Study to Evaluate the ConforMIS iTotal (PS) Knee Replacement System Versus Off-the-Shelf
Official title: A Single Time-Point Study to Evaluate the ConforMIS iTotal® (PS) Knee Replacement System Versus Off-the-Shelf Knee Replacement Systems
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoarthritis, Knee
Keywords: osteoarthritis
osteoarthritis knee
total knee replacement
patient specific
total knee arthroplasty
orthopedics
Lead sponsor: Restor3D
Sponsor class: INDUSTRY
First posted: 2017-05-10
Enrollment: 31
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: This study is designed to compare outcome data for patients who have recently undergone surgery with the iTotal® Posterior Stabilizing (PS) Knee Replacement System (hereafter referred to as the "iTotal") versus those who have undergone surgery with Off-the-Shelf (OTS) systems.

Detailed description: This is a prospective, single-time point study that will be conducted in the US.To compare outcomes of these two study groups, this study will include routine office questionnaires such as the Knee Society Score (KSS) and the Knee Injury and Osteoarthritis Outcome Score (KOOS).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 with which the subjects are familiar.

Eligibility criteria: Inclusion Criteria:

* Implant must be a minimum of 6 months post-op and doing well in the opinion of site staff
* Subject has had a knee replacement utilizing a fixed bearing PS (Posterior Stabilized) implant design
* \> 18 years of age
* Willingness to participate in the clinical study, to give informed consent, and to perform all evaluations

Exclusion Criteria:

* Simultaneous or staged bilateral procedure
* 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 testing differences
timeFrame: At least 6 months post-surgery
Secondary outcomes:
measure: Knee Society Clinical Rating Score
timeFrame: At least 6 months post-surgery
measure: The Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: At least 6 months post-surgery
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Bethesda Orthopedic
state: Maryland
Study officials:
affiliation: Bethesda Orthopedic
name: Christopher Cannova, MD
role: PRINCIPAL_INVESTIGATOR
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