Osteoarthritis, Knee
Conditions
Keywords
osteoarthritis, osteoarthritis knee, total knee replacement, patient specific, total knee arthroplasty, orthopedics
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.
Interventions
DEVICEiTotal PS Knee Replacement System
Total Knee Replacement systems (Patient Specific)
Total Knee Replacement systems (Off-the-shelf)
Sponsors
Restor3D
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional testing differences | At least 6 months post-surgery | Physical therapy functional testing between the iTotal PS and off-the-shelf PS implants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Clinical Rating Score | At least 6 months post-surgery | Comparison of scores and sub-scores from the following questionnaires between the study arms |
| The Knee Injury and Osteoarthritis Outcome Score (KOOS) | At least 6 months post-surgery | Comparison of scores and sub-scores from the following questionnaires between the study arms |
Countries
United States
Outcome results
None listed