Osteoarthritis
Conditions
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.
Interventions
DEVICEConforMIS Total Knee Replacement System
Total knee replacement system using a patient specific implant.
Total knee replacement system not using a patient specific implant.
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany, United States
Outcome results
None listed