Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| MicroPort Orthopedics Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate performance of two modern total knee arthroplasty designs using patient reported outcomes and force exhibited during various activities of daily living.
48 patients with primary osteoarthritis of the knee who have been appropriately designated for treatment with a total knee arthroplasty (TKA) will be randomly assigned to one of two groups; one group (24 patients) will receive a Depuy Attune PCR knee implant, and one group (24 patients) will receive a MicroPort Orthopedics Evolution Medial Pivot knee implant utilizing standard and modern techniques. These two implants are designed to recreate the kinematic motion of a native knee articulation using different biomechanical design philosophies.
The patients will be monitored post-operatively using subjective and objective measures. Subjective patient reported outcomes will be analyzed using the Knee Injury and Osteoarthritis Outcome Score (KOOS), recorded preoperatively, as well as at 6 weeks, and 3 months postoperatively. Objective outcomes will be measured by having the patients perform four activities over force plates that will measure the amount of force a patient generates. The four activities will be: walking, standing from a seated position in a chair, squatting to a seated position, and walking up stairs. These objective measures will also be recorded preoperatively, 6 weeks, and 3 months postoperatively. The patient reported outcomes and the objective measures will then be compared between the two groups.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Depuy Attune | Active Comparator | Subjects will have been implanted with the Depuy Attune PCR TKA |
|
| MicroPort Medial Pivot | Active Comparator | Subjects will have been implanted with the Microport Evolution Medial Pivot TKA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MicroPort Orthopedics EVOLUTION Medial Pivot TKA | Device | Subjects will have been implanted with the Microport Evolution Medial Pivot TKA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score | KOOS Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms | pre-operatively |
| Knee Injury and Osteoarthritis Outcome Score | KOOS Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms | 6 weeks post-operatively |
| Knee Injury and Osteoarthritis Outcome Score | KOOS Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms | 3 months post-operatively |
| Force generated by operative extremity - walking | Distribution of maximum force between implanted and non- implanted leg during walking | pre-operatively |
| Force generated by operative extremity - walking | Distribution of maximum force between implanted and non- implanted leg during walking | 6 weeks post-operatively |
| Force generated by operative extremity - walking | Distribution of maximum force between implanted and non- implanted leg during walking | 3 months post-operatively |
| Force generated by operative extremity - standing from seated position | Distribution of maximum force between implanted and non- implanted leg during standing from a seated position in a chair |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Russell Nevins, MD | Contact | 702-731-1616 | russellnevinsmd@gmail.com | |
| Kevin Sagers | Contact | 702-538-6929 | kevsagers11@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Russell Nevins | Desert Orthopedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Desert Orthopaedic Center | Recruiting | Las Vegas | Nevada | 89121 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D007718 | Knee Injuries |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
The patient will be randomized to one of 2 treatment arms using a random number generator. The care provider will not be blinded as he will be implanting the device and following the patients' progress in clinic postoperatively, including radiographs which will show the implants. He will be blinded, however, to the results of the KOOS score and the data derived from the force plate analysis. The research assistants performing those assessments will be blinded to which treatment arm the patient belongs to.
| Depuy Synthes ATTUNE PCR TKA | Device | Subjects will have been implanted with the Depuy Attune PCR TKA |
|
| pre-operatively |
| Force generated by operative extremity - standing from seated position | Distribution of maximum force between implanted and non- implanted leg during standing from a seated position in a chair | 6 weeks post-operatively |
| Force generated by operative extremity - standing from seated position | Distribution of maximum force between implanted and non- implanted leg during standing from a seated position in a chair | 3 months post-operatively |
| Force generated by operative extremity - squatting to a seated position | Distribution of maximum force between implanted and non- implanted leg during squatting to a seated position | pre-operatively |
| Force generated by operative extremity - squatting to a seated position | Distribution of maximum force between implanted and non- implanted leg during squatting to a seated position | 6 weeks post-operatively |
| Force generated by operative extremity - squatting to a seated position | Distribution of maximum force between implanted and non- implanted leg during squatting to a seated position | 3 months post-operatively |
| Force generated by operative extremity - walking up stairs | Distribution of maximum force between implanted and non- implanted leg during walking up stairs | pre-operatively |
| Force generated by operative extremity - walking up stairs | Distribution of maximum force between implanted and non- implanted leg during walking up stairs | 6 weeks post-operatively |
| Force generated by operative extremity - walking up stairs | Distribution of maximum force between implanted and non- implanted leg during walking up stairs | 3 months post-operatively |
| D012216 |
| Rheumatic Diseases |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |