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| Name | Class |
|---|---|
| Rubin Institute for Advanced Orthopedics | UNKNOWN |
| MicroPort Orthopedics Inc. | INDUSTRY |
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Patients with degenerative joint disease can effectively be treated with a primary total knee replacement to reduce pain and improve function in their daily lives. Theoretically, achievement of normal knee motion using a medial pivot design in total knee replacements can be recreated in comparison to single radius designs, which could lead to an improvement in post-surgical outcomes and satisfaction with the procedure. The aim of this study is to compare two types of implant designs (medial pivot and single radius) in a total knee replacement using clinical outcomes, patient reported outcomes, and overall function assessed by a specialized gait laboratory.
This is a single center, cohort study in 100 adult subjects undergoing primary total knee arthroplasty that will receive one of the two total knee device systems.
Primary total knee replacement is an effective treatment for relieving pain and improving function for patients with degenerative joint disease. Recently, design of knee implants in a total knee replacement have received increased interest, particularly the medial pivot designs. Single-radius implants are designed to minimize instability throughout the functional range of movement. Medial pivot total knee designs theoretically recreate more normal knee motion when compared to single radius designs. Both implant designs are commonly used for total knee replacements. Outcomes of TKA are evaluated by multiple methods including implant/device survivorship, radiographic assessments, clinical examinations, and patient reported outcome measures (PROMS). Laboratory based gait analysis performed at a specialized research facility is not commonly conducted in patients with positive outcomes post-surgery as this is associated with high cost. There is currently not enough research comparing these two designs directly. Research is required to determine which design may provide better clinical outcomes and satisfaction with the procedure.
In addition to your normal standard clinical care, there will be scheduled pre-operative, operative, 6-week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medial-Pivot Knee System | Active Comparator | Total Knee Arthroplasty will be done by implanting the MicroPort Medial Pivot Knee System into subjects. |
|
| Single Radius Design Total Knee System | Active Comparator | Total Knee Arthroplasty will be done by implanting the Stryker Triathlon Tritanium Knee System into subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting) | Device | Medial Pivot Knee System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Knee Mechanics | Knee flexion/extension, varus/valgus, and internal/external rotation will be measured (in degrees) and analyzed using the KneeKG system during incline and decline walking. | Pre-operative; Post-operative - 3 month and 12 month follow-up visit |
| Change in Anterior/Posterior Knee Translation | This parameter will be measured (in mm) and analyzed using the KneeKG system during incline and decline walking. | Pre-operative; Post-operative - 3 month and 12 month follow-up visit |
| Change in Initial Peak Loading Force | This parameter will be measured (in N) and analyzed using the KneeKG system during normal walking. | Pre-operative; Post-operative - 3 month and 12 month follow-up visit |
| Change in Active and Passive Range of Motion | Active and passive range of motion will be measured (in degrees) using a goniometer. | Pre-operative; Post-operative - 3 month and 12 month follow-up visit |
| Change in Quadriceps Lag | Quadriceps lag will be measured (in degrees) in both the sitting and supine positions. | Pre-operative; Post-operative - 3 month and 12 month follow-up visit |
| Change in Timed up and Go Test (TUG) | This parameter will be measured in seconds and requires a patient to rise from a chair walk three meters and return to the chair again as quickly as possible. | Pre-operative; Post-operative - 3 month and 12 month follow-up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survivorship | Radiographic assessment using AP and lateral knee X-rays to analyze implant position, radiolucencies, fracture, and osteolysis. | Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit |
| Post-surgical Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin Gesheff | Contact | 410-601-9467 | mgesheff@lifebridgehealth.org | |
| Nirav Patel | Contact | 410-601-8860 | nirpatel@lifebridgehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| James Nace, MD | LifeBridge Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sinai Hospital of Baltimore | Recruiting | Baltimore | Maryland | 21215 | United States |
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| Stryker Triathlon Tritanium Knee System (Condylar Stabilizing) | Device | Single Radius Design Total Knee System |
|
| Change in Five Times Sit to Stand Test | This parameter will be measured in seconds and will collect the amount of time it takes a patient to transfer from a seated to a standing position and back to sitting five times. | Pre-operative; Post-operative - 3 month and 12 month follow-up visit |
| Change in Single Limb Stance Test for Both Knees | This parameter will be measured in seconds and will collect the amount of time a patient is able to stand unassisted on one leg. | Pre-operative; Post-operative - 3 month and 12 month follow-up visit |
| Change in Timed Ascent and Descent of One Flight of Stairs Test | This parameter will be measured in seconds and will collect the amount of time it takes a patient to ascend and descend one flight of stairs (8-14 steps). | Pre-operative; Post-operative - 3 month and 12 month follow-up visit |
| Change in Quadriceps Muscle Strength | This parameter will be measured (in lbs/in) using a dynamometer for quadricep muscle strength assessment. | Pre-operative; Post-operative - 3 month and 12 month follow-up visit |
All complications related to the procedure will be documented. |
| Operative visit; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit |
| Evidence of Osteolysis | X-rays will be evaluated to look for presence of a radiolucent area, especially > 2mm, around implant or cement with sclerotic border. | Pre-operative; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit |
| Change in Knee Society Score (KSS) Short Form | 25 question items assessing symptoms, patient satisfaction, patient expectation, and their level of functional activity of their knee. Scores range from 0-100 with higher scores representing better outcomes. | Pre-operative; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit |
| Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) | 42 question items assessing a patient's opinion about their health, symptoms, and function of their knee. Scores range from 0-100 with zero representing severe knee problems and 100 indicating no knee problems. | Pre-operative; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit |
| Change in Patient Reported Outcomes Measurement Information System (PROMIS-10) | 10 question items assessing overall physical, mental, and social health of the patient. Each question item is scored separately on 1-5 scale and total scores are combined into 2 groups - Global Physical Health Score and Global Mental Health score. A T-score is calculated with the 2 previous scores against the general population with a higher T-score representing better outcomes. | Pre-operative; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit |
| Change in Forgotten Joint Score FJS | 12 question items evaluating how "aware" a patient is of their operative joint during daily activities. Scores range between 0-100 with higher scores indicating a patient is able to forget the joint on a daily basis or low joint awareness. | Pre-operative; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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