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No continued funding.
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| Name | Class |
|---|---|
| Zimmer Biomet | INDUSTRY |
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A functional outcomes comparison study of three surgical techniques using minimally invasive surgery mini-incision (MIS) for total knee arthroplasty (TKA), standard para-patellar TKA and the unicompartmental knee arthroplasty performed over a 2+ year post-op period.
The purpose of this research study is to compare post-operative knee function of persons who have undergone one of three types of knee arthroplasty for the treatment of knee osteoarthritis. A variety of functional performance tests will be assessed and compared using a group of evaluations including: functional activity performance tests and questionnaires; leg strength; knee range of motion; and forces at the knee during a series of activities (walking, bending, stepping etc.) via a motion analysis system. The study will compare the three surgical subject groups and one group of healthy, non-surgical subjects for a total of 100 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIS knee arthroplasty | Persons scheduled for Minimally Invasive Surgery Mini-Incision (MIS) Total Knee Arthroplasty (TKA) | ||
| Unicompartmental knee arthroplasty | Persons scheduled for Unicompartmental knee arthroplasty | ||
| Standard knee arthroplasty | Persons scheduled for Standard Para-patellar surgery TKA | ||
| Heathly knee subjects | Persons with healthy knees |
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| Measure | Description | Time Frame |
|---|---|---|
| Isokinetic and isometric quadriceps and hamstring strength | Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| American Academy Orthopaedic Surgeons Knee Score | Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years | |
| University California Los Angeles Activity Score | Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years |
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Inclusion Criteria:
TKA subjects:
Healthy subjects:
Exclusion Criteria:
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TKA subjects:
Subjects will be selected and recruited from the MGH Arthroplasty Clinic. The surgical decision for TKA approach will be made prior to recruitment for the study.
Healthy persons:
Healthy subjects will be recruited through orthopedic departmental advertisement flyers and by word of mouth.
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| Name | Affiliation | Role |
|---|---|---|
| Henrik Malchau, PhD, MD | Massachusetts General Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) | Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years |
| Timed "Up & Go" Test | Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years |
| Sit to Stand to Sit (STSTS) Test | Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years |
| Stair Test | Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years |
| Visual Analog Pain Scale | Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years |
| Knee adductor moment during gait and chair rise | Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years |
| Knee loading pattern during gait & chair rise | Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years |
| D012216 |
| Rheumatic Diseases |