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| Name | Class |
|---|---|
| Zimmer Biomet | INDUSTRY |
| CHU de Québec | UNKNOWN |
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Arthritic disease in people less than 60 years old is increasingly common. Younger, active individuals often present now to orthopaedic surgeons requiring treatment of knee osteoarthritis. Knee arthroplasty has been offered as a viable option to provide pain relief and improve function in the middle-aged patient.
In a previous study submitted for publication, the investigators have looked at BMD in vivo after total knee replacement comparing two different tibial base plate designs in cemented and uncemented implants in terms of stiffness and modularity, and its effect on bone density changes, synovitis, osteolysis or survivorship. The investigators found a difference of 18% in bone mineral density favoring trabecular metal implant over cemented modular metal-back implant in patient between 55 and 75 years of age. The trabecular metal implant thus behaved as it was expected and preserved bone density in an elderly population.
No randomized clinical trial has looked at cemented titanium tibial insert to uncemented trabecular metal tibia insert in young population. In order to isolate stiffness as study variable, one would aim at randomizing a homogeneous patient population undergoing total knee arthroplasty with implants of similar articular geometry designs with different tibial baseplate, titanium versus trabecular metal. The trabecular metal implant is closer to human bone modulus of elasticity.
THE GOAL OF OUR STUDY IS TO
Two groups will be created:
Group 1: NexGen cemented modular metal-backed tibial implant (Titanium) Group 2: NexGen uncemented Trabecular Metal(TM) modular tibial implant A total of 88 patients will be recruited
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 45-54 y.o / cemented modular metal-backed tibial implant | Active Comparator | This group will undergo a surgery for a knee arthroplasty following standard procedure at our center |
|
| 55-59 y.o / cemented modular metal-backed tibial implant | Active Comparator | This group will undergo a surgery for a knee arthroplasty following standard procedure at our center |
|
| 45-54 y.o / uncemented Trabecular Metal modular tibial implant | Experimental | This group will undergo a surgery for a knee arthroplasty with a trabecular metal of the tibial implant |
|
| 55-59 y.o / uncemented Trabecular Metal modular tibial implant | Experimental | This group will undergo a surgery for a knee arthroplasty with a trabecular metal of the tibial implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary TKA with cemented modular metal-backed tibial implant | Device | Tibial implant will be done with a cemented implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| DEXA Scan | This exam will quantify the amount of bone density at 24 months after total knee arthroplasty. DXA scan can provide accurate, high-quality measurements of periprosthetic bone mineral density (BMD) with minimal precision error and a low coeficient of variation ranging from 1.3% to 4.7%17. | 24 months post-op |
| KOOS (knee injury and osteoarthritis outcomes score ) | The Index is self-administered and assesses the 5 subscales: pain (9 questions), other symptoms (7 questions), function in daily living (17 questions), function in sports and recreation (5) and knee related quality of live (4). All subscales are on 100, 100 being the best score, 0 the worst. The total score is an average of all subscale | 2 years post-op |
| KSS (Knee Society Score) | The original KSS has a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions. | 2 years post-op |
| Measure | Description | Time Frame |
|---|---|---|
| The 12-item medical outcomes study short form health survey version 2.0 (SF-12v2) | This self-administered generic health status measure is composed of 12 items measuring 3 major health attributes: functional status, well-being, and overall evaluation of health | 2 years post-op |
| Lyshom and Tegner |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michel Malo, ND | Hôpital Sacré-Coeur de Montréal | Principal Investigator |
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| Primary TKA with uncemented trabecular metal | Device | Tibial implant will be done with a uncemented implant |
|
The Lysholm Scale currently consists of eight items that measure: pain (25 points), instability (25 points), locking (15 points), swelling (10 points), limp (5 points), stair climbing (10 points), squatting (5 points), and need for support (5 points). Every question response has been assigned an arbitrary score on an increasing scale. The total score is the sum of each response to the eight questions, and may range from 0-100. Higher scores indicate a better outcome with fewer symptoms or disability. |
| 2 years post-op |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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