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the objective of the present study is to compare the post-operative laxity using stress radiographs and clinical scores in two groups of patients undergoing primary PS TKA with identical prosthetic model performed in two specialized centers, of which one group implanted with standard technique and one group through the intraoperative use of the tensioner
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard | Active Comparator |
| |
| Tensor | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tensor | Procedure | balancing will be carried out using the TEMIS DePuy tensioner and carrying out any releases according to the gap-balancing technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| radiographical images | take stress x-rays (150 N) of the knee using TELOS to objectively and reproducibly analyze the lift-off (distance between the prosthetic component femoral and the tibial prosthetic component measured in mm) | at baseline, after 3 months, after 6 months anfer 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hip-Knee-Anke Angle | Hip-Knee-Anke Angle (HKA) on orthostatic panoramic radiographs of the pre- and post-operative lower limbs of the knee. | at baseline, after 3 months, after 6 months anfer 12 months |
| Visual Analogue Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Istituto Ortopedico Rizzoli | Recruiting | Bologna | 40136 | Italy |
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| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D056324 | Diffusion Tensor Imaging |
| ID | Term |
|---|---|
| D059906 | Neuroimaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| standard | Procedure | primary TKA implantation with ligament balancing without use of the tensioner |
|
Visual Analogue Scale (VAS) for pain: a scale from 0 to 10 where 0 is no pain and 10 is the worst pain ever
| at baseline, after 3 months, after 6 months anfer 12 months |
| D038524 |
| Diffusion Magnetic Resonance Imaging |
| D008279 | Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003943 | Diagnostic Techniques, Neurological |
| D008919 | Investigative Techniques |