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evaluate the clinical outcome of the implantation of a specific primary TKA model implanted with the aid of inertial sensors for the execution of bone cuts through the administration of questionnaires for the calculation of clinical-functional scores;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient treated with PS Link Symphoknee prosthesis and Orthokey perseus alignment device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Knee arthroplasty | Device | Knee arthroplasty surgery with perseus orthokey alignment device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Knee Society Score | Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100 | at baseline (day 0) |
| Knee Society Score | Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100 | 6 months |
| Knee Society Score | Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100 | 12 months |
| Knee Society Score | Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100 | 24 months |
| Western Ontario and McMaster Universities Arthritis Index | The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96 | at baseline (day 0) |
| Western Ontario and McMaster Universities Arthritis Index | The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96 | 6 months |
| Western Ontario and McMaster Universities Arthritis Index | The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96 |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic evaluation of prosthetic femoral component positioning | measurement of prosthetic femoral component alignment according to femoral mechanical axis | 5 days after index surgery |
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Inclusion Criteria:
Male and female subjects 50 years of age or older and less than 85 years of age (>50 and <85 years) who are candidates for primary cemented total knee replacement based on physical examination and medical history, including diagnosis of severe knee pain and disability due to at least one of the following causes:
Patients consent and able to complete scheduled study procedures and follow-up assessments.
Patients informed about the nature of the study who signed the "informed consent" approved by the ethics committee.
Exclusion Criteria:
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Patients candidates to TKA surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefano Zaffagnini, Prof | Contact | 0516366075 | stefano.zaffagnini@unibo.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stefano Zaffagnini | Recruiting | Bologna | Italia | Italy |
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| ID | Term |
|---|---|
| D011475 | Prosthesis Failure |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| 12 months |
| Western Ontario and McMaster Universities Arthritis Index | The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96 | 24 months |
| Knee injury and Osteoarthritis Outcome Score | The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). the score goes from 0 to 100 | at baseline (day 0) |
| Knee injury and Osteoarthritis Outcome Score | The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). the score goes from 0 to 100 | 6 months |
| Knee injury and Osteoarthritis Outcome Score | The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). the score goes from 0 to 100 | 12 months |
| Knee injury and Osteoarthritis Outcome Score | The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). the score goes from 0 to 100 | 24 months |
| 36-Item Short Form Health Survey | is a valid and reliable tool for measuring health outcomes in patients with musculoskeletal pain, but its sensitivity to clinical changes in patients with specific disorders may be limited, rated on a scale of 0 to 100, with 0 and 100 being minimum and maximum possible scores. | at baseline (day 0) |
| 36-Item Short Form Health Survey | is a valid and reliable tool for measuring health outcomes in patients with musculoskeletal pain, but its sensitivity to clinical changes in patients with specific disorders may be limited, rated on a scale of 0 to 100, with 0 and 100 being minimum and maximum possible scores. | 6 months |
| 36-Item Short Form Health Survey | is a valid and reliable tool for measuring health outcomes in patients with musculoskeletal pain, but its sensitivity to clinical changes in patients with specific disorders may be limited, rated on a scale of 0 to 100, with 0 and 100 being minimum and maximum possible scores. | 12 months |
| 36-Item Short Form Health Survey | is a valid and reliable tool for measuring health outcomes in patients with musculoskeletal pain, but its sensitivity to clinical changes in patients with specific disorders may be limited, rated on a scale of 0 to 100, with 0 and 100 being minimum and maximum possible scores. | 24 months |
| Forgotten joint score | a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint | at baseline (day 0) |
| Forgotten joint score | a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint | 6 months |
| Forgotten joint score | a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint | 12 months |
| Forgotten joint score | a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint | 24 months |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |