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compare changes in BMD via DXA at the level of the femoral and tibial periprosthetic bone between two groups of patients undergoing cemented TKA of different design (posterior stabilization vs posterior cruciate preservation) with proms at a 2-year follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PS TKA | Active Comparator | Patients with Posterior stabilized Total knee replacement |
|
| CR TKA | Active Comparator | Patients with cruciate retaining Total knee replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dual energy x-ray absorptiometry | Diagnostic Test | Patient will undergo periodic (6-12-24m) dexa scans on the periprosthetic bone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Periprosthetic bone mineral density measurement | measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry | at baseline (day 0) |
| Periprosthetic bone mineral density measurement | measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry | 6 months |
| Periprosthetic bone mineral density measurement | measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry | 12 months |
| Periprosthetic bone mineral density measurement | measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry | 24 months |
| 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 |
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Inclusion Criteria:
to. Primary or secondary osteoarthritis b. Collagen disorders and/or avascular necrosis of the femoral condyle c. Moderate valgus, varus or flexion deformities (HKA within ±10°, flexion contracture <10°) 3. Patients consenting and able to complete planned study procedures and follow-up assessments 4. Patients informed about the nature of the study who signed the "informed consent" approved by the ethics committee.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stefano Zaffagnini | Recruiting | Bologna | Italia | Italy |
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| ID | Term |
|---|---|
| D015502 | Absorptiometry, Photon |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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 | 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, Function in Sport and Recreation, and knee-related Quality of Life . 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 , Function in Sport and Recreation , and knee-related Quality of Life . 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 , Function in Sport and Recreation , and knee-related Quality of Life . 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 , Function in Sport and Recreation , and knee-related Quality of Life . 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 |
| Istituto ortoepdico rizzoli | Recruiting | Bologna | 40136 | Italy |
|
| D003720 |
| Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |