Periprosthetic Osteolysis
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTdual energy x-ray absorptiometry
Patient will undergo periodic (6-12-24m) dexa scans on the periprosthetic bone
Sponsors
Istituto Ortopedico Rizzoli
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged ≥ 45 years 2. Patients 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: 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
1. Patients aged \< 45 years; 2. Patients who have already undergone hip or knee arthroplasty ankle, previous osteotomy, with severe axial deformities or suffering from rheumatoid arthritis, diabetes or neuromuscular diseases. In this way, homogeneity of the investigated cohort will be guaranteed; 3. Pregnant women. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Periprosthetic bone mineral density measurement | at baseline (day 0) | measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Score | at baseline (day 0) | Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100 |
| Western Ontario and McMaster Universities Arthritis Index | at baseline (day 0) | The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96 |
| Knee injury and Osteoarthritis Outcome Score | at baseline, (day 0) | 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 |
| 36-Item Short Form Health Survey | at baseline (day 0) | 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. |
Countries
Italy
Outcome results
None listed