Knee Disease
Conditions
Brief summary
Randomized controlled single blind trial for the evaluation of the treatment of the surgical wound healing process with Platelet-Rich-Fibrin compared to the gold standard (without Platelet-Rich-Fibrin) in patients undergoing knee replacement.
Interventions
PROCEDUREtotal knee replacement surgery
total knee replacement surgery
Sponsors
Istituto Ortopedico Rizzoli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Males or females undergoing a total knee prosthesis. * Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions. * Hb \> 11 g/dl; Platelet value \> 150.000 plt/mmc; * Patients with non clinical alteration of ECG; * Signature of informed consent;
Exclusion criteria
* Patients incapable of understanding and of wanting; * Systemic disorders such as diabetes, rheumatic diseases; * Patients with malignancy; * Thyroid metabolic disorders ; * Abuse of alcohol, drugs and pharmaceutical drugs * Body mass index \> 40;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical improvement of the healing process | 2 weeks | Clinical improvement of the healing process, assessed by application of the Hollander Wound Evaluation Scales at 2 weeks of follow up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dermatology life quality | 3 days, 15 days and 1 month | Dermatology life quality index improvement at 3 days, 15 days and 1 month |
Countries
Italy
Outcome results
None listed