Knee Osteoarthritis
Conditions
Keywords
knee, knee osteoarthritis, PRP, Homologous PRP, PRP injections, injection treatment, Randomized controlled trial, osteoarthritis
Brief summary
The aim of the study is to compare the 6 months clinical outcome of the treatment with a single injection of Homologous PRP versus single injection of placebo (saline solution) in the infiltrative treatment of knee osteoarthritis in over 65 years old patients. The evaluation will be performed through clinical, subjective and objective assessments.
Detailed description
204 patients affected by knee osteoarthritis will be included in a double-blinded RCT with possibility ,after 6 months, to cross-over from control arm ( saline solution ) to the treatment arm (Homologous PRP). Patients will be followed-up with clinical evaluation at 1,3 and 6 months. During the follow-up visits ,will be evaluated the inflammatory status of the knee by thermographic assessment. Patients in the treatment arm (Homologous PRP) will be followed for an additional 6 months (up to 12 months of follow-up). After 6 months, patients in the control arm have the possibility to cross-over into the treatment arm, in which case they will be followed for an additional 12 months.
Interventions
PROCEDUREHomologous PRP injections
Patients will be treated with a single injection of Homologous PRP (5 ml) in the knee joint affected by osteoarthritis.
PROCEDUREPlacebo injection (saline solution)
Patients will be treated with a single injections of saline solution (5 ml) in the knee joint affected by osteoarthritis
Sponsors
Istituto Ortopedico Rizzoli
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
This is a double-blind randomized controlled trial with 1:1 allocation. Patient blinding will be provided during the injection treatment.
Intervention model description
The study is a double-blinded RCT with possibility ,after 6 months, to cross-over from control arm (saline solution ) to the treatment arm (Homologous PRP). After 6 months, patients in the control arm have the possibility to cross-over into the treatment arm, in which case they will be followed for an additional 12 months.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Unilateral involvement; 2. Signs and symptoms of degenerative pathology of the knee cartilage; 3. Radiographic or MRI signs of degenerative pathology of the knee cartilage (Kellgren-Lawrence 1-4 grades); 4. Ability and consent of patients to actively participate in clinical follow-up; 5. Signature of informed consent
Exclusion criteria
1. Patients undergoing knee surgery within the previous 12 months; 2. Patients with malignant neoplasms; 3. Patients with rheumatic diseases; 4. Patients with diabetes; 5. Patients with hematologic diseases (coagulopathies); 6. Patients with metabolic disorders of the thyroid gland; 7. Patients abusing alcoholic beverages, drugs or medications 8. Body Mass Index \> 35
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| KOOS-Pain Score | 6 months FU | KOOS-Pain Score is referred to a subscale of pain composed by 9 items. The score range considerate is 0-100.The score uses a 5-point Likert scale and each question is assigned a score from 0 to 4, where 0 indicates no pain and 4 severe level of pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IKDC-Subjective Score | baseline, 1 month, 3 months, 6 and 12 months follow-up | This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathologies. All questions examines 3 categories: symptoms, sports activity, and knee function. |
| Visual Analogue Scale (VAS) | baseline, 1 month, 3 months, 6 and 12 months follow-up | VAS is a visual analogue scale consisting of a range scale (10 cm length), the ends of which correspond to no pain and the strongest pain imaginable. |
| EQ-VAS | baseline, 1 month, 3 months, 6 and 12 months follow-up | EQ-VAS Is a visual analog scale that has a range of scores from 0 (worst imaginable health condition) to 100 (best imaginable health condition). |
| EQ-5D (EuroQoL) Current Health Assessment | baseline, 1 month, 3 months, 6 and 12 months follow-up | EQ-5D is useful to evaluate the quality life of the patients |
| KOOS Score | baseline, 1 month, 3 months, 6 and 12 months follow-up | KOOS SCORE consists of 5 subscales and covers: pain (9 items), symptoms (7 items, two of which are related to stiffness), functions and activities of daily living (17 items), physical function, sports and leisure activities (5 items) and quality of life in relation to the knee (4 items). Each question is scored from 0 to 4, where 0 indicates no difficulty and 4 severe difficulty. Score range 0-100 for each subscale |
| Objective parameters- Range of Motion | baseline, 1 month, 3 months, 6 and 12 months follow-up | Evaluation of the Range of Motion for comparative analysis. |
| Patient Acceptable Symptom State (PASS) | baseline, 1 month, 3 months, 6 and 12 months follow-up | A tool to assess patient satisfaction in consideration of their current degree of pain, function, and daily activity. Patients can express if their state of health will be satisfying, answering yes or no. |
| Objective parameters - Circumferences | baseline, 1 month, 3 months, 6 and 12 months follow-up | Bilateral trans- and supra- patellar circumferences measurement for comparative analysis |
| Tegner Activity Level Scale | baseline, 1 month, 3 months, 6 and 12 months follow-up | Tegner activity level scale allows to know the level of physical activity carried out by the patients. All patients will indicate the type of sporting activity performed and its frequency. |
Countries
Italy
Contacts
Primary ContactRoberta Licciardi, Msc
Backup ContactAlessandro Di Martino, MD
Outcome results
None listed