Patellofemoral Osteoarthritis
Conditions
Keywords
PRP, HA, Osteoarthritis, Autologous PRP, PRP injection, HA injection, injection treatment, Randomized controlled trial, Hyaluronic Acid, Platelet rich plasma
Brief summary
The aim of the study is to compare the 12-month clinical outcomes of patients with patellofemoral osteoarthritis undergoing infiltrative treatment with fresh PRP and HA
Detailed description
166 patients affected by patellofemoral osteoarthritis will be included in a double-blinded RCT. In this study one group of patients will be treated with 1 intra-articular injection of PRP (treatment arm) and one group will be treated with 1 intra-articular injection of HA (control arm). Patients will be followed-up with clinical evaluation at baseline and at 2.6.12 and 24 months. Questionnaires will be administered for clinical evaluations during the follow-up visits.
Interventions
PROCEDUREAutologous PRP injection
Patients will be treated with a single injection of Autologous PRP (5 ml) in the knee joint affected by patellofemoral osteoarthritis
PROCEDUREHA injection
Patients will be treated with a single injections of Hyaluronic Acid (5 ml) in the knee joint affected by patellofemoral osteoarthritis
Sponsors
Istituto Ortopedico Rizzoli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
This is a double-blinded 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 in which one group of patients will be treated with 1 intra-articular injection of fresh PRP, and one group will be treated with 1 intra-articular injection of HA.
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 30 and 65; 2. Signs and symptoms of isolated patellofemoral osteoarthritis present in one or both knees; 3. Radiographic signs of isolated patellofemoral osteoarthritis (according to Iwano et al stage 1-3 classification) or chondropathy (assessed on MRI) with K-L grade of the other compartments ≤ 2. \[PMID: 2302884 - PMID: 27979409\] ; 4. Hemoglobin \> 11 g/dl; Platelet count \> 150,000 plt/mm3 (Recently performed CBC exam); 5. No clinically significant electrocardiographic alterations (Recently performed ECG). 6. Ability and consent of patients to actively participate in clinical follow-up; 7. Signature of informed consent.
Exclusion criteria
1. Patients unable to express consent; 2. Patients who have undergone intra-articular infiltration of another substance within the previous 6 months; 3. Patients undergoing knee surgery within the previous 12 months; 4. Patients with malignant neoplasms; 5. Patients with rheumatic diseases; 6. Patients with diabetes; 7. Patients with hematologic diseases (coagulopathies); 8. Patients on anticoagulant-antiaggregant therapy; 9. Patients with thyroid metabolic disorders; 10. Patients abusing alcoholic beverages, drugs or medications; 11. Body Mass Index \> 35; 12. Patients who have taken NSAIDs in the 3 days prior to blood draw; 13. Patients with cardiovascular disease for which a 60 mL blood draw would be contraindicated; 14. Patients with a recently performed blood test with Hb\< 11 g/dl and Platelets \< 150,000 plt/mm3. 15. Previous treatment of patellar dislocation 16. Iwano score of grade 4.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| KOOS-Pain Score | 12 months | 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 |
|---|---|---|
| KOOS-Pain Score | baseline, 2 month, 6 months , 24 months follow-up | 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. |
| Visual Analogue Scale (VAS) | baseline, 2 month, 6 months, 12 months , 24 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, 2 month, 6 months, 12 months , 24 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, 2 month, 6 months, 12 months , 24 months follow-up | EQ-5D is useful to evaluate the quality life of the patients |
| IKDC-Subjective Score | baseline, 2 month, 6 months, 12 months , 24 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. |
| Objective parameters- Range of Motion | baseline, 2 month, 6 months, 12 months , 24 months follow-up | Evaluation of the Range of Motion for comparative analysis. |
| Objective parameters - Circumferences | baseline, 2 month, 6 months, 12 months , 24 months follow-up | Bilateral trans- and supra- patellar circumferences measurement for comparative analysis |
| Patient Acceptable Symptom State (PASS) | baseline, 2 month, 6 months, 12 months , 24 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. |
| The Kujala Anterior Knee Pain Scale (AKPS) | baseline, 2 month, 6 months, 12 months , 24 months follow-up | It's a 100-point scale consisting of 13 items with a score ranging from 5 to 10 points per item. A score of 0 points indicates the most severe limitation, while a score of 100 points indicates a normal situation. |
| Tegner Activity Level Scale | baseline, 2 month, 6 months, 12 months , 24 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