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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous PRP injection | Experimental | This group of patients will be treated with single intra-articular injection of Autologous PRP. |
|
| HA injection | Active Comparator | This group of patients will be treated with single intra-articular injection of Hyaluronic Acid (HA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous PRP injection | Procedure | Patients will be treated with a single injection of Autologous PRP (5 ml) in the knee joint affected by patellofemoral osteoarthritis |
|
| Measure | Description | Time Frame |
|---|---|---|
| KOOS-Pain Score | 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". | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| IKDC-Subjective Score | 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. | baseline, 2 month, 6 months, 12 months , 24 months follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberta Licciardi, MSc | Contact | 0516366567 | roberta.licciardi@ior.it | |
| Alessandro Di Martino, MD | Contact | alessandro.dimartino@ior.it |
| Name | Affiliation | Role |
|---|---|---|
| Alessandro Di Martino, MD | Istituto Ortopedico Rizzoli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Recruiting | Bologna | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30545242 | Background | Di Martino A, Di Matteo B, Papio T, Tentoni F, Selleri F, Cenacchi A, Kon E, Filardo G. Platelet-Rich Plasma Versus Hyaluronic Acid Injections for the Treatment of Knee Osteoarthritis: Results at 5 Years of a Double-Blind, Randomized Controlled Trial. Am J Sports Med. 2019 Feb;47(2):347-354. doi: 10.1177/0363546518814532. Epub 2018 Dec 13. | |
| 16921694 |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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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.
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This is a double-blinded randomized controlled trial with 1:1 allocation.Patient blinding will be provided during the injection treatment.
| HA injection | Procedure | Patients will be treated with a single injections of Hyaluronic Acid (5 ml) in the knee joint affected by patellofemoral osteoarthritis |
|
| KOOS-Pain Score |
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". |
| baseline, 2 month, 6 months , 24 months follow-up |
| Visual Analogue Scale (VAS) | 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". | baseline, 2 month, 6 months, 12 months , 24 months follow-up |
| EQ-VAS | 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). | baseline, 2 month, 6 months, 12 months , 24 months follow-up |
| EQ-5D (EuroQoL) Current Health Assessment | EQ-5D is useful to evaluate the quality life of the patients | baseline, 2 month, 6 months, 12 months , 24 months follow-up |
| Tegner Activity Level Scale | 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. | baseline, 2 month, 6 months, 12 months , 24 months follow-up |
| Objective parameters- Range of Motion | Evaluation of the Range of Motion for comparative analysis. | baseline, 2 month, 6 months, 12 months , 24 months follow-up |
| Objective parameters - Circumferences | Bilateral trans- and supra- patellar circumferences measurement for comparative analysis | baseline, 2 month, 6 months, 12 months , 24 months follow-up |
| Patient Acceptable Symptom State (PASS) | 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. | baseline, 2 month, 6 months, 12 months , 24 months follow-up |
| The Kujala Anterior Knee Pain Scale (AKPS) | 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. | baseline, 2 month, 6 months, 12 months , 24 months follow-up |
| Everts PA, Knape JT, Weibrich G, Schonberger JP, Hoffmann J, Overdevest EP, Box HA, van Zundert A. Platelet-rich plasma and platelet gel: a review. J Extra Corpor Technol. 2006 Jun;38(2):174-87. |
| 24599205 | Background | Cavallo C, Filardo G, Mariani E, Kon E, Marcacci M, Pereira Ruiz MT, Facchini A, Grigolo B. Comparison of platelet-rich plasma formulations for cartilage healing: an in vitro study. J Bone Joint Surg Am. 2014 Mar 5;96(5):423-9. doi: 10.2106/JBJS.M.00726. |
| 27979409 | Background | deDeugd CM, Pareek A, Krych AJ, Cummings NM, Dahm DL. Outcomes of Patellofemoral Arthroplasty Based on Radiographic Severity. J Arthroplasty. 2017 Apr;32(4):1137-1142. doi: 10.1016/j.arth.2016.11.006. Epub 2016 Nov 15. |
| 24942296 | Background | Assirelli E, Filardo G, Mariani E, Kon E, Roffi A, Vaccaro F, Marcacci M, Facchini A, Pulsatelli L. Effect of two different preparations of platelet-rich plasma on synoviocytes. Knee Surg Sports Traumatol Arthrosc. 2015 Sep;23(9):2690-703. doi: 10.1007/s00167-014-3113-3. Epub 2014 Jun 19. |