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The aim of the present double blind controlled study is to evaluate the effects in terms of pain control and functional recovery provided by a single intra-operative injection of ACP performed at the end of arthroscopic partial meniscectomy.
Patients included in this trial will be randomized in two treatment groups: the first one will receive a single injection of 3-5 cc of ACP (using a dedicated centrifuge) at the end of the arthroscopic meniscectomy, whereas the second group will be treated by surgery alone. In order to ensure the double blinding of the trial all the patients enrolled will undergo blood harvesting before anesthesia, and acp will be produced just for the patients included in ACP group.
All patients will be evaluated basally, and then at 15, 30, 60, and 180 days after surgery by the following evaluation tools: IKDC (International Knee Documentation Committee) subjective, VAS (Visual Analogue Score) for pain, EQ-VAS for general Health Status, KOOS (Knee Injury and Osteoarthritis Outcome Score) and Tegner score. Furthermore, during the basal evaluation and at each follow-up visit up to 2 months, active and passive Range of Motion (ROM) of both the operated and contralateral knee were documented; also in addition, the trans-patellar circumference of both knees was registered to assess the trend of knee swelling over time.
Drugs assumption during the follow-up period will be recorded for each patient. All eventual adverse events occurred during the follow-up period will be registered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACP GROUP | Experimental | Patients will receive a single intra-op ACP injection following a procedure of arthroscopic partial meniscectomy (medial or lateral) |
|
| CONTROL GROUP | Other | Patients will be treated by standard meniscectomy alone (medial or lateral) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACP | Biological | Autologous Conditioned Plasma will be obtained directly in the operatory room from the peripheral venous blood of the patient, and injected intra-articularly at the end of arthroscopic meniscectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Change in IKDC (International Knee Documentation Committee) score over the various follow-up times | basal, 15,30,60,180 days | |
| Change in VAS( Visual Analogue score) for pain over the various follow-up times | basal, 15,30,60,180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in KOOS (Knee Injury and Osteoarthritis Outcome Score) over the various follow-up times | basal, 15,30,60,180 days | |
| Change in Tegner Score over the various follow-up times | basal, 30,60,180 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alessandro Di Martino, MD | Nano-biotechnology Lab, Rizzoli Orthopaedic Institute, Bologna, Italy | Study Director |
| Giuseppe Filardo, MD | Biomechanics Lab, Rizzoli Orthopaedic Institute, Bologna, Italy | Principal Investigator |
| Berardo Di Matteo, MD | Biomechanics Lab, Rizzoli Orthopaedic Institute, Bologna, Italy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rizzoli Orthopaedic Institute | Bologna | 40136 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23863849 | Background | Abrams GD, Frank RM, Gupta AK, Harris JD, McCormick FM, Cole BJ. Trends in meniscus repair and meniscectomy in the United States, 2005-2011. Am J Sports Med. 2013 Oct;41(10):2333-9. doi: 10.1177/0363546513495641. Epub 2013 Jul 17. | |
| 25952818 | Background | Filardo G, Di Matteo B, Di Martino A, Merli ML, Cenacchi A, Fornasari P, Marcacci M, Kon E. Platelet-Rich Plasma Intra-articular Knee Injections Show No Superiority Versus Viscosupplementation: A Randomized Controlled Trial. Am J Sports Med. 2015 Jul;43(7):1575-82. doi: 10.1177/0363546515582027. Epub 2015 May 7. |
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| Standard Meniscectomy | Other | Patients will receive standard arthroscopic meniscectomy |
|
| Change in transpatellar circumference over time | basal, 15,30,60,180 days |
| Change in active and passive ROM | basal, 15,30,60,180 days |
| Adverse events report | 15 days after surgery |
| Adverse events report | 30 days after surgery |
| Adverse events report | 60 days after surgery |
| Adverse events report | 180 days after surgery |
| Change in VAS for general health status | basal, 30,60,180 days |
| 26135713 | Background | Heard BJ, Barton KI, Chung M, Achari Y, Shrive NG, Frank CB, Hart DA. Single intra-articular dexamethasone injection immediately post-surgery in a rabbit model mitigates early inflammatory responses and post-traumatic osteoarthritis-like alterations. J Orthop Res. 2015 Dec;33(12):1826-34. doi: 10.1002/jor.22972. Epub 2015 Jul 7. |
| 20954664 | Background | Thein R, Haviv B, Kidron A, Bronak S. Intra-articular injection of hyaluronic acid following arthroscopic partial meniscectomy of the knee. Orthopedics. 2010 Oct 11;33(10):724. doi: 10.3928/01477447-20100826-11. |
| 24275957 | Background | Filardo G, Kon E, Roffi A, Di Matteo B, Merli ML, Marcacci M. Platelet-rich plasma: why intra-articular? A systematic review of preclinical studies and clinical evidence on PRP for joint degeneration. Knee Surg Sports Traumatol Arthrosc. 2015 Sep;23(9):2459-74. doi: 10.1007/s00167-013-2743-1. Epub 2013 Nov 26. |
| 24080861 | Background | Andia I, Maffulli N. Platelet-rich plasma for managing pain and inflammation in osteoarthritis. Nat Rev Rheumatol. 2013 Dec;9(12):721-30. doi: 10.1038/nrrheum.2013.141. Epub 2013 Oct 1. |
| 22284405 | Background | Boswell SG, Cole BJ, Sundman EA, Karas V, Fortier LA. Platelet-rich plasma: a milieu of bioactive factors. Arthroscopy. 2012 Mar;28(3):429-39. doi: 10.1016/j.arthro.2011.10.018. Epub 2012 Jan 28. |
| 26784189 | Background | Lee HR, Shon OJ, Park SI, Kim HJ, Kim S, Ahn MW, Do SH. Platelet-Rich Plasma Increases the Levels of Catabolic Molecules and Cellular Dedifferentiation in the Meniscus of a Rabbit Model. Int J Mol Sci. 2016 Jan 16;17(1):120. doi: 10.3390/ijms17010120. |
| 26605189 | Background | Blanke F, Vavken P, Haenle M, von Wehren L, Pagenstert G, Majewski M. Percutaneous injections of Platelet rich plasma for treatment of intrasubstance meniscal lesions. Muscles Ligaments Tendons J. 2015 Oct 20;5(3):162-6. doi: 10.11138/mltj/2015.5.3.162. eCollection 2015 Jul-Sep. |
| 25377191 | Background | Pujol N, Salle De Chou E, Boisrenoult P, Beaufils P. Platelet-rich plasma for open meniscal repair in young patients: any benefit? Knee Surg Sports Traumatol Arthrosc. 2015 Jan;23(1):51-8. doi: 10.1007/s00167-014-3417-3. Epub 2014 Nov 7. |
| 25663423 | Background | Griffin JW, Hadeed MM, Werner BC, Diduch DR, Carson EW, Miller MD. Platelet-rich plasma in meniscal repair: does augmentation improve surgical outcomes? Clin Orthop Relat Res. 2015 May;473(5):1665-72. doi: 10.1007/s11999-015-4170-8. Epub 2015 Feb 6. |
| 39425245 | Derived | Lo Presti M, Costa GG, Agro G, Vasco C, Boffa A, Di Martino A, Andriolo L, Cenacchi A, Zaffagnini S, Filardo G. Platelet-Rich Plasma Injections Do Not Improve the Recovery After Arthroscopic Partial Meniscectomy: A Double-Blind Randomized Controlled Trial. Am J Sports Med. 2024 Nov;52(13):3198-3205. doi: 10.1177/03635465241283052. Epub 2024 Oct 18. |