Intra-operative Injection of Autologous Conditioned Plasma (ACP) Following Partial Meniscectomy
NCT ID: NCT02872753
Last Updated: 2023-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
90 participants
INTERVENTIONAL
2017-07-11
2023-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Early Viscosupplementation After Partial Meniscectomy: a Randomized Controlled Trial
NCT02629380
Degenerative Meniscus Without Osteoarthritis : Arthroscopic Partial Menisectomy Versus Platelet Rich Plasma (APM-PRP)
NCT04972331
Evaluation of Survival and Clinical Outcomes of Patients Treated With Isolated All-inside Meniscal Sutures or With Meniscal Sutures Associated With Ligament Reconstruction
NCT07289412
Study of Clinical Performance and Safety of Treatments in Degenerative Meniscopathy With Injection of Polynucleotides
NCT05322005
Autologous Conditioned Plasma (ACP) Intra-articular (IA) Injections for Knee Osteoarthritis (OA)
NCT02713542
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ACP GROUP
Patients will receive a single intra-op ACP injection following a procedure of arthroscopic partial meniscectomy (medial or lateral)
ACP
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
CONTROL GROUP
Patients will be treated by standard meniscectomy alone (medial or lateral)
Standard Meniscectomy
Patients will receive standard arthroscopic meniscectomy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ACP
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
Standard Meniscectomy
Patients will receive standard arthroscopic meniscectomy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* healthy contra-lateral knee (i.e. no pain or functional limitation in the contra-lateral joint);
Exclusion Criteria
* previous surgery on the index knee;
* other concurrent articular lesion requiring surgical treatment (e.g.: cartilage or ligament injuries);
* history of knee infectious arthritis;
* concurrent rheumatic, metabolic or severe systemic disease;
* Body Mass Index (BMI) \> 30;
* known hypersensibility or allergy to/towards HA ;
* alcohol or other substances abuse/excess.
18 Years
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Istituto Ortopedico Rizzoli
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alessandro Di Martino, MD
Role: STUDY_DIRECTOR
Nano-biotechnology Lab, Rizzoli Orthopaedic Institute, Bologna, Italy
Giuseppe Filardo, MD
Role: PRINCIPAL_INVESTIGATOR
Biomechanics Lab, Rizzoli Orthopaedic Institute, Bologna, Italy
Berardo Di Matteo, MD
Role: STUDY_CHAIR
Biomechanics Lab, Rizzoli Orthopaedic Institute, Bologna, Italy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rizzoli Orthopaedic Institute
Bologna, , Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ACP-MEN
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.