Intra-Articular Platelet-Rich Plasma Injection After Anterior Cruciate Ligament ReconstructionA Randomized Clinical Trial

被引:8
作者
Ye, Zipeng [1 ]
Chen, Huiang [1 ]
Qiao, Yi [1 ]
Wu, Chenliang [1 ]
Cho, Eunshinae [1 ]
Wu, Xiulin [1 ]
Li, Ziyun [1 ]
Wu, Jinlong [1 ]
Lu, Simin [1 ]
Xie, Guoming [1 ]
Dong, Shikui [1 ]
Xu, Junjie [1 ,2 ]
Zhao, Jinzhong [1 ,2 ]
机构
[1] Shanghai Jiao Tong Univ, Sch Med, Shanghai Peoples Hosp 6, Dept Sports Med, Shanghai, Peoples R China
[2] Shanghai Sixth Peoples Hosp, Dept Sports Med, 600 Yishan Rd, Shanghai 200233, Peoples R China
基金
中国国家自然科学基金;
关键词
KNEE OSTEOARTHRITIS; GRAFT; REVASCULARIZATION; VASCULARITY; OUTCOMES; INJURY; MODEL; PAIN; KOOS; TIME;
D O I
10.1001/jamanetworkopen.2024.10134
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
IMPORTANCE Platelet-rich plasma (PRP) has been considered a promising treatment for musculoskeletal disorders. The effects of PRP on clinical outcomes of anterior cruciate ligament reconstruction (ACLR) are controversial. OBJECTIVE To compare subjective outcomes and graft maturity in patients undergoing ACLR with and without postoperative intra-articular PRP injection. DESIGN, SETTING, AND PARTICIPANTS This surgeon- and investigator-masked randomized clinical trial included patients treated at a national medical center in China who were aged 16 to 45 years and scheduled to undergo ACLR. Participants were enrolled between March 21, 2021, and August 18, 2022, and followed up for 12 months, with the last participant completing follow-up on August 28, 2023. INTERVENTIONS Participants were randomized 1:1 to the PRP group (n = 60), which received 3 doses of postoperative intra-articular PRP injection at monthly intervals, or to the control group (n = 60), which did not receive postoperative PRP injection. Both groups had the same follow-up schedule. MAIN OUTCOMES AND MEASURES The primary outcome was the mean score for 4 subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS4) (range, 0-100, with higher scores indicating better knee function and fewer symptoms) at 12 months postoperatively. Secondary outcomes were patient-reported outcomes, graft maturity (on magnetic resonance imaging), and physical examinations at 3, 6, and 12 months. RESULTS Among the 120 randomized participants (mean [SD] age, 29.0 [8.0] years; 84 males [70%]), 114 (95%) were available for the primary outcome analysis. The mean KOOS4 scores at 12 months were 78.3 (SD, 12.0; 95% CI, 75.2-81.4) in the PRP group and 76.8 (SD, 11.9; 95% CI, 73.7-79.9) in the control group (adjusted mean between-group difference, 2.0; 95% CI, -2.3 to 6.3; P = .36). Secondary outcomes were not statistically significantly different between the 2 groups except for sports and recreation level and graft maturity at 6 months. Intervention-related adverse events included pain at the injection site and knee swelling after injection. CONCLUSIONS AND RELEVANCE In this randomized clinical trial among patients undergoing ACLR, the addition of postoperative intra-articular PRP injection did not result in superior improvement of knee symptoms and function at 12 months compared with no postoperative injection. Further studies are required to determine appropriate indications for PRP in musculoskeletal disorders.
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页数:15
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共 62 条
[1]   Rehabilitation versus surgical reconstruction for non-acute anterior cruciate ligament injury (ACL SNNAP): a pragmatic randomised controlled trial [J].
Beard, David J. ;
Davies, Loretta ;
Cook, Jonathan A. ;
Stokes, Jamie ;
Leal, Jose ;
Fletcher, Heidi ;
Abram, Simon ;
Chegwin, Katie ;
Greshon, Akiko ;
Jackson, William ;
Bottomley, Nicholas ;
Dodd, Matt ;
Bourke, Henry ;
Shirkey, Beverly A. ;
Paez, Arsenio ;
Lamb, Sarah E. ;
Barker, Karen ;
Phillips, Michael ;
Brown, Mark ;
Lythe, Vanessa ;
Mirza, Burhan ;
Carr, Andrew ;
Monk, Paul ;
Areia, Carlos Morgado ;
O'Leary, Sean ;
Haddad, Fares ;
Wilson, Chris ;
Price, Andrew .
LANCET, 2022, 400 (10352) :605-615
[2]   Effect of Intra-articular Platelet-Rich Plasma vs Placebo Injection on Pain and Medial Tibial Cartilage Volume in Patients With Knee Osteoarthritis The RESTORE Randomized Clinical Trial [J].
Bennell, Kim L. ;
Paterson, Kade L. ;
Metcalf, Ben R. ;
Duong, Vicky ;
Eyles, Jillian ;
Kasza, Jessica ;
Wang, Yuanyuan ;
Cicuttini, Flavia ;
Buchbinder, Rachelle ;
Forbes, Andrew ;
Harris, Anthony ;
Yu, Shirley P. ;
Connell, David ;
Linklater, James ;
Wang, Bing Hui ;
Oo, Win Min ;
Hunter, David J. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2021, 326 (20) :2021-2030
[3]   Common elective orthopaedic procedures and their clinical effectiveness: umbrella review of level 1 evidence [J].
Blom, Ashley W. ;
Donovan, Richard L. ;
Beswick, Andrew D. ;
Whitehouse, Michael R. ;
Kunutsor, Setor K. .
BMJ-BRITISH MEDICAL JOURNAL, 2021, 374
[4]   The Minimal Clinically Important Difference: A Review of Clinical Significance [J].
Bloom, David A. ;
Kaplan, Daniel J. ;
Mojica, Edward ;
Strauss, Eric J. ;
Gonzalez-Lomas, Guillem ;
Campbell, Kirk A. ;
Alaia, Michael J. ;
Jazrawi, Laith M. .
AMERICAN JOURNAL OF SPORTS MEDICINE, 2023, 51 (02) :520-524
[5]   Effectiveness of Platelet-Rich Plasma in Anterior Cruciate Ligament Reconstruction: A Systematic Review of Randomized Controlled Trials [J].
Cao, Yi ;
Wan, Ye-da .
ORTHOPAEDIC SURGERY, 2022, 14 (10) :2406-2417
[6]   Comparison of Growth Factor and Platelet Concentration From Commercial Platelet-Rich Plasma Separation Systems [J].
Castillo, Tiffany N. ;
Pouliot, Michael A. ;
Kim, Hyeon Joo ;
Dragoo, Jason L. .
AMERICAN JOURNAL OF SPORTS MEDICINE, 2011, 39 (02) :266-271
[7]   Supplementation-time dependence of growth factors in promoting tendon healing [J].
Chan, B. P. ;
Fu, S. C. ;
Qin, L. ;
Rolf, C. ;
Chan, K. M. .
CLINICAL ORTHOPAEDICS AND RELATED RESEARCH, 2006, (448) :240-247
[8]   The "Ligamentization" Process in Anterior Cruciate Ligament Reconstruction What Happens to the Human Graft? A Systematic Review of the Literature [J].
Claes, Steven ;
Verdonk, Peter ;
Forsyth, Ramses ;
Bellemans, Johan .
AMERICAN JOURNAL OF SPORTS MEDICINE, 2011, 39 (11) :2476-2483
[9]   Anterior Cruciate Ligament Reconstruction with Platelet-Rich Plasma: A Systematic Review of Randomized Control Trials [J].
Davey, Martin S. ;
Hurley, Eoghan T. ;
Withers, Dan ;
Moran, Ray ;
Moran, Cathal J. .
ARTHROSCOPY-THE JOURNAL OF ARTHROSCOPIC AND RELATED SURGERY, 2020, 36 (04) :1204-1210
[10]   PRP does not improve the objective outcomes of anterior cruciate ligament reconstruction: a systematic review and meta-analysis [J].
de Andrade, Andre Luis Lugnani ;
Sardeli, Amanda Veiga ;
Garcia, Thiago Alves ;
Livani, Bruno ;
Belangero, William Dias .
KNEE SURGERY SPORTS TRAUMATOLOGY ARTHROSCOPY, 2021, 29 (09) :3049-3058