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Randomized Controlled Trial
. 2024 May 1;7(5):e2410134.
doi: 10.1001/jamanetworkopen.2024.10134.

Intra-Articular Platelet-Rich Plasma Injection After Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial

Zipeng Ye  1 , Huiang Chen  1 , Yi Qiao  1 , Chenliang Wu  1 , Eunshinae Cho  1 , Xiulin Wu  1 , Ziyun Li  1 , Jinlong Wu  1 , Simin Lu  1 , Guoming Xie  1 , Shikui Dong  1 , Junjie Xu  1 , Jinzhong Zhao  1
Affiliations
Randomized Controlled Trial

Intra-Articular Platelet-Rich Plasma Injection After Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial

Zipeng Ye et al. JAMA Netw Open. .

Abstract

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.

Trial registration: Chinese Clinical Trial Registry Identifier: ChiCTR2000040262.

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Conflict of interest statement

Conflict of Interest Disclosures: None reported.

Figures

Figure 1.
Figure 1.. Flowchart of Participant Enrollment, Allocation, Follow-Up, and Analysis
PRP indicates platelet-rich plasma. aRestricted knee flexion (<120°) or restricted knee extension (>5°), measured by placing the axis of a goniometer over the lateral femoral epicondyle. bIncluding posterior cruciate ligament injury, posterolateral complex injury, medial patellofemoral ligament injury, and grade 2 or 3 medial collateral ligament injury. cGrade 3 or 4 (cartilage defects extending down >50% of cartilage depth) of the International Cartilage Repair Society grading, evaluated by arthroscopy during surgery.
Figure 2.
Figure 2.. Mean Scores of the 4 Subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS4) at Baseline and During 12-Month Follow-Up by Group
The KOOS4 is calculated as the mean score for the pain, symptoms, sports and recreation, and quality-of-life subscales of the KOOS. Scores range from 0 to 100, with higher scores indicating better knee-related results. The means and 95% CIs are unadjusted. The between-group differences at follow-up visits were adjusted for the baseline KOOS4 using an analysis of covariance model, with positive values indicating higher scores in the platelet-rich plasma (PRP) group and negative values indicating higher scores in the control group (3 months: mean, −0.4 [95% CI, −6.3 to 5.6]; 6 months: mean, 5.5 [95% CI, 0.4-10.6]; 12 months: mean, 2.0 [95% CI, −2.3 to 6.3]).
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