Nanosurgical and Bioengineering Treatment of Human Anterior Cruciate Ligament Tears with Ultrasound-Guided Injection of Modified Platelet-Rich Plasma Using Human Cell Memory Based on Clinical, Ultrasound, MRI, and Nanoscope Analyses: A Double-Blind Randomized Trial

Abstract

Background: Anterior cruciate ligament (ACL) tears account for 40% to 50% of all ligamentous knee injuries. Most patients with ACL ruptures undergo surgical treatment. There is currently no objective, well-documented, repeatable, and standardized nonsurgical method for ACL tear treatment. This study aimed to investigate ACL outcomes in patients who underwent a novel nanosurgery and bioengineering treatment (NSBT) for an ACL tear. Methods: This was a double-blind randomized trial including 44 patients with a history of traumatic knee injury and a confirmed ACL tear. The final sample comprised 40 patients who met all the eligibility criteria. The patients were divided into two groups: the treatment group (n = 30) and the control group (n = 10). The treatment group underwent nanosurgery with an ultrasound-guided injection of modified platelet-rich plasma (PRP) using human cell memory (RP-hCM). The control group was treated with an ultrasound-guided PRP injection into the joint capsule. At baseline and post-treatment, all patients underwent both ultrasonography and magnetic resonance imaging (MRI), and the following clinical variables were assessed: the WOMAC score, the Lysholm knee score, the visual analog scale score, and knee instability. In most patients, the clinical outcome was verified using nanoscopy. Results: The median WOMAC, VAS, and LKS scores, as well as knee instability, improved significantly 12 weeks after the procedure in the treatment group (p < 0.001). We found a significantly larger improvement in the assessed parameters in the treatment group compared to the control group (p < 0.001). In the treatment group, all the patients had good and very good clinical outcomes, while 90% of the patients had a normal ACL signal in a follow-up MRI scan. In the control group, a physical examination revealed no changes in knee stability after treatment. Conclusions: This study showed that there is a significant difference in patient experience and the duration of recovery for patients with ACL tears treated with NSBT. The novel nonsurgical method was shown to be repeatable, objective, well documented, standardized, and highly effective.

Keywords: ACL; anterior cruciate ligament tears treatment; nanosurgery and bioengineering treatment.

Figure 1

Flowchart of patient enrollment.

Figure 2

The same knee MRI scans of a patient with an anterior cruciate ligament tear and concomitant lateral tibia condyle fracture before treatment (A) and corresponding MRI scans of the same patient after nanosurgery treatment with an RP-hCM ACL injection (B). The time to return to regular daily activities with full weight-bearing on the injured limb without instability and pain was 9 weeks.

Figure 3

The same knee MRI scans of a patient with an anterior cruciate ligament tear before treatment (A) and corresponding MRI scans after nanosurgery treatment with an RP-hCM injection (B). A nanoscopic view of the normal, healed ACL (C).

Figure 4

The same knee MRI scans of a patient with an anterior cruciate ligament tear before treatment (A) and corresponding MRI scans after nanosurgery treatment with RP-hCM injection (B). A nanoscopic view of the normal, healed ACL (C).

Figure 5

The same knee MRI scans of a patient with an anterior cruciate ligament tear before treatment (A) and corresponding MRI scans after nanosurgery treatment with an RP-hCM injection (B).

Figure 6

The same knee MRI scans of a patient with an anterior cruciate ligament tear before treatment (A) and corresponding MRI scans after nanosurgery treatment with an RP-hCM injection (B).

Figure 7

The same knee MRI scans of a patient with an anterior cruciate ligament tear before treatment (A) and corresponding MRI scans after nanosurgery treatment with an RP-hCM injection (B).

Figure 8

The same knee MRI scans of a patient with an anterior cruciate ligament tear before treatment (A) and corresponding MRI scans after nanosurgery treatment with an RP-hCM injection (B). A nanoscopic view of the normal, healed ACL (C).

Figure 9

The same knee MRI scans of a patient from the control group with an anterior cruciate ligament tear before treatment (A) and corresponding MRI scans after treatment with PRP injection (B).