Preliminary ACL RCT Results. Regenexx (6/1/17)

Transcription

1 Preliminary ACL RCT Results Regenexx (6/1/17)

2 Purpose We initiated this RCT to validate our ACL regeneration results seen in clinic. ACL reconstruction surgery is invasive and has been shown to lead to early-onset osteoarthritis, while the graft fails to mimic native ACL structure or function. As part of our mission to deliver optimal patient outcomes and prevent unnecessary, costly and invasive surgeries, we treat torn ACLs with autologous bone marrow concentrate. We are currently compiling results from our Knee Osteoarthritis RCT and hope to share them with you soon.

3 Details Patient information is gathered before treatment, then at 1, 3, 6, 12, 18 and 24-months posttreatment. This information includes: Percent Improvement. Patients are asked to report on their subjective percent improvement compared to their pre-treatment condition on a -100% worsened to 100% improved scale, with 0% implying no change. For data presentation, scores are floored at 0% to match the Single Assessment Numerical Evaluation (SANE) score commonly reported in the literature, which reports improvement from 0% to 100%. Numeric Pain Scale (NPS). Patients are asked to rate their pain on a 0 to 10 scale, with 0 meaning no pain and 10 meaning the worst possible pain. Lower Extremity Functional Score (LEFS) and International Knee Documentation Committee (IKDC) are functional questionnaires associated with daily living and the ability to perform various tasks, ranging from walking between rooms to making sharp turns while running. Each metric is analyzed for differences over time compared to baseline conditions, and treatment and exercise group outcomes are compared at applicable post-treatment time points. The N s below each plot show the number of patients reporting at each time point. Patients were randomized to either a control (exercise) group or the treatment group. Patients can then cross-over to the treatment group at 3-months. Therefore, treatment N s will be larger than exercise N s because all those who were randomized to the exercise group crossed over to the treatment group.

4 Modified SANE Score SANE (Single Assessment Numeric Evaluation) is a metric assessing subjective percent improvement from 0% to 100% Outcomes after receiving treatment are significantly higher than outcomes after performing exercise at the 3-month time point After receiving treatment, SANE scores beyond 3- months are significantly higher than 1-month scores, showing patients experience continued healing over time. N's: Treatment: 19, 18, 19, 14, 7, 6. Exercise: 8, 9. **= p<0.01, *=p< =p<0.01 Average 3-month outcomes for the exercise group were <25% compared to >75% for the treatment group at 24-months.

5 Numeric Pain Scale NPS is scored from 0 to 10, with lower scores implying less pain. Although ACL tears are not typically high paingenerators, scores at 6-months post-treatment are significantly lower than baseline scores. Exercise group average NPS scores are actually higher than baseline at 3-months. N's: Treatment: 23, 21, 19, 19, 14, 7, 6. Exercise: 10, 8, 10, 1. **= p<0.01

6 LEFS and IKDC LEFS (Lower Extremity Functional Scale) and IKDC (International Knee Documentation Committee) are functional questionnaires assessing ease/difficulty of daily living and various activities. 3-month scores are significantly higher for the treatment group compared to the exercise group for both metrics (p<0.01). Scores beyond 1-month post-treatment are significantly higher than baseline scores (p<0.01) for both metrics. Top plot: N's: Treatment: 24, 20, 18, 19, 14, 7, 5. Exercise: 9, 8, 10, 1. Bottom plot: N's: Treatment: 24, 21, 18, 19, 14, 7, 6. Exercise: 10, 8, 10, 1. **= p<0.01, ++=p<0.01 Exercise scores fail to show significant differences from baseline at either time point.

7 LEFS Differential Scores LEFS (Lower Extremity Functional Scale) differential scores are calculated by taking the difference between a patient s post-treatment score and their baseline score. Post-treatment differential scores continuously increase through 18-months, while exercise differential scores decrease between 1 and 3- months. N's: Treatment: 20, 18, 19, 14, 7, 5. Exercise: 7, 8, 1. **= p<0.01

8 Conclusions Receiving treatment leads to significantly better outcomes at 3- months compared to performing exercise. Treatment results are sustained, and improve, through 24-months post-treatment. Regenexx-SD treatment can regenerate native ACLs and help prevent ACL reconstruction surgery. For additional information on Regenexx ACL treatment results, please see our published paper. We have submitted and are awaiting review for a second, more expanded, ACL case series.