The Role of Patient Registry Data and Improving Patient Outcomes

By Dr.Charles Lee Regenesis Stem Cell Center

In a previous post, I outlined the hallmarks of quality that contribute to improved patient outcomes in the use of Bone Marrow Stem Cell (BMSC) and Platelet Rich Plasma (PRP) injections (Interventional Orthobiologics).

These hallmarks include:

1. Extensive physician training and experience in regenerative medicine and Orthobiologic injections.
2. Disclosure of physician name and credentials in advertising.
3. Real-time image-guided injection of orthobiologics.
4. Maintenance of a Treatment Registry to associate patient outcomes with therapeutic strategies.

This month, I will expand on patient Registry Data and analysis's role in improving patient outcomes. In the case of orthobiologic interventions, such data should benchmark patient joint function and chronic pain prior to and following an orthobiologic intervention.

Here at Regenesis, we grade patient joint function and chronic pain prior to regenerative therapy and at one, three, and six months after therapy. We use standard orthopedic scoring questionnaires that include 10 to 42 items to gauge joint symptoms, pain, daily living functionality, sports and recreation functionality, and patient quality of life.

For example, we score patient knee complaints using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Visual Analogue Score (VAS). These scores range from 0 to 100 for the KOOS and 0 to 10 for the VAS. Low KOOS scores are indicative of injured or diseased knees, and high VAS scores indicate high levels of knee pain.

By monitoring post-procedure patient progress, we improve therapy strategies, patient outcomes, and our patient suitability estimates. Our improvement in patient outcomes can be seen in the following histogram and plot of average patient KOOS scores at pre-op and 1-, 3-, and 6-months following therapy. These scores are for patients with a median age of 66 and ranging in age from 43 to 88.

Of note, by month six, half of our patients attained KOOS scores typical of 18 to 34-year-old Americans, with 86 percent attaining higher joint function and reduced pain typical of much younger Americans.

(Combinations of VAS and KOOS scores illustrated above represent multiple knee procedures due to duplicated score combinations across multiple patients).

The scatter plot above tracks individual knee cases in terms of improved pain (VAS) and function (KOOS) at three months following one of two procedures: PRP injections (blue) or Bone Marrow Stem Cell (BMSC), PRP, and Interosseous (IO) Stem Cell injections (Red). As indicated, patients evidenced significant pain and function improvement from the pre-op scatter distribution to their Three-Month Follow-Up. Additionally, patients with very high levels of pain and/or poor joint function experienced life-changing improvements (red and blue dots and arrows). Moreover, due to their advanced age or complicating factors, many of these patients were not candidates for knee replacement.

At Regenesis, our patient registry data speaks to the efficacy of our therapies while allowing us to provide candidate patients with good insight into outcome prospects. It also allows us to continually improve therapy strategies to meet the needs of patients seeking improved quality of life without the pain, extensive recovery, downtime, and complication risks inherent in joint replacement.

If you have questions, visit www.regenesisstemcell.com or schedule a consultation at Regenesis Stem Cell Center by calling (256)715-8193.