Applying regenerative medicine to common shoulder surgery could impact the need for follow-up revision surgery in some patients, according to a Mayo Clinic study of real-world evidence.
Mayo Clinic researchers analyzed the largest available data set to determine whether adding bone marrow aspirate concentrate to repaired tissue after standard rotator cuff surgery would improve patient outcomes. Bone marrow aspirate is fluid taken from a patient’s bone marrow that contains concentrated growth factors, stem cells, and other specialized cells that can regenerate tissue and cartilage.
The analysis identified 760 patients who had an added regenerative intervention to augment rotator cuff repair surgery. These patients were compared to 3,888 patients who had not undergone any biological intervention at the time of surgery. The data indicated that 114 patients who opted for bone marrow aspiration concentrate at the time of surgery were less likely to need a second surgery.
The results of the Mayo Clinic study are published in the Orthopedic Journal of Sports Medicine.
“The data we analyzed suggests an almost three-fold reduction in revision surgery in patients who received bone marrow aspiration concentrate, compared to those who did not,” says Bradley Schoch. , MD, orthopedic surgeon and principal investigator. “This procedure is increasingly used in the practice of orthopedic surgery and is commonly added as a surgical adjunct to rotator cuff tears.”
A rotator cuff tear – the separation of tendons from the shoulder joint – is a leading cause of pain and disability for millions of people in the United States. Arthroscopic surgery is the standard of care for repairing symptomatic rotator cuff tears. However, depending on the size of the tear and the quality of the tendon, this surgery may fail, sometimes requiring revision surgery.
Regenerative medicine is an emerging field that seeks new biotherapies to restore damaged cells, tissues and organs. One area of interest is biologics that use sources from the human body – cells, blood, enzymes, tissues, genes or genetically modified cells – for use in drugs. The Center for Regenerative Biotherapeutics at Mayo Clinic is at the forefront of this movement and supports this study as part of its goal to bring new regenerative biotherapies to practice.
Study real-world evidence
Preclinical research suggests the potential benefits of orthobiologics, such as Bone Marrow Aspirate Concentrate, for healing damaged tendons. A few clinical trials have been conducted in an attempt to establish scientific evidence of cure in humans. However, insurance considers orthobiologics experimental and does not reimburse for these procedures.
To expedite Food and Drug Administration (FDA) approval of promising therapies, Congress passed the 21st Century Act in 2016 that enables data from real-world evidence to support regulatory decision-making. The FDA can now consider data from sources other than clinical trials, such as risks and benefits documented in electronic health records, lab reports, and billing activities. In this Mayo Clinic study, researchers looked at data from major insurance billing codes.
“The primary objective of this study was to use a national administrative database to determine the association of bone marrow aspiration concentrate applied at the time of rotator cuff repair on rates of revision surgery, compared to matched controls. It provides additional support for randomizing controlled trials that often take years to complete and are often not definitive,” says Shane Shapiro, MD, orthopedic surgeon and medical director of Regenerative Medicine Treatment Suites at the Mayo Clinic in Florida “This type of study allows stakeholders and health insurance companies to assess the risks, benefits, and economic value of emerging medical interventions.”
“Our results suggest that patients undergoing rotator cuff repair surgery may benefit from the addition of bone marrow aspirate cells to surgically repair tissue,” says Christopher Camp, MD, orthopedic surgeon at Mayo Clinic and co. – author of the study. “However, the exact therapeutic mechanisms of its action are still somewhat unclear.”
The study team also analyzed the results of 646 patients who chose platelet-rich plasma at the time of rotator cuff repair surgery and found no measurable difference, compared to patients without interventions. regenerative. Platelet-rich plasma, also known as PRP, is an orthobiological procedure in which platelets containing growth factors and healing potential are extracted from the blood and returned to the patient at the point of injury. Platelet-rich plasma has shown potential to relieve other conditions, such as arthritis of the knee.
Clinical trials may offer stronger documentation of the benefits of orthobiologics for rotator cuff injuries. Higher-level clinical studies focusing on surgical factors will be needed to confirm whether bone marrow aspiration concentrate can prevent the need for a second rotator cuff repair surgery.
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