San Diego—February 18, 2011
“I would not recommend platelet-rich fibrin matrix [PRFM] as we used it in this study until we gain further information,” said Scott Rodeo, M.D. He led the study and is co-chief of the Sports Medicine and Shoulder Service and professor of Orthopedic Surgery at HSS. PRP has been used extensively in orthopedic surgeries and the study begs the question of whether it has been used prematurely in some cases, before sufficient evidence has accumulated to back up its usefulness.
“The general PRP has been used extensively in orthopedics and in other areas,” Dr. Rodeo said. “There are a number of different types of PRP, and I think we need more information to identify the appropriate doses and the appropriate timing of giving it.”
For roughly 15 years, PRP has been used to improve healing in various surgeries, especially oral and maxillofacial surgery, with varying degrees of success. Because there is a rate of incomplete or failed healing after rotator cuff repair surgeries, investigators at HSS set out to test whether a type of PRP, platelet-rich fibrin matrix (PRFM), could improve tendon healing in this surgery.
Platelets have proteins that are known to improve cell proliferation, cell division, and cell migration, a myriad of processes that can encourage healing. To create PRP, doctors extract blood from a patient and then use a centrifuge to isolate the platelets. In the study presented at AOSSM, the investigators then used calcium chloride to make a gummy substance that they could implant in the patient. “It is essentially a material that can be actually sutured in at the time of surgery. It’s almost like chewing gum in consistency,” Dr. Rodeo said. “In rotator cuff repair, we attached it to a suture which was used to reattach the tendon to the bone.” The substance is then supposed to stimulate healing.
In the prospective, patient-blinded trial, 79 patients were randomized to rotator cuff surgery with or without an implant of PRFM. Patients in both groups received the same rehabilitation after surgery. The primary end point of the study was tendon healing evaluated by ultrasound at 6 to 12 weeks. Investigators also analyzed shoulder outcome scales and strength measurements. Overall, there was no difference in tendon-to-bone healing between the PRFM and the control group. There were also no significant differences in the shoulder outcome scales between groups. If any difference was identified, it was slightly negative—patients in the PRFM group showed more tendon defects at 12 weeks, although the difference was not statistically significant.
“There are a number of variables that we need to better control including dosing and timing,” Dr. Rodeo said. He pointed out that only one injection was used in the study and that perhaps repeat injections are needed.
He also said that a major issue that needs tackling is the variability in how PRP is made. “The bigger issue is that there is a lot of variability from patient to patient. There are inter-individual variations, potentially huge variations in my platelet count versus your platelet count and how many proteins are in my cells versus your cells,” Dr. Rodeo said. He said studies are needed to shed light on how this affects the product that is produced.
“Before this study, we knew that platelets had the potential to improve healing and now we know that in the dose and the type used in this study that it did not have a positive effect on rotator cuff repairs,” Dr. Rodeo said. “We realize that tendon biology is very complex and it is a bit of a pie in the sky to think that one injection would make a huge difference. I don’t think the study indicates that the material has no use, I think it just points out that there are just so many variables that we need better information about.”
The Effect of Platelet-Rich Fibrin Matrix on Rotator Cuff Tendon Healing (Paper 577)
Friday, Feb. 18, 8:48 a.m. – 8:54 a.m. San Diego Convention Center, Room 7.
About HSS | Hospital for Special Surgery
HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the ninth consecutive year) and No. 3 in rheumatology by U.S.News & World Report (2018-2019). Founded in 1863, the Hospital has one of the lowest infection rates in the country and was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. The global standard total knee replacement was developed at HSS in 1969. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State. In 2017 HSS provided care to 135,000 patients and performed more than 32,000 surgical procedures. People from all 50 U.S. states and 80 countries travelled to receive care at HSS. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. The HSS Global Innovation Institute was formed in 2016 to realize the potential of new drugs, therapeutics and devices. The culture of innovation is accelerating at HSS as 130 new idea submissions were made to the Global Innovation Institute in 2017 (almost 3x the submissions in 2015). The HSS Education Institute is the world’s leading provider of education on the topic on musculoskeletal health, with its online learning platform offering more than 600 courses to more than 21,000 medical professional members worldwide. Through HSS Global Ventures, the institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally.