Platelet-rich plasma in fibrin matrix to augment rotator cuff repair: a prospective, single-blinded, randomized study with 2-year follow-up
These authors point out that "despite improvements in the mechanical constructs used to repair rotator cuff tears, retear remains a significant issue. Retear rates ranging from 10%-90% depending on the size of the tear, age of the patient, amount of fatty infiltration, and type of repair have been reported. Higher failure rates in patients older than 65 years have been consistently demonstrated".
These authors point out that "despite improvements in the mechanical constructs used to repair rotator cuff tears, retear remains a significant issue. Retear rates ranging from 10%-90% depending on the size of the tear, age of the patient, amount of fatty infiltration, and type of repair have been reported. Higher failure rates in patients older than 65 years have been consistently demonstrated".
They sought to test the concept that application of autologous platelet-rich plasma in fibrin matrix (PRPFM) improves clinical outcomes in patients undergoing arthroscopic rotator cuff repair using a prospective, randomized, single-blinded study of 76 patients. The treatment group underwent arthroscopic rotator cuff repair with PRPFM.
The control group did not receive the PRPFM.
The Simple Shoulder Test scores showed no incremental benefit of PPFM: the improvement was from 45% to 96% for the control group and from 49% to 96% in the PRPFM group.
Strength of the supraspinatus at 24 months by dynamometer testing was 99.8% in the control group and 96.3% in the PRPFM group. Infraspinatus strength was 104% in the control group and 103% in the PRPFM group
MRI's suggested a 19% retear rate for the control group and 7.4% for the PRPFM technique at 6 months.
All of their results showed no statistically significant benefit of PRPFM.
Comment: This is a valuable randomized trial that shows that showed no evidence of added clinical benefit for the PRPFM. If the study had not included the control group, one might conclude that cuff repair with PRPFM argumentation was a "clinically viable technique" because the patients were improved. However, with the inclusion of the control group, it became evident that the addition of PRPFM did not benefit the patients.
Comment: This is a valuable randomized trial that shows that showed no evidence of added clinical benefit for the PRPFM. If the study had not included the control group, one might conclude that cuff repair with PRPFM argumentation was a "clinically viable technique" because the patients were improved. However, with the inclusion of the control group, it became evident that the addition of PRPFM did not benefit the patients.
It is of interest that in spite of the apparently greater rate of retears in the control group, there was no difference in clinical outcomes.
The authors do not provide the incremental time involvement and the incremental cost of the PRPFM approach (see the details at the end of this post below).
In any event, evidence of incremental value for PRPFM was lacking.
Preparation of PRPFM: "Eighteen milliliters of whole blood was drawn from patients by use of sterile technique, transferred to a specially designed tube for centrifugation in a Drucker 755VES general-purpose centrifuge,
and spun for 6 minutes at 1100 RPM. During centrifugation, the heavier red and white blood cellular components moved to the bottom of the tube while the lighter platelets remained at the top in the plasma. A polyester separator gel in the tube sealed the red blood cells and the white blood cells to prevent contamination with the platelets. After processing, 4-4.5 cm3 of leukocyte-poor PRP was transferred to 2 separate tubes containing trace amounts of calcium chloride to replace the calcium that was bound by the citrate and was spun for an additional 15 minutes at 1450 RPM. This second, faster spin using the same centrifuge caused the fibrinogen in the plasma to form a 2-cm3 solid PRPFM in disk-like form. The PRPFM was then removed and fashioned on the back table to fit the size and shape of the tear.
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