Question:
In patients having arthroscopic rotator cuff repair, does augmentation with autologous platelet-rich fibrin matrix lead to improvement in shoulder function and better magnetic resonance imaging (MRI) results than nonaugmented repair?
Design:
Randomized (allocation concealed), blinded (outcome assessors and statistical analysts), controlled trial with a mean of 20.2 months of follow-up.
Setting:
The Orthopaedic and Trauma Surgery department of Ospedale Civile, Jesi, Italy.
Patients:
Eighty-eight patients (mean age, fifty-five years; 55% women) with a rotator cuff tear requiring surgical repair. Exclusion criteria were inflammatory joint disease, irreparable full-thickness tear, symptomatic arthritis of the acromioclavicular joint, rotator cuff arthropathy, pathologic abnormalities of the subscapularis tendon, Workers’ Compensation claims, or previous surgery on the affected shoulder. All patients had clinical follow-up, and seventy-eight patients (89%) had radiographic results.
Intervention:
Patients were allocated to rotator cuff repair and augmentation with platelet-rich fibrin matrix (n = 43) or rotator cuff repair alone (n = 45). The platelet-rich fibrin matrix was prepared by drawing 9 mm of venous blood from each patient by means of standard venipuncture with use of a sterile vacuum tube containing trisodium citrate and a thixotropic polyester separator gel. The red blood cells and platelet-rich plasma were separated in a standard centrifuge, and the platelet-rich plasma was transferred to a 35-mm Wheaton bottle containing calcium chloride and was placed back in the centrifuge. The final product was a membrane of autologous suturable fibrin that had to be used within thirty minutes.
Main outcome measures:
The primary outcome was the difference between groups in terms of change from baseline in the Constant score, a rating scale used to evaluate shoulder pain (15 points), activities of daily living (20 points), range of movement (40 points), and strength (25 points), for a total of 100 points. Higher scores indicated better function. The secondary outcome was MRI evaluation of the integrity of the repaired rotator cuff.
Main results:
Analysis was by intention to treat. A total sample size of eighty-two patients (forty-one in each group) was required to achieve significance at a 0.05 level with 95% power with use of the Constant score at sixteen months after surgery. Both the augmented and nonaugmented groups showed an improvement in Constant score from preoperative ratings with no significant differences between groups (Table). The groups were not different in terms of the MRI evaluation of tendon thickness or the size of the tendon footprint. More patients in the platelet-rich fibrin matrix-augmentation group had a light and diffused increase in tendon signal intensity (p < 0.001).
Conclusion:
In patients having arthroscopic rotator cuff repair, augmentation with autologous platelet-rich fibrin matrix did not lead to greater improvement in shoulder function or structural outcome than nonaugmented repair.
Platelet-rich plasma is a hot topic as a result of anecdotal reports from high-profile elite athletes using this innovation as an adjuvant to the rehabilitation of injuries. Although basic science evidence exists, less clinical evidence is available to support the use of platelet-rich plasma for soft-tissue healing1.
In this well-designed study by Castricini and colleagues, no patients were lost to follow-up. However, the study evaluated a single clinical outcome with no patient-derived quality of life scores. Although clinical scores improved for both groups, there was no difference between the two groups. However, the success of a properly performed surgical repair of small to medium-sized rotator cuff tears is high. Thus, if good results already exist, then augmentation with platelet-rich fibrin matrix may not have the ability to show improvement. Future trials will need to determine if there is any benefit in treating those conditions for which surgery has shown limited success, such as larger tears. Furthermore, the details of actual postoperative rotator cuff thickness and footprint size would have been helpful.
There are inherent differences in the various platelet-derived preparations. In this study, the authors used platelet-rich fibrin matrix, which has the advantage that it does not require the use of anticoagulants, making surgical implantation of the gel-like implant more practical2. A similar study involving platelet-rich plasma globules showed clinical improvement and a lower re-tear rate at three months3. Studies must include and consider details of the platelet-derived therapy preparation and a description of the use of activating agents and anticoagulants. This study showed no benefit. Future research should evaluate the benefits of platelet-rich plasma with different surgical interventions and/or different preparations.
References
Taylor
DW;
Petrera
M;
Hendry
M;
Theodoropoulos
JS. A systematic review of the use of platelet-rich plasma in sports medicine as a new treatment for tendon and ligament injuries. Clin J Sport Med.
2011Jul;21(
4):344-52.[PubMed][CrossRef]
Dohan
DM;
Choukroun
J;
Diss
A;
Dohan
SL;
Dohan
AJ;
Mouhyi
J;
Gogly
B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part I: technological concepts and evolution. Oral Surg Oral Med Oral Pathol Oral Radiol Endod.
2006;101:e37-44.[PubMed][CrossRef]
Hrnack
SA;
Barber
FA;
Hapa
O. Rotator cuff repairs augmented by platelet rich plasma evaluated with MRI and clinical outcomes (SS-08). J Arthroscop Relat Res.
2010;26:e4-e5.[CrossRef]