Dissertation
Retrospective data review of a randomized, controlled study to evaluate the safety and effectiveness of PDGF rotator cuff for treatment of rotator cuff tears
Doctor of Health Science (D.H.Sc.), Drexel University
16 Feb 2022
DOI:
https://doi.org/10.17918/00001596
Abstract
Tears of the rotator cuff are one of the more common conditions which affect the shoulder. Following rotator cuff repair, focus has turned to strategies to increase the biological response in attempts to improve rotator cuff healing (Kovacevic & Rodeo, 2008; Zhang, Wu, Li, Wang, Lu, & Wong, 2021). Optimal rotator cuff injury reconstruction requires the reinsertion of the tendon at the initial attachment site (tendon footprint) into the bone (Cole et al., 2007; Thomopoulos et al., 2009; Nho et al., 2010; Freislederer, Dittrich, & Scheibel, 2019). Research has shown that without reinsertion of the tendon fibers into the bone, the healed site will have inferior biomechanical properties potentially restricting operation and contributing to greater opportunities for re-injury and the need for revision (Thomopoulos et al., 2009). As a strategy to optimize the healing of these injuries and improve the long-term clinical effects of rotator cuff repair, the delivery of growth factors such as Platelet Derived Growth Factor (PDGF) could improve tendon-to-bone healing and overall patient outcomes. The objective of this study was to determine if PDGF Rotator Cuff is a safe and viable option in reducing rotator cuff tear recurrence without compromising performance compared to the current standard of care of standard suture repair alone. The alternate hypothesis for this research study is: The use of PDGF in conjunction with standard suture repair for treatment of rotator cuff tears will reduce rotator cuff tear recurrence and improve performance compared to standard suture repair alone. The null hypothesis is: The use of PDGF in conjunction with standard suture repair for treatment of rotator cuff tears will not reduce rotator cuff tear recurrence nor improve performance compared to standard suture repair alone. The initial data for PDGF are encouraging despite not showing significance compared to the control. PDGF is a safe alternative to the current standard of care however the overall viability when used in conjunction with standard suture repair has not been fully realized. While the data demonstrate the safety and potential effectiveness of PDGF it also highlights the need for modification of the product design in order to develop a more acceptable delivery system to the treating surgeon. Subsequent studies may result in higher success rates if a different surgical technique is employed and the population size is expanded. RhPDGF-BB has the potential to yield healing rates that are equivalent to, or perhaps higher than, the current standard treatments, including standard suture repair, a treatment that is associated with significant re-tear rates. A longitudinal study is warranted to see if there are differences between the treatments in the incidents of retearing. More research is needed to further explore the potential of PDGF in the treatment of rotator cuff tears.
Metrics
16 File views/ downloads
42 Record Views
Details
- Title
- Retrospective data review of a randomized, controlled study to evaluate the safety and effectiveness of PDGF rotator cuff for treatment of rotator cuff tears
- Creators
- Justin Wayne Moss
- Contributors
- Frances Haider Cornelius (Advisor)
- Awarding Institution
- Drexel University
- Degree Awarded
- Doctor of Health Science (D.H.Sc.)
- Publisher
- Drexel University; Philadelphia, Pennsylvania
- Number of pages
- 75 pages
- Resource Type
- Dissertation
- Language
- English
- Academic Unit
- College of Nursing and Health Professions; Drexel University; Health Sciences
- Other Identifier
- 991020536967104721