Clinical Site Coordinator Regenative Labs Pensacola, Florida
Abstract Title: Safety and Efficacy of Wharton’s Jelly Connective Tissue Allograft for Rotator Cuff Tears: Findings from a Retrospective Observational Study
Background: The shoulder, being a ball-and-socket joint, is considered to be the most mobile and unstable joint, making it highly susceptible to injury. An important segment of the shoulder is the rotator cuff (RC) which allows a wide variety of movements and offers stability to the glenohumeral joint through the contraction of several muscles. Many shoulder pain patient visits can be traced to an RC defect. Increases in RC defects may include factors such as age, hand dominance, history of trauma, genetics, nicotine use, and hypercholesterolemia [1]. The most common nonsurgical treatment plans include NSAIDS, physical therapy, and injections like platelet-rich plasma (PRP) and hyaluronic acid (HA)(2,3). Although conservative treatments have a typically high rate of success, surgery is still a frequent option and the older population takes much longer to recover, with high risks of re-injury. Up to 70% of people over 70 have been affected by RC defects, and annually, there are over 250,000 rotator cuff repairs in the United States, estimated $1.2 to $1.6 billion USD in healthcare expenditures [4,5]. When considering RC repair or reconstruction, there is no conclusive best practice protocol that accounts for the structural integrity of the tissues.
Purpose/Objectives: The need for alternative medicine with substantial evidence is increasing for long-term rotator cuff improvement. One alternative to standard rotator cuff repairments is Wharton’s Jelly (WJ). Wharton’s Jelly is primarily composed of collagen fiber types I, III, and V, cytokines, proteoglycans, various growth factors, and hyaluronic acid. With each component, WJ can effectively supplement the damaged tissue of musculoskeletal injuries [6]. Recent literature has shown significant improvements in function, joint mobility, and pain relief of patients who received WJ tissue allografts to other structural tissue defects such as degenerated cartilage in the knee or SI (7,8). This study evaluates patient-reported pain scales from patients with structural defects in the rotator cuff who had failed standard conservative care for at least 90 days and then received a WJ tissue allograft directly to the site of defect to determine the safety and efficacy of this alternative care option.
Methods: Eighty-seven patients were examined in this study, with a population of forty-two females and forty-five males. The youngest patient was 36 years old, and the oldest patient was 89 years old, with the average age of the population being 71 years old. Twenty different private practices obtained ProTextTM, an umbilical cord tissue allograft. Under proper sterile techniques and ultrasound guidance, 2 cc of Wharton’s Jelly flowable allograft, or 150 mg of Wharton’s Jelly, was applied to distinctly affected anatomy, the most common being supraspinatus and subscapularis tendon. Patients were observed thirty minutes post-procedure to ensure no adverse reactions to the allograft. All patients were in stable condition and discharged home with instructions to limit shoulder movement for one week. On the day of application, the patients filled out a questionnaire consisting of the numerical pain rating scale (NPRS), the Western Ontario and McMaster Universities arthritis index (WOMAC), and a quality of life scale (QOLS). Patients answered the same questionnaire 30 and 90 days after the initial allograft application. The average scores in each scale were calculated and analyzed to determine any statistical significance and the minimal clinically important difference (MCID) to patients.
Results: Results were obtained and separated into three intervals: day of application, day 30, and day 90. Six scales, including the NPRS, QOLS, total WOMAC, and three WOMAC subsections of pain, stiffness, and function, were used to observe the relative improvements of the affected joint. To ensure the data was significant, a p-value of (0.05) was implemented. Higher values for the NPRS and WOMAC scales indicated increased pain, whereas higher values on the QOLS scale indicated higher quality of life. The NPRS and WOMAC scales observed decreases in numerical values, indicating improvements in pain levels that were statistically significant with p=0.000 and p=0.000 for each scale, respectively. The QOLS scale observed increases in numerical values that proved significant (p=0.003), indicating a higher quality of life. Minimal clinically important differences (MCID) are patient-derived scores reflecting clinical changes that are meaningful to the patient [9]. The NPRS was used as the anchor question for the calculation, and approximately 50% of patients exceeded expectations for improvement, and 72% of patients improved by at least one level in their WOMAC scores.
The NPRS score from the initial application to the 90-day follow-up reported an average 2.76 point reduction for each patient, where the raw scores ranged from 10-1 at the initial visit and 8-0 at the final visit. The highest possible score in the WOMAC is 92 points, with 0 being the lowest. The initial visit reported scores that ranged from 92-4, and the final 90-day visit reported scores that ranged from 89-0, indicating an average 13.5-point decrease. The QOLS saw an increase in points; the average improvement increased by 8.9 points from the initial to final visits, with the initial score range being 112-32 and the final score range being 112-41. Across the sample, significant improvements were reported in all scales, providing evidence that WJ is a safe and effective alternative care option when other conservative protocols fail.
Conclusions/Implications for future research and/or clinical care: Given the success in the application of Wharton’s Jelly allografts, this observational study reports significant decreases in patient-reported NPRS, WOMAC, and QOLS scores. One of the most notable observations was the lack of statistical significance in improvement between age groups, indicating the success of the application regardless of age. Positive results from this study provide a foundation for alternative methods for rotator cuff repair and broaden the scope of how WJ can be used homologously throughout the musculoskeletal system. Wharton’s Jelly has the potential to improve the quality of life and reduce the economic healthcare costs associated with multiple conservative treatments or expensive medical procedures for patients with defects in the rotator cuff.
References:
Agha, O.; Diaz, A.; Davies, M.; Kim, H.T.; Liu, X.; Feeley, B.T. Rotator cuff tear degeneration and the role of fibro-adipogenic progenitors. Ann. N. Y. Acad. Sci. 2021, 1490, 13–28. [PubMed]
Everts, P.A.; Lana, J.F.; Onishi, K.; Buford, D.; Peng, J.; Mahmood, A.; Fonseca, L.F.; van Zundert, A.; Podesta, L. Angiogenesis and Tissue Repair Depend on Platelet Dosing and Bioformulation Strategies Following Orthobiological Platelet-Rich Plasma Procedures: A Narrative Review. Biomedicines 2023, 11, 1922. [Google Scholar] [CrossRef]
Bansal, S.; Raja, B.S.; Niraula, B.B.; Regmi, A.; Choudhury, A.K.; Sharma, D.; Dhingra, M. Efficacy of hyaluronic acid in rotator cuff pathology compared to other available treatment modalities: A systematic review and meta-analysis. J. Orthop. Rep. 2023, 2, 100157. [Google Scholar] [CrossRef]
Gupta, A.; El-Amin, S.F.; Levy, H.J.; Sze-Tu, R.; Ibim, S.E.; Maffulli, N. Umbilical cord-derived Wharton’s jelly for regenerative medicine applications. J. Orthop. Surg. Res. 2020, 15, 49. [CrossRef] [PubMed]
Timmons RB, Sugaya K, Bane LD. Homologous Use of Allogeneic Umbilical Cord Tissue to Reduce Knee Pain and Improve Knee Function. Life (Basel). 2022 Feb 9;12(2):260. doi: 10.3390/life12020260. PMID: 35207547; PMCID: PMC8876697.
Lai, A.; Shou, J.; Traina, S.A.; Barrett, T. The Durability and Efficacy of Cryopreserved Human Umbilical Cord Tissue Allograft for the Supplementation of Cartilage Defects Associated with the Sacroiliac Joint: A Case Series. Reports 2023, 6, 12. [Google Scholar] [CrossRef]
Cook CE. Clinimetrics Corner: The Minimal Clinically Important Change Score (MCID): A Necessary Pretense. J Man Manip Ther. 2008;16(4):E82-E83. [PubMed]
