The benefits of REGENETEN◊ Bioinductive Implant for Patients, Payers and Society

Information for payers and providers in Australia on how Bioinductive Implants can ease the burden of shoulder injury and support better outcomes and wellbeing for patients in Australia.

shutterstock_2360725083.psd

Burden of shoulder injury and conditions in Australia

In Australia, the prevalence of shoulder pain in the general population under 70 years of age has grown dramatically from 7% to 27% over a 20-year period, with lifetime prevalence of shoulder pain reaching 67%.1

In the hospital setting, diseases of the musculoskeletal system and connective tissue were responsible for 745,050 inpatient admissions across both public and private hospitals in Australia in 2021-2022. Moreover, procedures on the musculoskeletal system accounted for 87% of emergency admissions involving surgery in public hospitals during the same period.2

The REGENETEN Implant is a collagen-based bioinductive implant that can be used to treat both partial- and full-thickness rotator cuff tears.

Where does rotator cuff injury fit in?

Rotator cuff disease is a painful, progressive condition resulting from damage and/or injury to one or more of the 4 tendons of the rotator cuff.

Patients with rotator cuff disease usually report pain and weakness in the arm, leading to impaired function and mobility.1 Degenerative damage is predominantly the result of continual wear and tear, while acute injury may be caused by trauma such as sudden heavy lifting, or a fall onto an outstretched arm.3

Rotator cuff disease significantly impairs patients' quality of life and functional capacity. Studies have shown that patients with rotator cuff tears report lower health-related quality of life scores and functional scores compared to the general population.

Disease-Progression.png

Patient quality of life

The average EuroQol-5 Dimensions (EQ-5D) score for measuring quality of life in patients with rotator cuff pathologies was reported as 0.78, significantly lower than the US population norm of 0.83 for adults aged 55-64.3 Functional impairment is also substantial, as evidenced by lower scores on standardised assessments. Patients with partial-thickness rotator cuff tears had a mean preoperative Constant-Murley Score (CMS) of 51.6, compared to population norms of 73-90 for adults aged 51-60.3 Similarly, the mean preoperative American Shoulder and Elbow Surgeons (ASES) score was 46.8 for these patients, substantially below the population norm of 92.2.3

The impact on patients include difficulty sleeping, driving, getting dressed, doing their hair, maintaining household tasks, working, and engaging in leisure activities. The literature and workers compensations frameworks highlight the impact these symptoms can have on patients if symptoms persist or if functional capacity does not improve to the level necessary for their lives.

Progression of rotator cuff disease over time4

Rotator cuff disease is a costly problem for healthcare providers and payers

The economic burden of rotator cuff disease and its treatment is substantial. Direct healthcare costs increase by 78% (from $16,771 to $29,782 per patient annually) following rotator cuff tear diagnosis.5 This significant rise in costs, coupled with the limitations of current treatments, underscores the need for innovative therapies that can promote tendon healing, reduce re-tear rates, and enable faster recovery while decreasing the overall economic burden on both patients and the healthcare system.

Treatment-through-disease.png

Rotator cuff disease is the leading cause of shoulder-related disability in the US seen by orthopaedic surgeons6

Rotator cuff disease is a costly problem for healthcare providers and payers

Current treatment of rotator cuff disease includes conservative and surgical treatment options that do not address factors that lead to progression of degenerative disease

Treatment-through-disease-2.png

In Australia, rotator cuff disease is initially managed with conservative treatments, including rest, NSAIDs, physical therapy, and corticosteroid injections. If these fail to provide relief or restore function after 3-6 months,12 surgical intervention may be considered. While surgery is considered only after the patient has not responded to conservative treatment for 3 to 6 months, it may be given particular consideration for patients who rely heavily on their rotator cuff and have a greater need of recovery – whether due to work, activity level, lifestyle, or age. Common surgical approaches include:

  1. Debridement with or without subacromial decompression (SAD): For grade 1 and 2 tears (≤50% tendon thickness).
  2. Tendon anchor repair: For grade 3 partial-thickness (>50% thickness) and full-thickness tears, using the standard of care.13

Despite providing some relief, these treatments have limitations:

  1. They do not effectively address disease progression or promote substantial tendon healing, leaving patients at risk of further deterioration. They also fail to address the underlying biological factors to improve tendon orientation and tendon thickness.
  2. The risk of re-tears remains high, particularly for larger tears, with studies showing re-tear rates of up to 34% for large and massive full-thickness tears following double-row repair.14
  3. Furthermore, patients require 27 physical therapy visits post-surgery on average.15 This extended recovery period not only impacts patients' quality of life but also contributes to increased healthcare utilisation and costs.
Treatment-through-disease-3.png

Care pathway and current treatment options

Rehabilitation from rotator cuff surgery is a lengthy, painful process that can greatly disrupt everyday life, and recovery from conventional surgery can impact the patients’ ability to work

Treatment-through-disease-4.png

The REGENETEN Implant is a collagen-based bioinductive implant that can be used to treat both partial- and full-thickness rotator cuff tears23

This collagen-based, bioinductive implant is designed to treat various stages of rotator cuff disease, including both partial-thickness and full-thickness tears. REGENETEN supports the body's natural healing process by inducing new tendon-like tissue growth and is compatible with minimally invasive surgical techniques.24

regeneten_illustration.psd

The REGENETEN Implant is a highly porous bioengineered collagen scaffold made from purified type I collagen fibres.25 When rehydrated, the implant is about the size of a postage stamp, making it suitable for arthroscopic application.26 The implant works through two key mechanisms: load reduction, where the physical nature of the implant augments the remaining tendon, reducing stress on the damaged area; and tissue induction, where the bioinductive properties of the implant induce the growth of new tendon-like tissue at the joint.27 The REGENETEN Implant is typically applied arthroscopically, adding only about 10 minutes to the standard rotator cuff repair surgery time.28 It gradually resorbs over time, being completely replaced by native tissue within 6 months.29

REGENETEN Implant application procedure

Safety

The safety and efficacy of the REGENETEN Bioinductive Implant have been demonstrated through multiple clinical studies, including randomised controlled trials, observational studies, and registry data. The safety profile is robust, with no foreign body or inflammatory reactions reported in in vivo and clinical studies.30 Histological assessment showed no signs of inflammatory, scarring, or ischemic changes at 6 months post-implantation,31 and complete resorption of the implant within 6 months was confirmed by human biopsy and in vivo sampling.32

Clinical value

Economic value

References
  1. Musculoskeletal Injuries in Australia: Current Challenges and Opportunities (Page 4).
  2. Musculoskeletal Injuries in Australia: Current Challenges and Opportunities (Page 7).
  3. AAOS. OrthoInfo: rotator cuff tears. 2017. Accessed 07/03/2024. [Accessed online]; Bupa UK. Rotator cuff injury. Accessed 07/03/2024. [Accessed online].
  4. AAOS. OrthoInfo: rotator cuff tears. 2017. Accessed 07/03/2024. [Accessed online]; Patient.info. Tendinopathy and tenosynovitis: tendinosis. 2016. Accessed 07/03/2024. [Accessed online]; Yang et al. J Shoulder Elbow Surg. 2009;18(3):379-85.
  5. Parikh et al. Curr Med Res Opin. 2021;1-13.
  6. Narvy et al. Am J Orthop. 2016;45(1):E7-E11.
  7. Teunis et al. J Shoulder Elbow Surg. 2014;23(12):1913-21.
  8. Millennium Research Group. Orthopedic Soft Tissue Solutions: US 2015 Market Analysis. 2014.
  9. Parikh et al. Curr Med Res Opin. 2021;1-13.
  10. McElvany et al. Am J Sports Med. 2015;43(2):491-500.
  11. Mather et al. J Bone Joint Surg Am. 2013;95(22):1993-2000.
  12. Crookes, Wall, Byrnes, Johnson and Gill et al. Australian Journal of General Practice. 52, 11. Chronic Shoulder Pain. November 2023 [Accessed online].
  13. Strauss et al. Arthroscopy. 2011;27(4):568-80; AAOS. Optimizing the management of rotator cuff problems: guideline and evidence report. 2010; Matava et al. Am J Sports Med. 2005;33(9):1405-17; Papalia et al. Br Med Bull. 2010;99(1):141-54.
  14. Hein et al. Arthroscopy. 2015;31(11):2274-81.
  15. Dickinson et al. J Shoulder Elbow Surg. 2017;26(5):915-22.
  16. AAOS. OrthoInfo: rotator cuff tears. 2017. Accessed 07/03/2024. [Accessed online].
  17. AAOS. OrthoInfo: rotator cuff tears. 2017. Accessed 07/03/2024. [Accessed online].
  18. Matthewson et al. Adv Orthop. 2015; Yamanaka et al. Clin Orthop Relat Res. 1994(304):68-73; Strauss et al. Arthroscopy. 2011;27(4):568-80; Kartus et al. Arthroscopy. 2006;22(1):44-9; Kamath et al. J Bone Joint Surg Am. 2009;91(5):1055-62.
  19. Acevedo et al. J Bone Joint Surg Am. 2014;96(14):e123; 2. Chuinard. OKOJ. 2013:11(11).
  20. Dickinson et al. J Shoulder Elbow Surg. 2017;26(5):915-22.
  21. Acevedo et al. J Bone Joint Surg Am. 2014;96(14):e123.
  22. Manaka et al. Clin Orthop Relat Res. 2011;469(6):1660-6.
  23. Bokor et al. Muscles, Ligaments Tendons J. 2016;6(1):16-25; Van Kampen al. Muscles, Ligaments Tendons J. 2013;3(3):229-35; Schlegel et al. J Shoulder Elbow Surg. 2018;27(2):242-51.
  24. Micheloni et al. Acta Biomed. 2020;91(14-s): e2020004.
  25. Smith & Nephew. Internal report: REGENETEN Collagen Implant Physical Characteristics. 15009769. 2020.
  26. Bokor et al. Muscles, Ligaments Tendons J. 2016;6(1):16-25; Van Kampen al. Muscles, Ligaments Tendons J. 2013;3(3):229-35.
  27. Bokor et al. Muscles, Ligaments Tendons J. 2016;6(1):16-25; McElvany et al. Am J Sports Med. 2015;43(2):491-500; Material and Structural Testing Core, Mayo Clinic 2019. Internal Report. EO/SPM/REGENTEN/001/V1; Bokor et al. Muscles Ligaments Tendons J. 2019;9(3):338-47; Schlegel et al. J Shoulder Elbow Surg. 2018;27(2):242-51; Bokor et al. Muscles Ligaments Tendons J. 2015;5(3):144-50; Thon et al. Am J Sports Med. 2019;47(8):1901-8; Van Kampen et al. Muscles, Ligaments Tendons J. 2013;3(3):229-35; Van Kampen. Basic science fundamentals of the Rotation Medical Bioinductive Implant. 2015.Micheloni et al. Acta Biomed. 2020;91(14-s): e2020004.
  28. Micheloni et al. Acta Biomed. 2020;91(14-s): e2020004.
  29. Arnoczky et al. Arthroscopy. 2017;33(2):278-83; Van Kampen et al. Muscles Ligaments Tendons J. 2013;3(3):229-35; Camacho-Chacon et al. J Exp Orthop. 2022;9(1):1-7.
  30. Arnoczky et al. Arthroscopy. 2017;33(2):278-83; 2. Van Kampen et al. Muscles Ligaments Tendons J. 2013;3(3):229-35; 3. Camacho-Chacon et al. J Exp Orthop. 2022;9(1):1-7; 16. Camacho-Chacon et al. J Shoulder Elbow Surg. 2024;S1058-2746(24):00323-9.
  31. Camacho-Chacon et al. J Exp Orthop. 2022;9(1):1-7.
  32. Van Kampen et al. Muscles, Ligaments Tendons J. 2013;3(3):229-35; Arnoczky et al. Arthroscopy. 2017;33(2):278-83.
  33. Bokor et al. Muscles Ligaments Tendons J. 2016;6(1):16-25; 2. Schlegel et al. J Shoulder Elbow Surg. 2018;27(2):242-51.
  34. Schlegel et al. J Shoulder Elbow Surg. 2021;30(8):1938-48; 2. Schlegel et al. J Shoulder Elbow Surg. 2018; 27(2):242-251.
  35. Ruiz Iban et al. Arthroscopy. 2023;S0749-8063(23)01018-6.
  36. McIntyre et al. Arthrosc Sports Med Rehabil. 2021;3(5):e1473-9.
  37. Bushnell et al. J Shoulder Elbow Surg. 2022;31(12):2532-41.
  38. Bokor et al. Muscles Ligaments Tendons J. 2019;9(3):338-47; Bokor et al. Muscles Ligaments Tendons J. 2016;6(1):16-25; Schlegel et al. J Shoulder Elbow Surg. 2021;30(8):1938-48; Camacho-Chacon et al. J Exp Orthop. 2022;9(1):1-7.
  39. McIntyre et al. Arthrosc Sports Med Rehabil. 2021;3(5):e1473-9; Acevedo et al. J Bone Joint Surg Am. 2014;96(14):e123; Dickinson et al. J Shoulder Elbow Surg. 2017;26(5):915-22; Gholson et al. J Surg Orthop Adv. 2015;24(2):125-9; Camacho-Chacon et al. J Shoulder Elbow Surg. 2024;S1058-2746(24):00323-9.
  40. Aroke et al. J Manag Care Spec Pharm. 2018;24(3):214-24; Scully et al. JAMA Surg. 2018;153(1):37-43; Acevedo et al. J Bone Joint Surg Am. 2014;96(14):e123; McIntyre et al. Arthroscopy. 2019;35(8):2262-71; Arshi et al. Arthroscopy. 2015;31(12):2392-9.e1; 6. Dickinson et al. J Shoulder Elbow Surg. 2017;26(5):915-22; Bushnell et al. Orthop J Sports Med. 2021;9(8):23259671211027850.
  41. Bureau of Labor Statistics. 2023. Accessed 07/03/2024. [Accessed online]; Acevedo et al. J Bone Joint Surg Am. 2014;96(14):e123; Bushnell et al. Orthop J Sports Med. 2021;9(8):23259671211027850. McIntyre et al. Arthrosc Sports Med Rehabil. 2021;3(5):e1473-9.
  42. Bureau of Labor Statistics. 2023. Accessed 07/03/2024. [Accessed online]; 2. Acevedo et al. J Bone Joint Surg Am. 2014;96(14):e123; 3. Bushnell et al. Orthop J Sports Med. 2021;9(8):23259671211027850. 4. McIntyre et al. Arthrosc Sports Med Rehabil. 2021;3(5):e1473-9.
  43. McIntyre et al. Arthrosc Sports Med Rehabil. 2023;11;5(2):e367-e374.
  44. Higgins Paper #SS-28. Presented at: Arthroscopy Association of North America Annual Meeting; April 25-27, 2013; San Antonio.

Title

Text

Explore