TOTAL SHOULDER ARTHROPLASTY

Shoulder joints, like hips, are ball and socket joints; the ball on the upper arm fits into the socket in the shoulder blade. While typically covered in smooth cartilage, allowing the bones to glide gently around, sometimes the lubricating membrane between the cartilage is damaged or worn away and it can cause severe pain and impairment to the joint.

Common Problems

Osteoarthritis-This type of joint pain is caused by the gradual wearing down on the flexible protective tissue at the end of bones. Often, painful bone spurs develop in the area as well.
Rheumatoid Arthritis-RA is an autoimmune disease where a person’s immune system attacks certain joints, such as the shoulder, and breaks down the healthy tissues. If in more severe stages, it can be beneficial to remove the damaged sections and complete an arthroplasty.
Rotator Cuff Tear-This injury, especially when coupled with arthritis, can be a great candidate for a reverse total shoulder arthroplasty, (a more advanced form of shoulder replacement), as the tissues will not likely be able to restore themselves to normal function.
Fractures- Very severe fractures that are unlikely to heal correctly or cut off blood flow to the injury will likely need the joint to be replaced.
Osteonecrosis-When bones don’t receive adequate blood supply, the tissue can start to die off and cause the bone to collapse.

What is an Arthroplasty?
When a joint takes a certain amount or kind of damage, the best method for repair is to have it replaced in a total shoulder arthroplasty. In this case, both the pieces of the ball and socket will be removed and replaced with metal, plastic, or ceramic prosthetics. The prosthetics are made to replicate natural movement, but there are often certain limitations experienced post-op.

Consult with the Experts
Arthroplasty should not always be the first line of defense. Though it can significantly improve pain, function, and mobility of the joint, it is a life-altering choice. If you are having severe shoulder pain or are looking to have a total shoulder arthroplasty or a screening evaluation, give us a call today at 352-751-2862. During a consultation we’ll be able to create a treatment plan that will work for your case and get you back to doing the things you love!

REGENETEN^◊ Bioinductive Implant

Your Physician is pioneering the use of a breakthrough technology designed for people suffering from rotator cuff tendon tears in the shoulder joint. The REGENETEN Bioinductive Implant, an innovative, minimally invasive solution, goes beyond traditional surgery to help the tendon heal through the induction of new tendinous tissue growth^1,2,3.

A new approach - REGENETEN Bioinductive Implant

Until now, surgeons have focused on addressing the mechanics of the shoulder when repairing a rotator cuff injury, but had limited options to address the biology of healing. Traditional rotator cuff repair procedures involve suturing tendon to bone are associated with potentially long rehabilitation and substantial lifestyle interruption. As a result, many people choose to forego surgery until their pain is severe and everyday tasks are affected. However, as rotator cuff disease progresses, it can become increasingly difficult for your surgeon to repair and small tears can grow in severity and size over time ^4,5,6.

The REGENETEN Bioinductive Implant is an innovative technology designed to address the treatment of rotator cuff disease

The REGENETEN Bioinductive Implant offers a new solution that supports the body's natural healing response to facilitate new tissue growth and potentially disrupt disease progression ^1,2,7-9 by providing a framework for tissue growth.

What is it?

The technology includes a collagen based bioinductive implant about the size of a postage stamp. This implant is delivered arthroscopically through a small incision over the location of your rotator cuff tendon injury. Your physician will secure it in place with small anchors.

How does it work?

Progression of healing

The implant is placed on top of the rotator cuff After implantation, the REGENETEN Bioinductive implant creates an environment that is conducive to healing ^1,2,7 and the proprietary composition facilitates the formation of new tissue ^1,2,7,10.

The implant induces new tissue growth, increasing tendon thickness ^1,2,3.
New tissue allows tendon to restore its natural attachment points in the body³ and is indistinguishable from native tendon at 3 months ^1,2,11.

New tissue integrates and remodels into the healing tendon ^2,7,11 .
Tissue strength comes from the induced tissue, not the implant, which has been shown to be completed absorbed within six months ^{7,11, *}.

How does the REGENETEN Bioinductive Implant benefit you?

No matter where you are in the progression of rotator cuff disease, the REGENETEN Bioinductive Implant has shown consistent healing of rotator cuff tears in both partial and full thickness tears ^1,2,8,12.

Preliminary evidence indicates a reduction in re-tear rates compared to the standard of care in patients with full thickness tears ^3,13
No tear progression was observed by MRI in any patients at 24 months in a study on partial thickness tears (n=13) ¹
Clinically meaningful improvements in pain and function scores at one year compared to pre-operation values ^14,15
Excellent safety profile shows there have been no serious implant-related adverse events reported in the published literature ^1-3,7,12

References

Bokor DJ, Sonnabend D, Deady L, et al. Evidence of healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a collagen implant: a 2-year MRI follow-up. Muscles, Ligaments Tendons J 2016;6(1):16-25.
Schlegel TF, Abrams JS, Bushnell BD, Brock JL, Ho CP. Radiologic and clinical evaluation of a bioabsorbable collagen implant to treat partial-thickness tears: a prospective multicenter study. J Shoulder Elbow Surg. 2018 27(2):242-251.
Bokor DJ, Sonnabend D, Deady L, et al. Preliminary investigation of a biological augmentation of rotator cuff repairs using a collagen implant: a 2-year MRI follow-up. Muscles, Ligaments Tendons J 2015;5(3):144-150.
Henry P, Wasserstein D, Park S, et al. Arthroscopic repair for chronic massive rotator cuff tears: A systematic review. Arthroscopy. 2015;31(12):2472-80.
Bishop J, Klepps S, Lo IK, Bird J, Gladstone JN, Flatow EL. Cuff integrity after arthroscopic versus open rotator cuff repair: A prospective study. J Shoulder Elbow Surg. 2006;15(3):290-299.
Heuberer PR, Smolen D, Pauzenberger L et al. Longitudinal long-term magnetic resonance imaging and clinical follow-up after single-row arthroscopic rotator cuff repair. Am J Sports Med. 2017;45(6):1283-1288.
Van Kampen C, Arnoczky S, et al. Tissue-engineered augmentation of a rotator cuff tendon using a reconstituted collagen scaffold: a histological evaluation in sheep. Muscles, Ligaments Tendons J. 2013;3(3):229-235.
Bokor DJ, Sonnabend DH, et al. healing of partial thickness rotator cuff tears following arthroscopic augmentation with a highly porous collagen implant: a 5-year clinical and MRI follow-up. Muscles, Ligaments Tendons J 2019;9(3):338-347.
McElvany MD, McGoldrick, et al. Rotator cuff repair: published evidence on factors associated with repair integrity and clinical outcome. Am J Sports Med. 2015;43(2)491-500.
Smith + Nephew 2020 REGENETEN Collagen Implant Physical Characteristics. Internal Report
Arnoczky SP, Bishai SK, Schofield B, et al. Histologic Evaluation of Biopsy Specimens Obtained After Rotator Cuff Repair Augmented With a Highly Porous Collagen Implant. Arthroscopy. 2017;33(2):278-283.
Thon SG, O'Malley L, O'Brien MJ, Savoie FH. Evaluation of Healing Rates and Safety With a Bioinductive Collagen Patch for Large and Massive Rotator Cuff Tears: 2-Year Safety and Clinical Outcomes. Am J Sports Med 2019;47(8):1901-1908.
Smith and Nephew 2019. An overview of the outcomes associated with the standard of care for the surgical treatment of rotator cuff tears. Internal Report EO/SPM/REGENETEN/005/v1
McIntyre L, Bishai SK, et al. Patient-reported outcomes following use of a bioabsorbable collagen implant to treat partial and full-thickness rotator cuff tears. Arthroscopy. 201935(8):2262-2271.
Cvetanovich GL, Gowd AK, et al. Establishing clinically significant outcome after arthroscopic rotator cuff repair. J Shoulder Elbow Surg. 2019;28(5):939-948.

*on human biopsy (n=1) and in-vivo sampling

All information provided on this website is for information purposes only. Every patient's case is unique and each patient should follow his or her doctor's specific instructions. Please discuss nutrition, medication and treatment options with your doctor to make sure you are getting the proper care for your particular situation. If you are seeking this information in an emergency situation, please call 911 and seek emergency help.