Recently Johnson & Johnson Medical Devices Companies, through the DePuy Synthes franchise, announced the U.S. launch of DYNACORD Suture on HEALIX ADVANCE Anchors to repair soft tissue, such as the rotator cuff (shoulder). The new announcement prompted Medical Device News Magazine to interview Rodrigo Diaz, MD Medical Director for DePuy Synthes. Dr. Diaz elaborated on the innovation of DYNACORD Suture.

MDNM:  What percentage of people over the age of 60 present with a full rotator cuff tear where the rotator cuff tendon is no longer attached to the head of the upper arm bone? Please cite a journal reference as well. 

Rodrigo Diaz, MD Medical Director for Joints, Mitek and Power Tools, DePuy Synthes (Medical Device News Magazine)
Rodrigo Diaz, MD
Medical Director for Joints, Mitek and Power Tools, DePuy Synthes (Medical Device News Magazine)

DR. DIAZ: An estimated 25 percent of people over the age of 60 have a full tear of the rotator cuff 1 from either an acute injury, chronic overuse, or gradual degeneration while aging. The goal of rotator cuff repair surgery is to reattach the tissue to the upper arm bone, or humerus, using suture and an anchor.

MDNM: Describe the rotator cuff procedure and the role of the DYNACORD suture.

DR. DIAZ: In rotator cuff repair procedures, surgeons reattach the tissue to the upper arm bone, or humerus, using high-strength orthopedic suture and an anchor. However, the formation of gaps between the tissue and bone are common problems after surgery that can lead to repair failure.2  To be successful, surgeons are looking for high-strength orthopedic sutures that maintain tendon-to-bone compression throughout the healing process to help patients get moving again.

MDNM:  Describe the goals of the traditional arthroscopic rotator cuff surgery using suture and anchor and why there is a 20% failure rate.

DR. DIAZ: The goal of this type of surgery is to help reduce pain, improve motion, and restore joint function for the patient. In many cases, rotator cuff repair surgery may be performed using a minimally invasive approach called arthroscopy that is associated with reduced complications and enhanced patient satisfaction. However, failure of tendon healing after a rotator cuff repair occurs in approximately 20 percent of patients, depending on the size of the tear.3 Over time after surgery, many high strength sutures can experience laxity, or loss of tension, which can cause a loss of compression between the tendon and the bone providing a less stable repair construct.4 The suture can also cut through the tendon and introduce a gap in the tissue, which can lead to a lack of tissue approximation to bone and compromise healing.4   When suture is tied, there is the potential for the knot construct to slip or loosen over time thus reducing the security of the repair.Lastly, the patient is required to keep the arm immobile in a sling for a period of time, and prematurely using it can cause gaps to form.3

MDNM: What about revision surgery?

DR. DIAZ: Clinical literature has shown that post-surgical gap formations, due to suture laxity, may lead to revision surgery. In fact, the percentage of revision surgeries has been reported to be as high as 30% for isolated tears in a rotator cuff tendon called the supraspinatus and as high as 90% for large to massive tears.5

  • Revision surgery is not only costly to a healthcare system but it may affect patients’ and caregivers’ well-being negatively.

  • In a cost-constrained healthcare system, avoidance of a revision surgery may lead to improved overall care and saves valuable resources.

  • One analysis showed that just a two percent reduction in revision rates per year would yield a potential cost savings of $156.3 million in the US.6

MDNM:  How exactly does DYNACORD Suture promote stability? 

DR. DIAZ:  DYNACORD Suture is a high-strength suture that is uniquely designed to respond to changes in repair tension that occur over time and maintain stability during the healing process, helping to maintain compression and tissue-to bone contact. In addition to providing high initial fixation strength, the DYNACORD Suture is designed to maintain strong tissue to bone compression, called approximation, throughout the healing period. Close tissue approximation is critical to a successful repair and healing.

MDNM:  The design of the suture:  As DYNACORD Suture consists of two outer sheaths of braided fibers and a core made of silicone and salt, how does the internal salt-filled core help DYNACORD Suture maintain a stable repair environment?

DR. DIAZ: DYNACORD Suture consists of two outer sheaths of braided fibers and a core made of silicone and salt. This internal salt-filled core helps DYNACORD Suture maintain a stable repair environment.

  • After DYNACORD Suture is placed in the body during surgery the salt particles within the silicone core dissolve, leaving behind a porous structure within the silicone core.

  • These small voids are filled with surrounding fluid as the core hydrates, which causes the braided sheath to expand outward, and the suture to shorten in length. This happens if the repair loses tension, to maintain a stable repair environment throughout the healing process.

Because of this design that allows the suture to respond to changes in postoperative tension, DYNACORD Suture is designed to maintain a strong and stable soft tissue repair and help reduce gap formation.

MDNM:  Is DYNACORD Suture currently being used in other orthopedic surgical procedures? If not, will it eventually be indicated for use in other orthopedic procedures?

DR. DIAZ: The HEALIX ADVANCE Anchor with DYNACORD Suture is indicated for use in soft tissue to bone fixation for certain shoulder, foot/ankle, knee, elbow and hip procedures, as specified in the product’s Instructions for Use.

MDNM:  What training is being offered to orthopedic surgeons regarding use of the DYNACORD Suture?  

DR. DIAZ: DYNACORD Suture does not require specific training, however, surgeon education is being conducted at the various professional society meetings including recently at the San Diego Shoulder and Elbow Course (ESCH, June 20-23, San Diego), at the upcoming American Orthopedic Society for Sports Medicine (AOSSM, July 5-8, San Diego), and the Orthopedic Summit Evolving Techniques (OSET, December 5-8, Las Vegas).

Dr. Diaz noted, “The launch of DYNACORD Suture is the latest example of how DePuy Synthes Mitek Sports Medicine is responding to clinical unmet needs in soft tissue repair with an innovative portfolio solution addressing a full spectrum of sports medicine needs in shoulder, knee and hip arthroscopy to improve patient care.”

Editor’s Note: Refer to video for additional information.

References

[1] Aliprandi, A et al. Reporting rotator cuff tears on magnetic resonance arthrography using the Snyder’s arthroscopic classification. World J Radiol 2017 March 28; 9(3): 126-133.

[2] Hurwit, D. Viscoelastic Properties of Common Suture Material Used for Rotator Cuff Repair and Arthroscopic Procedures. Arthroscopy. 2014 Nov;30(11):1406-12

[3] Lädermann A, Denard PJ, Burkhart SS. Management of failed rotator cuff repair: a systematic review. J ISAKOS. 2016 Jan;1(1):32-37.

[4] Hurwit, D. Viscoelastic Properties of Common Suture Material Used for Rotator Cuff Repair and Arthroscopic Procedures. Arthroscopy. 2014 Nov;30(11):1406-12

[5] Yeh ML, Hong CK, Su WR, et al. Current Biomechanical Concepts of Suture Bridge Repair Technique for Rotator Cuff Tear. International Journal of Orthopaedics 2015;23(3):284-288.

[6] DYNACORD™ Suture for Soft Tissue Repair Procedures: Value Analysis Brief. 090516-180421.