The Clinical Problem
Over 4 million patients seek medical treatment each year because of a rotator cuff injury. Many of these patients will require surgery for treatment of their rotator cuff injury. Unfortunately, the failure rate for rotator cuff surgery has been reported to be between 20% and over 90% in many instances. The most common reason for the lack of success of such rotator cuff surgeries is structural failure at the surgical site.

 

BioTend

BioTend is a specialized surgical mesh with
mechanical properties equivalent to human tendon,
allowing it to support function of surgically repaired
tendon and other soft tissues.

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It is specifically designed to reinforce surgical repair of
tendon and other soft tissues, including reinforcement of rotator cuff, patellar,
Achilles, biceps and quadriceps tendons.

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After the repair process is complete, the material dissolves at the surgical site.

 

Rotator Cuff
The rotator cuff is a set of tendons attaching muscles
to the upper arm. The tendons provide stability and

strength to the shoulder.

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Rotator Cuff Tears
The tendons (one or more) may tear or tear away
from the bone, and need to be repaired surgically.
When the surgery is at risk of failure (re-tear), then
BioTend may be used to strengthen the surgical r
epair and increase the chance of successful

long-term repair.

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 Surgical Treatment
Your orthopedic surgeon may recommend surgery if:

• Nonsurgical treatment does not relieve symptoms

• The tear has just occurred and is very painful

• The tear is in the shoulder of the dominant arm of
  an active person

• If maximum strength in the arm is needed for overhead
  work or sports

 

The type of surgery performed depends on the size, shape, and location of the tear. A partial tear may require only a trimming or smoothing procedure, called a " debridement. " A complete tear is repaired by suturing the tendon back together. If the tendon is torn away from where it inserts into the bone of the arm (humerus), it is repaired directly to the bone.
 

Risk of Failure of Rotator Cuff Repair
A review of published studies shows the success of

rotator cuff surgical repair is not guaranteed. As shown
in the table below, when the surgical outcome is
assessed by MRI or ultrasound, the success rate of 
rotator cuff surgery on large and massive tears is low.

 

Rotator Cuff Tear                               Success Rate

Massive (2 or more tendons, >5 cm)      40%

Large (3 – 5 cm)                                        52%

Small to Medium (1 – 3 cm)                     74%

 

Augmentation of Surgical Repair with BioTend
BioTend might be appropriate whenever there is a
risk of a re-tear of the surgical repair. This may be when:

• The tear is massive (greater than 5 cm)

• The tear is large (3 – 5 cm)

• The tear is a repair of a previously surgically repaired
  rotator cuff

• The tear is chronic

• The tear is small to medium (1 – 3 cm) but still at risk 
  for re-tear due to other factors

 

What to do
If you are considering having rotator cuff surgery and you feel the use
of BioTend may be of value, contact your surgeon and discuss the
use of BioTend.

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Useful Links
American Academy of Orthopaedic Surgeons: http://www.aaos.org/
http://orthoinfo.aaos.org/topic.cfm?topic=A00064

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National Institutes of Health, National Institute of Arthritis and Musculoskeletal and
Skin Diseases (NIAMS):
http://www.niams.nih.gov/
http://www.niams.nih.gov/Health_Info/Shoulder_Problems/default.asp

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Wikipedia
http://en.wikipedia.org/wiki/Rotator_cuff