Restore™ Orthobiologic Implants for Use in Rotator Cuff Shoulder Surgery

The Restore™ implant is the first of its kind to be introduced in the worldwide orthopaedic market and has changed the treatment of soft tissue tears and damage.  

Traditionally, the treatment for reinforcing lost or damaged tissue has been bone or tissue transplants, but the Restore implant gives the surgeon a less invasive treatment when the rotator cuff tissue is of poor quality or the repair needs reinforcement.

Developed through a partnership between Purdue University and DePuy Orthopaedics, Inc. and introduced in 1999, the Restore implant provides surgeons with an absorbable brace to strengthen soft tissue repair.

While your body regenerates damaged tissues, the Restore implant reinforces the repaired soft tissue and provides a framework around which your body builds new tissue. As new tissue grows, the Restore implant slowly dissolves until all that remains is your tissue. The 10-layer thick implant is strong yet appears very thin and can easily be cut into shape to fit the needs of each particular surgery.

The Restore implant is derived from the submucosa lining of a pig's small intestine that has been cleansed, processed, and sterilized. Before being introduced, the Restore implant was extensively tested for safety. Careful safeguards have been implemented to eliminate the likelihood of infection or disease transmission.

However, you should be aware that reaction or rejection of the material could occur, particularly if you have a history of multiple or severe allergies, an overly sensitized immune system, or if you have a sensitivity to pork products. You may experience an allergic reaction resulting in redness, swelling, tenderness, and drainage at the site two to five days after surgery. Be mindful that some redness, swelling, pain and firmness at the surgical site are normal to the healing and remodeling of your tissue. But, never hesitate to call your surgeon should you have any questions or concerns.

Keep in mind that soft tissue repair is a surgery, and with any surgery, there may be general adverse effects or complications. These include:

• Infection
• Injury to nerves and blood vessels
• Fractures
• Weakness
• Stiffness or instability of the joint
• Pain
• Inability to repair a tendon
• Re-rupture
• General risks associated with surgery and anesthesia

There are also a few related risks associated with the Restore implant:

• Stretching or tearing of the implant
• Stiffness
• Chronic inflammation or swelling
• Longer rehabilitation period
• Failure of the implant to be replaced by natural tissue
• Immunological reaction

Finally, not all rotator cuff tears are repairable. If there is severe degeneration of the muscles and tendons of the shoulder, a complete shoulder replacement may be advised by the doctor.

Warning and Precautions

There is evidence that the potential for deep sepsis following implantation of devices may be reduced by the use of prophylactic antibiotics. It is important to discover and treat other pathologies in the affected soft tissue that may affect the patient's ability to return to activity. Strict adherence to the surgeon’s recommended postoperative management program is recommended.

Potential Tissue Response in Early Post-Operative Period

When using the Restore Orthobiologic implant for repair of soft tissue, the device is expected to significantly impact the wound healing response. Remodeling toward native tissue, as opposed to formation of scar tissue, is observed when Restore is used to facilitate and reinforce the repair of injured musculoskeletal tissues. As part of this remodeling sequence, the surgeon can and should expect to see signs of active proliferation of responding cells and of blood vessels at the repair site approximately two to four weeks post-operatively. Sometimes, this cellular response may be manifested in the following ways:

There may be localized redness and swelling that is moderately firm, and it may or may not be warm to the touch depending upon the degree of new blood vessel formation (angiogenesis) and blood vessel dilation. The amount of pain is patient dependent, as it is with most surgeries, and is in part related to the amount and location of the soft tissue swelling.

If the patient undergoes this anglo-fibrous proliferative response, the surgeon can expect to see it in the second to fourth week post surgery. Within four to six weeks post-operatively, the response resolves and the subsequent clinical course is generally uneventful as tissue remodeling subsides and the patient returns to normal activity. These symptoms should not be mistaken for an infection.

Potential Adverse Effects

The following are the most frequent adverse events following encountered in soft tissue repair: infection; adhesions; sterile effusion; instability; increased stiffness postoperatively; and general risks associated with surgery and anesthesia such as neurological, cardiac and respiratory deficit. Potential device related risks are: stretching or tearing of the device; stiffness; chronic synovitis or effusion; prolonged postoperative rehabilitation; delayed or failed incorporation of the device; immunologic reaction.

Last Updated: 08/29/2008