The MicroAire Sub-Acromial Shoulder Implant is a durable bladder that is filled with sterile saline. It fills the space between the acromion (a bony projection of the top of the shoulder blade) and the humerus (the upper arm bone). With a rotator cuff tear, the shoulder joint becomes unstable. Filling this space may improve joint stability and prevent painful bone-to-bone contact that can happen in an unstable joint.
Any surgery involves risk. Risks associated with the procedure are similar to the standard surgical repair of a rotator cuff and will be reviewed with you by the surgeon. Since the study device is investigational, there may be a risk of shoulder fracture and other risks that are unknown.
No. MicroAire Surgical Instruments (the sponsor of this study) will pay for all the costs associated with the study. You will need to continue covering the costs of other unassociated medical treatments you may be receiving, including medications.
Yes. As a condition of the study, you agree to return to the surgery clinic for evaluation periodically. Initial clinic visits occur 2 weeks, 6 weeks and 12 weeks (3 months) after surgery. Following that, return visits to the surgery clinic are every three months for the next two years.
There are other treatments for rotator cuff tears including physical therapy, surgical debridement, partial rotator cuff repair, and shoulder joint replacement. Alternatives for your condition may be discussed with your surgeon.
No. This implant is not resorbable by the body (it does not dissolve). It remains in the joint to fill the space between the acromion and the humerus.
The device is removable by means of an additional surgery. Although risks of the device are unknown, it is believed that patients would still be eligible for total shoulder arthroplasty (shoulder joint replacement).
If you meet all the criteria for enrollment and give consent to participate, you may be scheduled for surgery as soon as one week from enrollment. You must have the surgery no later than 45 days from your enrollment.
Participants are awarded a gift card for each clinic visit to help participants offset costs of transportation and time involved with participation.
No. All participants in this study will receive the device. All participants are informed that they have the device implanted in their shoulder joint.
For more information or to enroll,