SASI is a soft yet durable implant that does not dissolve. It is placed by arthroscopic surgery in the space between the top of the humerus (upper arm bone) and a bony projection of the shoulder blade directly above it (called the acromion).
Objectives of the study are to evaluate whether the device prevents undesirable bone contact, how the device is fixed in the shoulder joint, and the device’s fit. Additionally, the study will determine if it improves range of motion, reduces shoulder pain, and improves quality of life.
This study is sponsored by MicroAire® Surgical Instruments.
Participants will receive up to $650 in compensation for attending all follow-up appointments.
Participants (or their insurance companies) will not be expected to pay for any of the procedures, for the study device, or for tests that are part of this research study.
Participants will still need to pay for their usual medical care. This would include any non-study procedures and/or non-study medication that are needed while in the study.
1 | Consultations & Enrollment |
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2 | Outpatient Surgery: | Surgery performed at Valencia Surgical Center and must be within 45 days of enrollment. | ||||
Visit # | Time from Surgery | X-ray | MRI | Range of Motion Score | Quality of Life Survey | Pain Evaluation |
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3 | 2 weeks | |||||
4 | 6 weeks | |||||
5 | 12 weeks | |||||
6 | 6 months | |||||
7 | 9 months | |||||
8 | 12 months | |||||
9 | 15 months | |||||
10 | 18 months | |||||
11 | 21 months | |||||
12 | 24 months |
For more information or to enroll,
CAUTION: Investigational Device. Limited by Federal (or
IRB Approval #17637998.0
Southern California Orthopedic Institute
Principal Investigator: Ronald P. Karzel, MD
Contact: Marc Castillo, Research Coordinator
– email MaCastillo@scoi.com or call (818) 901-6600 ext. 1525