Shoulder Function After Rotator Cuff Repair
Frequently Asked Questions (FAQs)
What is the purpose of this study?
A rotator cuff tear is a common and painful condition that is often repaired surgically, but some rotator cuff repairs fail and shoulder function after surgery is sometimes unpredictable. Recent research suggests that repair tension (i.e. the force required by the surgeon to pull a torn rotator cuff tendon back into place during the repair surgery) and repair tissue elongation (i.e. how much the repaired tissue elongates during shoulder motion) may provide insight into post-operative healing and shoulder function. Therefore, this study will determine how rotator cuff repair affects shoulder motion, strength, and patient-reported outcomes, and how repair tension and repair tissue elongation influence these outcomes. The proposed research is relevant to public health because it will advance our understanding of the treatment of rotator cuff tears and will ultimately lead to improved patient care and lower medical costs.
How much time will participating in this study take?
If you choose to participate in this study, you will make a total of 5 visits to the Department of Orthopaedic Surgery's Motion Analysis Laboratory. The first visit will be prior to your surgery and the last visit will be 2 years after your surgery. We will need you to visit the lab about a week after your surgery, but that visit will not require you to do any shoulder motion or strength testing. With the exception of the 1 week post-surgery visit, each visit will take approximately 90 minutes.
What data will you collect on me?
We will collect you shoulder motion using a special x-ray system. Additionally, we will collect information regarding your shoulder pain (e.g. severity, duration), function, and physical activity. We will also perform strength testing to see how strong your shoulder is. We will also obtain a shoulder MRI 1 year after your rotator cuff surgery to monitor its healing.
Will I be exposed to radiation in this study?
Yes. For this study, you will be exposed to radiation through X-rays and one CT scan. However, the amount of radiation you will be exposed to over the course of the study has not been shown to cause harmful effects in adults.
Will I be paid to participate in this study?
Yes, you will be paid a total of $250 for participation in the study according to the following schedule:
Will I have to pay for parking?
Yes and no. When you visit the Motion Analysis Laboratory before and after surgery, your parking will be free. However, you will have to pay for parking when you get your post-surgical MRI 2 years after your surgery at Henry Ford Hospital.
Why do you need to put a bead in my shoulder?
The purpose of placing the bead in your shoulder is to allow us to track the healing of your rotator cuff tendon over time. The bead will be attached to your supraspinatus tendon which, as you regain motion, will show us how the tendon is functioning.
What is the bead made of? Is it safe?
The bead that would be implanted is made of tantalum. Tantalum is a bio-compatible material, meaning it is safe to use in the human body. As a result, it is used in various types of orthopedic implants and for other medical purposes. Tantalum beads are commonly used in research studies such as this one because of these properties as well as it appearing clearly on medical imaging.
Will I notice the bead under my skin?
No. The bead is very small (3 mm) and would be attached to the tendon part of your supraspinatus muscle. The attachment will be under the bony area of your shoulder. Therefore, it is unlikely that the bead would be visible under your skin, or that you would even notice it there.
Will I be okay to get an MRI with the bead in my shoulder?
Yes. The bead is non-ferrous (contains no iron) and is therefore non-magnetic. As a result, it does not impact your ability to safely get MRIs.
Can I still participate in the study without getting the bead implanted?
No. Unfortunately, we would be unable to do the study without the bead being implanted in your shoulder.
Will I be able to learn about the results of the study?
Yes! If you are interested in finding out what we learned from this study, you can sign up to receive a lay language summary which we will share after the conclusion of the study. You can also sign up for the Bone and Joint Center’s quarterly newsletter to learn more about ongoing studies and our research findings.
Who is funding this study?
This study is funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which is part of the National Institutes of Health (NIH). Therefore, this study is funded by taxpayers through the federal government.
Do the researchers involved in the study receive any financial incentives for conducting the study?
No. The researchers and study staff do not receive financial incentives for conducting the research.