Why was the InSpace™ balloon spacer developed?
The InSpace balloon spacer was designed as an additional surgical treatment option for patients 65 years of age and older with MIRCTs, whose clinical conditions would benefit from treatment with a shorter surgical time compared to other surgical treatment options. It was designed to restore the space between your upper arm bone (humerus bone) and the outer edge of your shoulder (acromion), and temporarily reduce rubbing between these bones. This helps to relieve pain associated with tendon tears and enables the bones in your shoulder to glide easily next to each other. InSpace is the only minimally invasive biodegradable, subacromial balloon spacer for arthroscopic treatment of MIRCTs.
How long has the InSpace™ balloon spacer been available to patients?
The InSpace balloon spacer received FDA clearance for use in the United States in July 2021. Since its FDA clearance, thousands of InSpace implants have been used in patients in the US with a similar shoulder problem as you. Outside of the US, InSpace has been implanted in over 38,000 procedures across 40 countries since 2010.
What does recovery look like?
Arthroscopic surgeries done in the outpatient setting allow for patients to return home the same day. Everyone recovers at a different pace and faces different issues. Age and overall health always play a role in recovery. After surgery, your shoulder will have a bandage over the small cuts to seal the area. In the days and weeks after surgery you will continue to wear a shoulder sling according to your surgeon’s guidance. Some patients experience little pain and some may have pain for a few weeks after surgery. If there is pain, it is expected to decrease over time. In addition, your surgeon may limit the weight and activity placed on your shoulder for the first week or two after surgery. Your surgeon will monitor your healing over the following weeks after surgery and will let you know when you may return to normal daily activities. Be sure to ask your surgeon about any heavy lifting, pushing or pulling as these activities may be restricted. Speak with your surgeon if you have any questions about performing any activities not mentioned.
How long is the typical length of hospital stay after InSpace surgery?
Usually, you are not admitted into hospital and your surgery is done as an out-patient procedure with no overnight stay.
Are my activities restricted after InSpace surgery?
Yes. During the days and weeks after surgery you will continue to wear a shoulder sling according to your surgeon’s guidance. Your surgeon will continue to monitor your progress over the following months and will let you know when you may return to your normal daily activities.
When can I return to my normal daily activities?
At your surgeon’s recommendation, you can return to your normal daily activities. Be sure to ask your surgeon about any heavy lifting, pushing or pulling as these activities may be restricted. Speak with your surgeon if you have any questions about activities not mentioned.
When can I return to work?
Before returning to work, review your job description and what your employer may do to minimize chances of injury to your shoulder. This may include being able to rest, at times. If you perform physical work, you may return to work once your surgeon approves this activity.
How long until I can drive?
Before returning to driving, make sure that you have the approval of your surgeon.
What happens should I ever need an X-ray or MRI, or need to pass through a metal detector?
There is no metal in your InSpace implant therefore an X-ray, MRI or metal detectors will not be affected.
How long will it take the InSpace implant to be reabsorbed by my body?
The InSpace™ Implant will biodegrade or reabsorb over time in your body, with full resorption expected after approximately one year.
Has the implant material used in the InSpace implant been used in other medical devices?
Yes. The material used in the InSpace implant has also been used in many other ways in the body in implanted medical devices for many years.
Why was a clinical study required for the InSpace implant?
Because InSpace is a new and unique device, a clinical study was required by the FDA (Food and Drug Administration) before the device could be offered to a patient in the US. FDA clearance of the InSpace implant was given after review of the results of a clinical study designed to assess the safety and effectiveness of the InSpace implant against the standard of care, Partial Repair (PR) for arthroscopic surgical treatment of a full thickness MRCT. This study is referred to as the US Pivotal Clinical Study.