Answers to the most frequently asked questions
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.
IMPORTANT INFORMATION ABOUT INSPACE
The InSpace Implant is indicated for the treatment of patients with massive, irreparable full-thickness torn rotator cuff tendons due to trauma or degradation with mild to moderate gleno-humeral osteoarthritis in patients greater than or equal to 65 years of age whose clinical conditions would benefit from treatment with a shorter surgical time compared to partial rotator cuff repair.
The InSpace Implant is not appropriate for patients with certain types of infections, known or suspected allegories to the implant and/or instrument materials, or children.
The following information provided is based on data collected in the US Pivotal Clinical Study. There is evidence of increased risk of total adverse events of the affected shoulder compared to a partial rotator cuff repair, which were reported to be mostly mild to moderate in severity. Please note that complications reported by InSpace and Partial Repair patients were reviewed by a group of experts in shoulder surgery, and it was determined that none were related to the treatment devices (i.e., the InSpace Implant or devices used for Partial Repair). There is evidence of increased adverse events associated with a serious risk of the index shoulder which includes both medical and surgical treatments. The InSpace Implant is not fixed in place and may change position in the shoulder space. Movement out of the subacromial space and/or deflation of the InSpace Implant was observed in magnetic resonance imaging (MRI) 6 weeks post-operatively in up to half of patients. In these cases, it should be noted that no re-operations were required to remove the InSpace Implant.
The risks and benefits of the InSpace Implant in patients with the following conditions should be carefully considered: severe arthritis in the shoulder or full thickness cartilage loss, deltoid muscle defect or deltoid muscle paralysis, evidence that the shoulder is very unstable, missing or non-intact ligaments in the shoulder, known loss of sensation, major medical conditions such as blood clotting disorders, conditions that suppress the immune system or any other conditions that may compromise healing, safety and effectiveness of InSpace Implant use in patients below age sixty-five (65) has not been established, and safety and effectiveness of InSpace Implant use in pregnant or nursing mothers has not been evaluated.
If a reaction occurs, it will require follow-up with your surgeon. Some examples are as follows: irritation at the site where a cut was made during surgery, local infection, inflammation, and tissue damage where the InSpace Implant was implanted, or worsening of an existing infection. Additionally, movement of the implant out of its intended location may lead to worsening of your shoulder pain, discomfort, and/or stiffness which may require a re-operation, narcotic medications, non-narcotic pain medications, or post-operative shoulder injections.
As with any surgery, your surgical procedure may cause complications or adverse events. As with any shoulder surgery involving anesthesia there are potential risks and complications, including dizziness, fainting, difficulty breathing, wound infection, wound drainage, swelling, local pain, bleeding, bruising, surgical wound opening, nerve pain or injury which could result in partial or complete loss of movement in your affected arm, tendon injury, loss of sensation in your skin and muscle around your surgical site, inflammation of the tissues that surround your rotator cuff joint, a frozen rotator cuff (inability to freely move the shoulder joint) and delayed wound healing. There is a risk that a deep vein clot will form (thrombosis) and travel to the lung (pulmonary embolism), which could lead to stroke, heart damage or death. Any of the aforementioned complications/risks could require treatment such as medicine or additional surgery that may involve replacing or removing your InSpace Implant dependent on timeframe as the implant is biodegradable.
The information presented is for educational purposes only. Speak to your doctor to decide if you are interested in learning more about the InSpace Implant. Individual results vary and not all patients will receive the same postoperative activity level. It is important to follow your surgeon’s advice regarding after surgery care (for example, physical therapy) as well as which immediate activities you may or may not perform after receiving the InSpace Implant. Not following this advice may cause complications with the InSpace Implant. Some complications may require you to have additional surgery. Ask your doctor if the InSpace Implant is right for you.
Stryker Corporation or its other divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: InSpace, Stryker, Together with our customers, we are driven to make healthcare better. All other trademarks are trademarks of their respective owners or holders.
1000904124 Rev A