Frequently Asked Questions

What are the balloon materials?
The InSpace™ balloon is made of a common biodegradable material (PLA and ε-caprolactone) – a polymer, which is a widely used material in the medical industry.
What is the InSpace™ Balloon mechanism of action?
The shoulder is a complicated joint that requires the interconnected functioning of tendons, ligaments and bones. When the InSpace balloon is implanted between the acromion and the humeral head, a space is created, keeping the humeral head centered and allowing smooth and frictionless gliding.
How long is the rehabilitation program?
Following the shoulder surgery, the affected shoulder will be immobilized and may be fitted with a sling. Physical therapy will be prescribed at the discretion of the doctor. These are the same procedures used for any shoulder surgery.
What are the risks and possible discomforts from being in this research study?
As with any shoulder surgery involving anesthesia there are potential risks and complications. The standard risks and complications of surgery are outlined in the surgical consent form you will review with your physician prior to your surgery.
The potential medical risks associated with implantation of the InSpace device in the shoulder are unknown, but are expected to include the usual risks for standard shoulder surgery. There may be a risk of prolonged surgical time due to device breakage or malfunction. Local tissue response to the implant or significant device movement from initial placement may also occur, in this case your doctor will decide whether to remove the device by surgery or leave in place till it has completely dissolved.
Your surgeon is experienced in this type of surgery, but the results of this surgery cannot be guaranteed. It is possible that the surgery will not reduce the pain or disability felt before surgery. In addition, the pain or disability may be worse after the surgery. There is some element of this risk in all surgeries, whether or not you receive the investigational device. If the treatment fails, standard surgical and non-surgical options will be discussed and planned with your surgeon.
What are the possible benefits of participating in the InSpace™ clinical study?
If you choose to participate in the study, the benefits of full thickness massive rotator cuff tear surgery may include reduction in pain and a potential for increase in function. If you choose to participate in the study, your shoulder may or may not heal more quickly. The information collected in this study to determine the safety and effectiveness of this new investigational device may benefit future subjects undergoing shoulder surgery. You may not benefit directly from participating in this study.
What other treatments or procedures are available for my condition?
You do not have to take part in this study to be treated for full-thickness, massive rotator cuff tear. If you choose not to participate in this study, there are other treatments available to you. These include physical therapy, surgical debridement of the joint, partial rotator cuff repair, or replacement of the shoulder joint. Similar risks may apply to those alternative procedures as they involve relatively similar surgical techniques, and some of these procedures may involve additional risks and precautions due to the nature of these procedures. Your surgeon will have additional information on each of these alternative treatments.
What are the costs associated with participating in the InSpace™ clinical study?
Study funds will pay for certain study-related items and services. Costs which are not associated with standard treatment, such as costs of the investigational device and MRI required specifically for this clinical research study, will be paid for by the OrthoSpace, Ltd.
Study participants will be responsible for payment of any deductibles and co-payments required by the insurer for routine care or other billed care.
Will I be financially compensated for participating in the InSpace™ clinical study?
Study participants will be compensated for completed study visits. This compensation is for the time and any travel expenses associated with participation in this study. Method of reimbursement will be determined at each study site.
How does the InSpace™ clinical study operate?
All study participants will be asked to review and sign a consent form. There will be routine tests and procedures performed as for any rotator cuff surgery, including magnetic resonance imaging (MRI) and a physical examination.
In addition to the normal and standard care, study questions will be asked prior to surgery about medical history and the shoulder to be treated. Study questions will be asked about shoulder pain, disability and function, general health and about any current medications (prescription or over-the-counter). The questionnaires will require about 20 minutes of time to complete.
This is a blinded study which means that study participants will not know which treatment (InSpace or Partial Repair) they have received until the study is closed.
How do I know if I am eligible for the InSpace™ clinical study?
All patients diagnosed with a full thickness massive rotator cuff tear will be assessed for study eligibility. Eligibility for study participation is determined based on strict inclusion and exclusion criteria. The doctor will determine eligibility.
What are the time commitments required to participate in the InSpace™ clinical study?
It will take approximately 24 months following shoulder surgery to complete this research study. During the 24 months following surgery, participants are asked to return for follow-up at 10 days after surgery, 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery (6 visits total).
Where can I get more detailed information about the InSpace™ clinical study?
A description of this clinical study will be available on www.ClinicalTrials.gov. Federal law in the U.S. requires clinical study information for this type of clinical study to be submitted to this data bank. This website will not include information that can identify participants. At most, the website will include a summary of the results. You can search this website at any time.

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Disclaimer: Investigational Device. Limited by US law to investigational use

Aug 2, 2016 | Posted by | Comments Off on FAQ
Disclaimer: The InSpace™ system is approved for marketing in Europe but is not approved yet for marketing in the USA. This material should be considered informational only and does not constitute an offer to sell in any jurisdiction in which this product is not yet permitted to be sold.
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