Frequently Asked Questions

Indication

The InSpaceTM biodegradable balloon implant is used as a spacer to reduce friction between the acromion and the humeral head or rotator cuff. The indications for the InSpaceTM rotator cuff balloon include:

  • Scarred or torn tendons due to trauma or degradation.
  • Absence of tendon/muscle, or non-functional tendon/muscle.
  • Ruptured tendon.

Who can perform the procedure?

Orthopedic surgeons should be familiar with the procedures and techniques involving InSpaceTM Balloon placement in the subacromial space.

How long is the rehabilitation program?

Following the rational of minimal invasive procedure with no rotator-cuff repair, the expectation is to immediately begin the rehabilitation process. As every patient and case is slightly different, the surgeon in each case needs to make the determination regarding the extent of activity that is allowed at any given time.

Is the InSpaceTM balloon useful for shoulder osteoarthritis?

No! InSpaceTM has not yet studied this indication.

What clinical data is available?

InSpaceTM has already shown initial safety and efficacy in a double-arm, single center study in Slovenia,(Dr. Senkovich et.al , Esska 2010). Indicated for patients with chronic, massive rotator-cuff tears with failure following 12 months of conservative treatment.

Result were:

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| Disclaimer: The InSpaceTM balloon 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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