Studies indicate that Stryker's InSpace implant may be a viable treatment option for patients with massive irreparable rotator cuff tears (MIRCTs).
The biodegradable InSpace implant is designed to restore the subacromial space, providing a less invasive solution vs. other surgical treatment options that require fixation devices or grafts. InSpace has been demonstrated to improve shoulder motion and function.
The comparative study evaluated the efficacy and safety of InSpace with arthroscopic partial repair in patients with irreparable, posterosuperior MIRCTs.
Results of the two-year study demonstrated the InSpace implant as an appropriate alternative to partial repair in patients with MIRCTs. The study also revealed notable patient benefits, including early functional recovery and pain relief combined with a shorter operative time.
InSpace, acquired from OrthoSpace in 2019, received FDA 510(k) marketing clearance in 2021. Earlier this year, CMS established a new Healthcare Common Procedure Coding System code C9781 for outpatient hospitals and ambulatory surgery centers to report the insertion of the InSpace balloon implant.