Prospective clinical study of a novel biodegradable sub-acromial spacer in treatment of massive irreparable rotator cuff tears* Vladimir Senekovic, Boris Poberaj, Ladislav Kovacic, Martin Mikek, Eliyahu Adar, Assaf Dekel.
A prospective study that was conducted to assess the safety and performance of the InSpace™ in subjects having Massive Rotator Cuff Tear (RCT) and scheduled for surgical intervention. The study was conducted in Slovenia .24 subjects, Mean age of 68.8 years, 12 male were implanted with the InSpace™ balloon.
- No device-related adverse effects.
- MRI (@3y PO) showedno significant findings, and no bone or cyst formation. 1 subject was suspected to have synovitis (had also a worsening of his Total Constant Score (TCS).
- 50% of the treated subjects (12/24) had an improvement of at least 10 points in their shoulder function (TCS) 6 weeks after implantation.
- The results indicate that the OrthoSpace InSpace™ system is a beneficial solution that can be safely and efficiently used for subjects with massive RCT that is considered irreparable.
Published on: Eur J Orthop Surg Traumatol DOI 10.1007/s00590-012-0981-4
This number increased throughout the 5-year post-implantation period as presented in the graph below:
Prospective Multi-Center Study of a Novel Biodegradable Inflatable Spacer to treat Massive Rotator Cuff Tears. (Short-term preliminary results).
Maman Eran, Eliyahu Adar, Dekel Assaf, Ori Safran , Shaul Beyth, Ofir Uri , Ofer Rak, Michael Berenstein, Mozes Gavriel
The study is an open-label, single-arm, multi-center prospective study. Patients with massive RCT underwent implantation with the InSpace™ spacer. Follow-up visits were scheduled according to routine clinical practice to assess safety and efficacy. Shoulder function was evaluated using the Total Constant Score (TCS).
- 47 patients with device implantation were included (23 male, mean age 69.7 years).
- Of these patients, 30 (46%) completed 1 year FU.
- At the 6-month follow-up, 68.8% (22/32) of the subjects showed at least 20 points of improvement in their TCS.
- Two device-related events (4%) occurred: One case of device displacement and one case of device removal due to deterioration in shoulder function.
CONCLUSIONS: The InSpace™ implantation in patients with massive RCT is apparently a low risk procedure, associated with low complications rate and resulting in improved shoulder function.
To the Technical article including Video @ Arthroscopy techniques by Dr Savarese