OrthoSpace Ltd. (“OrthoSpace” or “the Company”) today announced that results from two studies evaluating the use of the InSpace™ biodegradable balloon spacer to treat massive, irreparable rotator cuff tears have been published in the journals Musculoskeletal Surgery and Acta Bio Medica. Massive, irreparable rotator cuff tears (RCTs) are associated with severe pain and disability, and patients with RCTs of this magnitude have historically had few treatment options.
The two publications reported the following results, respectively:
- In an independent, prospective, single-arm study, 44 patients (46 shoulders) with massive, irreparable RCTs were treated with the InSpace System. At one year of follow-up, patients reported a mean reduction in pain scores of 3.5 points (on a scale of 0 to 10), with 74% of patients achieving a difference of 2 points, which was considered the threshold for minimal clinical importance. Shoulder function, as measured by the Oxford shoulder score (OSS) and Constant–Murley shoulder score, improved significantly in this treatment cohort, and the authors noted that 80% of patients reported that they were satisfied with their outcome. Notably, this study also included a subset of 11 patients (24%) who were concurrently treated with a partial repair of the rotator cuff. The authors found no differences in outcomes of these patients in regard to pain or function compared to the patients who received InSpace alone. (Piekaar et al, 2017)
- In an independent, retrospective study of 30 patients with irreparable rotator cuff tears treated with the InSpace System, authors Ricci et al reported statistically significant increases in Constant Scores in a cohort of patients evaluated at 6 months (from 39.89 to 62.33 points) and in a separate cohort evaluated at 12 months (from 41.66 to 65.38 points) after surgery. Range of Movement and Activity of Daily Living measures significantly improved with the reduction of VAS and pain scores at 12 months. The authors reported a further increase in functional performance with the reduction of pain at 24 months post-operatively. Additionally, the authors analyzed X-ray and MR imaging to observe that all patients had a pre-operative acromiohumeral distance less than 6 mm and lesion grades of 3 to 4 according to the Goutallier classification, while, post-operatively, each case was observed to have an acromiohumeral distance of greater than 7 mm at all imaging timepoints. MRI also confirmed the complete degradation of the spacer in each patient by 24 months. (Ricci et al, 2017)
“We are pleased to see the publication of these positive results from Drs. Piekaar and Ricci and colleagues, which demonstrate the compelling benefit of InSpace to patients with massive rotator cuff tears,” said Itay Barnea, CEO of OrthoSpace. “We note in particular the promising outcomes from the addition of InSpace to partial repair of the tendon, which helps to demonstrate the versality of the InSpace System. These results add to the growing body of evidence favoring the use of InSpace as a novel, minimally invasive treatment for patients who have failed conservative therapy or otherwise have few options to treat painful, irreparable RCTs.”
The InSpace System is deployed in the subacromial space between the acromion and the humeral head, allowing smooth gliding and frictionless movement between the two bones and emulating the function of the original bursa. It is usually placed arthroscopically in a procedure that requires only 10 minutes to perform, and the balloon is believed to fully degrade within 12 to 24 months.
The InSpace System is CE Marked in Europe and Israel and is investigational in the U.S. and Canada, where it is currently being evaluated in a prospective, single-blinded, multi-center, randomized, controlled study that will enroll up to 184 patients.