These promising results continue to validate the ability of InSpace to provide a long-term, less-invasive, lower-risk surgical solution for patients living with the pain and disability associated with massive rotator cuff tears.
CAESAREA, Israel (PRWEB) January 04, 2017
OrthoSpace Ltd. (“OrthoSpace” or “the Company”) today announced the publication of long-term follow-up data for patients enrolled in an open-label, single-arm, prospective study evaluating the use of the InSpace System for the treatment of massive rotator cuff tears (RCTs). The study, published in the Archives of Orthopaedic and Trauma Surgery, reported that a cohort of 20 patients with irreparable, full-thickness RCTs showed improvements in shoulder function and subjective pain scores starting at six weeks of follow-up, with these gains maintained at up to five years.
“Massive rotator cuff tears represent a painful condition that can severely limit everyday activity. For patients who don’t respond to conservative therapy, there are currently no consensus guidelines for a preferred surgical option,” said Vladimir Senekovic, M.D., an orthopedic surgeon at the University Medical Centre in Ljubljana, Slovenia and the principal investigator of the study. “InSpace offers a less-invasive, low-risk and effective treatment option for patients living with this challenging condition. Our results with the system demonstrate long-term, sustained improvements in pain and shoulder function.”
The InSpace System consists of a biodegradable balloon spacer that is usually implanted arthroscopically. The device was rated technically easy to use by surgeons participating in this study and can be implanted in just 10 minutes. It represents a novel surgical option for the treatment of RCTs, a complex indication where existing surgical options are often associated with high failure rates.
This study enrolled patients with persistent pain and functional disability for at least six months, imaging conﬁrmation of an RCT by ultrasound, CT or MRI and documented failure of conservative therapy. Primary endpoints included improvements in shoulder function, as measured by the Constant score (CS), subjective pain scores (SPS), range of motion (ROM) and activity of daily living (ADL), as well as the rate of postoperative complications.
An evaluation of the overall change in total CS from baseline showed that 18/20 patients (90%) had some improvement in their scores at one or more of the follow-up visits. Statistically signiﬁcant improvement was noted in total CS at six months, which was sustained for up to five years of follow-up. Of patients participating in the ﬁnal follow-up visit, 84.6% showed a clinically signiﬁcant improvement of at least 15 points in their CS, while 61.5% showed at least 25 points of improvement. Patient-reported pain scores, ADL and ROM improved by a mean of 96%, 122% and 64%, respectively, from baseline. There were no complications or unexpected device-related adverse events recorded during this study.
“These promising results continue to validate the ability of InSpace to provide a long-term, less-invasive, lower-risk surgical solution for patients living with the pain and disability associated with massive rotator cuff tears,” said Itay Barnea, CEO of OrthoSpace. “Over 10,000 patients have been treated with the InSpace System since our European product launch in 2011, and we look forward to continuing to develop clinical research in support of the system and remain committed to improving outcomes for patients with this debilitating condition.”
About OrthoSpace Ltd.
OrthoSpace is a privately held medical device company located in Caesarea, Israel. The Company's product, InSpace, is an orthopedic biodegradable balloon system that is simple, safe and a minimally invasive method that addresses unmet clinical needs in rotator cuff repair. InSpace is CE Marked and commercialized in Europe and Israel and has been granted an Investigational Device Exemption (IDE) to initiate a pivotal human clinical study of the InSpace System in the United States.