2017 ISAKOS Biennial Congress ePoster #2239
Fluoroscopy Guided Biodegradable Spacer Implantation Using Local Anesthesia: Safety And Efficacy Study In Patients With Massive Rotator Cuff Tears
Enrico Gervasi, MD, Udine ITALY
Eran Maman, MD, Kiriyat Ono ISRAEL
Assaf Dekel, MD, Tel Aviv ISRAEL
Enrico Cautero, MD, Latisana, Udine ITALY
Department of Orthopaedic Surgery, Latisana Civil Hospital, Latisana, Udine, ITALY
The FDA has not cleared the following pharmaceuticals and/or medical device for the use described in this presentation. The following pharmaceuticals and/or medical device are being discussed for an off-label use:
Summary
The procedure of insertion of the InSpace under local anesthesia can be carried out in a day-care or outpatient setting; it is technically easy.
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Abstract
Background
The management of massive rotator cuff tears (MRCT) is challenging and associated with a high failure rates. Studies have shown that advanced age, lower American Society of Anesthesiologists (ASA) physical status score and concomitant co-morbidities are associated with higher risks of death and postoperative complications. This study was designed to assess the safety and efficacy of fluoroscopy guided biodegradable spacer implantation under local anesthesia, in patients with MRCT and comorbidities completely or partially contraindicating surgeries under general anesthesia.
Methods
In this open-label, single arm, prospective study, subjects with MRCTs underwent sub-acromial fluoroscopy guided implantation with a biodegradable spacer under local anesthesia. Follow-up visits were scheduled according to routine clinical practice. Shoulder function was evaluated using Constant (CS) and American Shoulder and Elbow Society (ASES) scores.
Results
Fifteen patients were treated and assessed. All patients demonstrated an overall improvement in the total CS and ASES beginning at 6 weeks and sustained by at least 12 months postoperatively. Of the 15 patients who reached the 1-year follow-up, 85 % of the patients showed a clinically significant improvement of at least 15 points in their Constant score starting at 6 weeks post operation and maintained throughout the entire follow up period.
Conclusions
We conclude that in this initial patient's cohort, fluoroscopy guided implantation of InSpaceTM system under local anesthesia, represented an effective alternative to the existing procedures. This procedure may be considered as a treatment option for elderly patients or for patients with multiple comorbidities complicating or contraindicating surgery under general anesthesia. Technically easy, this technique can be an effective tool in the armamentarium of most orthopedic surgeons.