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Resumen: Introducción: Una de las patologías más frecuentemente atendida en nuestro medio son las lesiones tendinosas que afectan al manguito rotador del hombro. Existen diferentes modalidades de tratamiento para las roturas masivas o irreparables. Desde hace unos años, se introdujo en el mercado una técnica poco invasiva basada en la colocación de un espaciador subacromial biodegradable. El objetivo del trabajo es analizar los resultados de nuestra experiencia con el uso de este dispositivo (InSpace®). Material y método: En el estudio se recogen los resultados obtenidos en 25 pacientes con roturas irreparables del manguito rotador definidas mediante resonancia magnética (RM), en los que se les implantó un balón subacromial en nuestro centro en el periodo comprendido entre enero de 2015 hasta diciembre de 2017. Todos los pacientes fueron evaluados preoperatoriamente y un año después de la cirugía incluyendo la escala visual analógica (EVA), el test de Constant (CS) y el QuickDASH (QD). Resultados: De los 25 pacientes, cinco pacientes (20%) fueron intervenidos mediante artroscopia y 20 (80%) mediante abordaje abierto (mini-open). Un total de 22 pacientes completaron el año de seguimiento. A los 12 meses, el 64% (14/22) de los pacientes obtuvo una mejoría de al menos 10 puntos en el CS. Los pacientes partían de un CS promedio inicial de 32 puntos que mejoró hasta los 54,9 puntos de media en la evaluación postoperatoria a los 12 meses (Promedio de mejoría 22,9 puntos; p < 0,05). En cuanto a la evaluación del dolor, en nuestro estudio, el 87% (19/22) de los pacientes obtuvo una mejoría de al menos 2 puntos en la EVA a los 12 meses de seguimiento (p < 0,05). Los pacientes partían de una EVA media inicial de 8,7 que mejoró hasta los 3,7 puntos de media a los 12 meses. Un 73% de los pacientes contestaron estar satisfechos con la intervención y volverían a someterse a la cirugía. Conclusión: Los resultados obtenidos en nuestra serie a un año de seguimiento hablan en favor de la utilización del balón subacromial de tipo InSpace®, como opción terapéutica disponible para pacientes con roturas irreparables del manguito rotador. Puede ser utilizado como procedimiento provisional, retrasando la necesidad de una cirugía más invasiva, o definitivo en los pacientes médicamente no candidatos a una artroplastia inversa. Es importante tener claras las indicaciones de este procedimiento para no cometer errores. Abstract: Introduction: One of the most frequently treated pathologies in our department are tendon lesions that affect the rotator cuff of the shoulder. There are different types of treatment for massive or irreparable tears. For a few years, a low-invasive technique was introduced based on the placement of a biodegradable subacromial spacer. The objective of the work is to analyse the results of our experience with the use of this device (InSpaceTM). Material and method: The study collects the results obtained in 25 patients with irreparable ruptures of rotator cuff defined by RM, in which they were implanted a balloon subacromial in our centre in the period from January 2015 – until December 2017. All patients were evaluated preoperatively and one year after surgery including the visual analogue scale (VAS), the Constant test (CS) and the QuickDASH (QD). Results: Of the 25 patients, 5 patients (20%) were operated by arthroscopy and 20 (80%) By open approach (mini-open). A total of 22 patients completed the follow-up year. At 12 months, 64% of the patients obtained an improvement of at least 10 points in the CS. Patients departed from an initial average CS of 32 points that improved to 54.9 points of average in the postoperative evaluation at 12 months (average improvement 22.9 points; Value-p < 0.05). In terms of pain assessment, in our study, 87% of patients obtained an improvement of at least 2 points in the EVA at 12 months of follow-up (P-value < 0.05). Patients departed from an initial average EVA of 8.7 that improved to 3.7 points average at 12 months. 73% of the patients responded to be satisfied with the intervention and would return to the surgery. Conclusión: The results obtained in our series to one year of follow-up speak in favour of the use of the Subacromial Balloon (InSpaceTM), as a therapeutic option available for patients with irreparable ruptures of the rotator cuff. It can be used as an interim procedure, delaying the need for more invasive surgery, or as a definitive procedure in patients medically non-candidates for reverse arthroplasty. It is important to have clear indications of this procedure in order not to make mistakes.

Treatment of massive rotator cuff tears can be challenging, especially when tears are considered irreparable or, when repaired, at significant risk of retear. A surgical technique is described using a biodegradable subacromial balloon-shaped spacer (InSpace; Ortho-Space, Caesarea, Israel) that, when implanted between the humeral head and acromion, permits smooth, frictionless gliding, supporting shoulder biomechanics. The specific insertion technique described herein is a simple procedure that can be performed in a day-care or outpatient setting with patients under local anesthesia, thus providing a treatment option for patients with multiple comorbidities complicating or contraindicating surgery, such as reverse arthroplasty under general anesthesia.

The management of massive, irreparable rotator cuff tears (RCT) is challenging and associated with high failure rates. There are no current consensus or definitive guidelines concerning the optimal surgical treatment for this devastating condition. This study was designed to confirm the long-term safety and efficacy of the biodegradable inflatable InSpace™ system in patients with massive reparable or irreparable RCTs. In this open-label, single arm, prospective study, subjects with massive RCT underwent subacromial implantation with the biodegradable spacer. Follow-up visits were scheduled according to routine clinical practice. Shoulder function was evaluated using Total Constant Score (TCS). Twenty-four patients were treated and assessed. Four patients had partial tears, and in three of them RC repair was performed. These patients were not included in the efficacy analyses. Of the participating subjects who reached the 5-year follow-up, 84.6% of the patients showed a clinically significant improvement of at least 15 points in their score, while 61.54% showed at least 25 points of improvement. Only 10% of the treated patients showed no improvement or worsening in the shoulder score comparing to their baseline. An overall improvement in the total CS commencing at 3 months and sustained by 6 months through to 5 years of follow-up (P

Unsuccessful outcomes after repair of massive rotator cuff ruptures accompanied by muscle atrophy and fatty degeneration are frequently associated with inadequate management and secondary tears. We report the functional differences after rotator cuff rupture repair with a biodegradable spacer application. In these patients, rotator cuff rupture repair should provide coverage of the humeral head. Subsequently, acromioplasty should be performed to allow adequate space for the subacromial spacer. Thereafter measurement of the intra-articular space required for application of the biodegradable spacer is performed. Using this method can decrease the rate of tears by providing a safe subacromial space in cases of massive rotator cuff rupture.