34 Subacromial Balloon Spacer for Irreparable Cuff Tears

J. Gabriel Horneff III and Joseph A. Abboud

Summary

The massive irreparable rotator cuff repair is a difficult problem to treat in patients who are not suitable candidates for reverse shoulder arthroplasty. The subacromial balloon spacer is a newer technique designed to restore the relationship of the humeral head to the glenoid and allow patients to achieve improved function despite loss of their rotator cuff. This technique is relatively quick and easy to perform and affords patients the ability to regain functional use of their shoulder without jeopardizing the chance for any further surgeries in the future. The device is approved for use in the European Union and has undergone a Food and Drug Administration trial in the United States with promising results.

Keywords: balloon arthroplasty, irreparable cuff tear, massive cuff tear, proximal migration, subacromial spacer

34.1 Patient Positioning

? The patient is placed in the beach chair position. This allows for gravitational distraction of the humeral head and a more accurate depiction of the amount of subacromial space available without traction.

? The operative extremity is prepped and draped in the typical sterile fashion.

? A mechanical arm holder can be utilized to position the operative extremity in space.

34.2 Portal Placement

? A standard posterosuperior arthroscopic portal is initially created for placement of the arthroscope. This portal is utilized for the initial diagnostic arthroscopy of the glenohumeral joint and subacromial space.

? A lateral portal in line with the posterior border of the clavicle is created under spinal needle localization with arthroscope visualizing from the posterior portal. This portal is initially utilized for the debridement and decompression instruments prior to balloon insertion. Prior to balloon insertion, the lateral portal is utilized as the visualization portal for the remainder of the case.

? Alternative portal: an anterior portal just above the superior border of the subscapularis can be created under spinal needle localization if initial intraarticular pathology needs to be addressed prior to balloon implantation.

34.3 Surgical Technique (Step-by-Step Approach)

? Prior to incision, a surgical timeout should always be performed to correctly identify the patient, procedure, and correct operative limb (? Video 34.1).

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Video 34.1 Description of the balloon with arthroscopic placement.

? A standard posterior portal is created and the arthroscope is introduced into the glenohumeral joint. A diagnostic arthroscopy is performed to assess the rotator cuff, labrum, articular surface, and remaining structures.

? If the subscapularis tendon is torn, this should be repaired as best as possible by the surgeon?s preferred technique.

? Once all intraarticular work is completed, the arthroscope should be redirected to the subacromial space.

? A lateral portal is created under spinal needle localization in line with the posterior border of the clavicle.

? A combination of arthroscopic shavers, burs, and electrocautery are used via the lateral portal to remove any debris from the undersurface of the acromion. Any large subacromial spurs can be smoothed to allow for unimpeded placement/inflation of the balloon.

? Once visualization is adequate, a calibrated probe is used to measure the defect left behind from the deficient rotator cuff tissue. This measurement is performed in the anterior-to-posterior plane (rotator interval to intact posterior cuff) as well as the medial-to-lateral plane (superior glenoid rim to greater tuberosity).

? The InSpace balloon (OrthoSpace, Caesarea, Israel) is available in three sizes: small (40 mm � 50 mm), medium (50 mm � 60 mm), and large (60 mm � 70 mm).

? Once the defect is measured, an arthroscopic switching stick is placed laterally to allow for placement of the arthroscope into the lateral portal in the subacromial space.

? Select an appropriately sized balloon and prepare it on the back table to ensure an efficient placement.

? A syringe is filled with sterile saline warmed to roughly 40 �C. Attach this syringe to the extension tubing. Ensure that there is no air within the syringe or tubing.

? Introduce the balloon insertion device into the posterior portal and position over the superior glenoid rim.

? Once the balloon is in the proper position, retract the protection sheath to expose the balloon.

? Attach the extension tubing to the insertion handle and advance the plunger of the syringe to fill the balloon under visualization. Refer to the balloon size reference guide for the proper volume of saline to be injected.

? When filling of the balloon is complete, deploy the red safety button and turn the green knob on the insertion handle to seal the balloon as the handle is removed.

? With the balloon in place, take the patient?s shoulder through a range of motion to visualize that the balloon is stable without subluxation.

? Remove all instrumentation from the shoulder and close the portal sites with a nonabsorbable suture and dress with sterile dressings to preference.

? The patient is placed in a regular sling prior to awakening from anesthesia and then taken to the recovery room.

34.4 Surgeon Tips and Tricks

? One of the most important keys to success with interpositional balloon arthroplasty is proper patient selection. The following are criteria that we use to select patients:

? Functioning deltoid muscle.

? No history of infection.

? No significant glenohumeral arthritis.

? Intact or repairable subscapularis and posterior rotator cuff.

? Ability to actively forward elevate to at least 90� prior to surgery.

? Perform a thorough subacromial bursectomy using an arthroscopic shaver and electrocautery. It is important to achieve hemostasis with electrocautery to maintain a good visual field for deployment of the balloon.

? Avoid an aggressive bursectomy medial to the face of the glenoid as this can lead to medial migration of the balloon and decrease its depressing force effect on the humeral head.

? We find the long head of the biceps tendon to be a pain generator in the shoulder and prefer either biceps tenodesis or tenotomy prior to balloon insertion.

? Be sure to take careful and thorough measurements with the probe to select the appropriate balloon size. If visualization for sizing is difficult with the arthroscope in the posterior portal, use a switching stick to place the arthroscope into the lateral portal to allow for a better perspective when measuring.

? We have found that placement of the balloon via the posterior portal with lateral visualization allows for more accurate placement of the balloon. This is in contrast to the manufacturer?s recommendation of visualizing from the posterior portal and placing the balloon laterally.

? Avoid overinflation of the balloon as this can lead to rupture or possible subluxation of the device.

? Motion of the patient?s arm with the arthroscope visualizing the inserted balloon is essential to ensure that there is no subluxation or displacement of the device.

34.5 Pitfalls/Complications

? Aside from the usual possible risks that come with arthroscopic shoulder surgery (i.e., infection, bleeding, wound healing, etc.), we have found minimal risks with the use of this device.

? The largest concern with the use of this device is the possible migration of balloon from out of the subacromial space. In our experience, this has happened only one time and was resolved with removal and replacement of the balloon.

? In the literature, four studies from Europe have had a combined 93 patients who have undergone the balloon arthroplasty procedure. Only one patient of those combined cohorts had a dislocation of the device.

? No other device-related complication has been reported in the literature.

? As the availability of this device becomes more widespread, the most concerning pitfall with its use is improper patient selection. We think it is important that patients retain active functional ability to raise their arms to at least 90� of elevation. This device should not be used for patients with true shoulder pseudoparalysis.

? The InSpace balloon is CE marked in Europe and available for use in the patient with a rotator cuff tear that is otherwise unfixable. Currently, in the United States, there is a Food and Drug Administration investigational device exemption (IDE) trial that randomized patients to either balloon placement or the best attempted rotator cuff repair, required at least 90 degrees of active forward elevation and no signs of glenohumeral arthritis.

34.6 Rehabilitation

? Weeks 0 to 4: Sling use for comfort. Patient is allowed to use the arm for light activity (eating, hygiene, writing, typing). Patient encouraged to move hand, wrist, and elbow to prevent joint stiffness.

? Weeks 4 to 8: Discontinuation of the sling. Patient can return to activities of daily living. Formal physical therapy (PT) is started with a concurrent home exercise program. The patient?s PT begins with phase I and II stretching and early strengthening for up to 3 pounds.

? Weeks 8 to 12: The physical therapy regimen is advanced to full strengthening with transition to a home-based program. Strengthening can advance to 10?15 pounds.

? Weeks 12 and beyond: All restrictions are lifted and the patient can resume full activity.

34.7 Rationale and/or Evidence for Approach

? Patients with large irreparable rotator cuff tears develop proximal humeral migration as the compromised function of the torn cuff allows the deltoid muscle to create a superiorly directed shearing force at the glenohumeral interface.

? The biomechanical purpose of the subacromial balloon is to depress the humeral head and reduce subacromial friction for improved elevation and abduction.

? The first study published on this technique was by Senekovic et al in 2013 with 20 patients demonstrating improved Constant scores and range of motion as early as 6 weeks following their surgery. These improvements continued during the 3-year period of the study. Subjective pain and night pain also improved over the 3-year study period starting as early as 1 week out from surgery.1

? A follow up prospective study at 5 years for 21 patients for the InSpace technique found that 84.6% had a clinical improvement of at least 15 points with regard to Constant scores. In addition, 61.5% of those patients had at least 25 points of improvement. Scores improved as early as 3 months after surgery and lasted for 5 years.2

? Looking at all patients from published studies demonstrated only one device-related complication, which was a dislocation of the balloon that required replacement. The operative times for these same patients ranged from 2 to 30 minutes at an average time of 10 minutes.1,2,3,4

References

[1] Senekovic V, Poberaj B, Kovacic L, Mikek M, Adar E, Dekel A. Prospective clinical study of a novel biodegradable sub-acromial spacer in treatment of massive irreparable rotator cuff tears. Eur J Orthop Surg Traumatol. 2013; 23(3):311?316

[2] Senekovic V, Poberaj B, Kovacic L, et al. The biodegradable spacer as a novel treatment modality for massive rotator cuff tears: a prospective study with 5-year follow-up. Arch Orthop Trauma Surg. 2017; 137(1):95?103

[3] Deranlot J, Herisson O, Nourissat G, et al. Arthroscopic subacromial spacer implantation in patients with massive irreparable rotator cuff tears: Clinical and radiographic results in 39 retrospective cases. Arthroscopy. 2017; 33(9):1639?1644

[4] Gervasi E, Maman E, Dekel A, Cautero E. Fluoroscopy-guided biodegradable spacer implantation using local anesthesia: safety and efficacy study in patients with massive rotator cuff tears. Musculoskelet Surg. 2016; 100 Suppl 1:19?24