Massive rotator cuff tears are a challenging problem for treatment. The best results we can still achieve with reconstruction. For treatment of massive rotator cuff tears when reconstruction is not possible, a new method has been developed recently: the implantation of the biodegradable balloon spacer/InSpace™ balloon/filled with the saline in the subacromial space. The main characteristic of this method is that to allow gliding of the humeral head against acromion without friction and to depress the humeral head for 2–3 mm. This depression is just enough that the humerus is in a better center of rotation that allows the deltoid muscle more strength—better vector forces for the deltoid muscle. This function of the balloon permits better deltoid activation and compensation through the arc of motion. Results of our first study and results of others show clinical safety and efficacy of the insertion of the InSpace™ balloon in a group of patients with massive irreparable rotator cuff tears. The insertion of this device shows significantly better early improvement, significant improvement in subjective pain scores, and a decrease in reported night pain. The measurement of the Total Constant score showed statistically significant improvement after insertion of the InSpace™ balloon at 5 years of follow-up. Generally, all studies show 75–80% of good results.
- massive rotator cuff tear
- subacromial balloon spacer
The InSpace ™ system is a biodegradable balloon that is made for arthroscopic insertion into the subacromial space following bursa excision. The pre-shaped balloon is produced from a copolymer of poly-L-lactide-co-ε-caprolactone in a 70: 30 ratio, which biodegrades over a period of 12 months. The insertion of this balloon into the subacromial space is a low-risk procedure [6, 7, 8, 9]. The aim of this is mainly to allow gliding of the humeral head against acromion without friction and to depress the humeral head for 2–3 mm. This depression is just enough that the humerus is in a better center of rotation that allows the deltoid muscle more strength—better vector forces for the deltoid muscle. This function of the balloon permits better deltoid activation and compensation through the arc of motion (Figure 1) .
2. Preoperative assessment
2.1 Clinical assessment
Pain can limit the range of motion. The range of motion is usually limited under 90° of anteflexion and abduction .
Atrophy of the m. supraspinatus and m. infraspinatus is usually visible .
2.2 Imaging assessment
Anteroposterior and lateral views detect possible superior migration of the humeral head and osteoarthritic joint .
2.2.2 Ultra sound (US)
US is useful for detecting the tear and size of the tear.
We can see calcium depots and muscle atrophy .
3. Timing for surgery
The mean duration of symptoms because of the RCT prior to surgery has to be at least 3 months at patients over 60 years of age with documented failure of conservative treatment. All younger, we operate earlier [7, 21, 23].
At operation we always try to mobilize the cuff and make reconstruction or partial reconstruction. If this is not possible, then we decide on the implantation of the balloon .
4. Surgical preparation
4.1 Surgical equipment
4.2 Equipment positioning
4.3 Patient positioning
5. Surgical technique
We perform all shoulder operations with the patient in a beach-chair position.
We use three standard arthroscopic ports (anterior, lateral, posterior, or posterolateral).
At surgery we remove first partially the subacromial bursa (Figure 3), then we debride the tear and release the tendon. After this, we try to draw the edge of the tendons with an arthroscopic clamp to the footprint region (Figure 4). A decision is made to insert the balloon when it is obvious that the RCT is irreparable [6, 7, 30].
Then we choose the balloon size (small, medium or large) according to measurements.
Insertion of the proper balloon is aided by folding it into a cylindrical shape inside an insertion tube (Figure 6).
Once positioned in the subacromial space, the balloon is inflated with saline permitting frictionless gliding of the humeral head against the acromion. For each size we have to fill with the proper amount of the saline—it is written on the package (Figures 7,8) [6, 7].
Then we simply turn around the green ring on the handle holder and cut of insertion device from the balloon.
After this we can move the arm and suture the ports.
6. Postoperative course
6.1 Postoperative regime
The insertion of this device shows significantly better early improvement, significant improvement in subjective pain scores, and a decrease in reported night pain. The measurement of the Total Constant score showed statistically significant improvement after insertion of the InSpace™ balloon at 5 years of follow-up. Generally, all studies show 75–80% of good results. (Figure 9) [6, 11, 12, 13].
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