Purpose
To assess the mid-term clinical outcomes of percutaneous balloon spacer insertion in patients older than 60 years with rotator cuff arthropathy under regional anesthesia and fluoroscopic guidance.
Methods
A retrospective study was conducted. Patients older than 60 years with rotator cuff arthropathy, an American Society of Anesthesiologists (ASA) score of 3 or 4, and undergoing balloon spacer insertion under fluoroscopic guidance were included. Patients with previous rotator cuff repair/arthroscopic surgery or who did not have a trial of physical therapy prior to surgery were excluded. Range of motion, visual analog scale (VAS), Single Assessment Numeric Evaluation, and American Shoulder & Elbow Surgeons score were collected at baseline, 2 weeks, 6 months, and a minimum of 1 year postoperatively.
Results
Seven operated shoulders (6 patients) were included in this study. The mean age was 78.1 years (range, 68-90 years). There were 5 ASA 3 patients (83%) and 1 ASA 4 patient (17%). At 2 weeks postoperation, there was significant improvement in the VAS score, from a mean (SD) of 7.7 (1.6) to 4.8 (2.6) ( P =.003). At 6 months postoperation, there was significant and sustained improvement in the VAS score, with a mean (SD) of 3 (3.2) ( P =.020). At a minimum of 1 year postoperatively (range 12-48 months), there was significant improvement, with a mean (SD) of 2.9 (3.0) ( P =.012) in the VAS score and 67 (21) ( P =.025) in the Single Assessment Numeric Evaluation score. The American Shoulder & Elbow Surgeons score improved from a mean (SD) of 44.7 (13) to 64.3 (26.5) at final follow-up but was not statistically significant. Range of motion did not significantly improve at all time points.
Conclusions
Percutaneous insertion of a subacromial balloon spacer results in a significant reduction of pain in patients aged 60 years and older with rotator cuff arthropathy but does not improve their function at a minimum 1-year follow-up.
Level of Evidence
Level IV, retrospective therapeutic case series.
There is an increased prevalence of degenerative rotator cuff tears in the aging population. Patients can often present after a prolonged period of symptoms with irreparable rotator cuff tears and rotator cuff arthropathy. Surgical techniques such as partial repair, superior capsular reconstruction, tendon transfers, or shoulder arthroplasty can be employed for such tears. ,, However, these techniques can be technically challenging and require relatively higher surgical skill and operating time. As such, these procedures may be unsuitable in the older, low-demand patient with significant medical comorbidities.
In such patients presenting with irreparable rotator cuff tears or rotator cuff arthropathy, pain is often the chief complaint. Tuberoplasty, bursal acromial resurfacing, and balloon spacers are alternative procedures for pain relief. ,, The mechanism of the balloon spacer is well established—it exerts a spacer effect in the acromiohumeral interval so as to reduce pain due to superior migration of the humeral head in massive rotator cuff tears. The balloon spacer was initially designed to treat massive irreparable rotator cuff tears in patients with pain but preserved function. Several studies have shown positive results for pain reduction in this group of patients. ,,,, However, it is difficult to delineate the isolated effect of the balloon spacer as associated procedures are often performed during arthroscopic insertion of the balloon spacer. Verma et al. published a multicenter randomized controlled trial that found that balloon spacer insertion had noninferior outcomes as compared to partial repair for massive rotator cuff tears at a 24-month follow-up. It was subsequently highlighted that a mean of 3.4 concomitant procedures were performed in the balloon group, making direct comparison challenging. It is clear that further literature is required to determine the effects of balloon spacer insertion alone.
The purpose of this study was to assess the mid-term clinical outcomes of percutaneous balloon spacer insertion in patients older than 60 years with rotator cuff arthropathy under regional anesthesia and fluoroscopic guidance. We hypothesized that percutaneous insertion of a subacromial balloon spacer would result in a significant reduction of pain in patients older than 60 years but would not improve their function.
Methods
A retrospective review was performed. Institutional ethics approval (2024/00237) was obtained. All patients who underwent isolated balloon spacer insertion under regional anesthesia and fluoroscopic guidance in a single center from 2018 to 2023 were reviewed. Two surgeons performed all of the surgeries (S.W.L.H., L.T.J.T.). The inclusion criteria included patients aged 60 to 100 years with rotator cuff arthropathy who had an American Society of Anesthesiologists (ASA) score of 3 or 4 and a previous trial of nonoperative treatment with physical therapy and/or corticosteroid injection. Patients with previous rotator cuff repair/arthroscopic surgery or who did not have a trial of physical therapy prior to surgery were excluded. Baseline data, including age, sex, medical comorbidities, and ASA score, were documented. The degree of rotator cuff arthropathy was assessed on plain radiography (anteroposterior view) via the Hamada classification. Range of motion of the affected shoulder in flexion, external rotation with hand by the side, and internal rotation (level of vertebral body) was assessed. Patient-reported outcomes such as the visual analog scale (VAS), Single Assessment Numeric Evaluation (SANE), and American Shoulder & Elbow Surgeons (ASES) score were collected at baseline, 2 weeks, 6 months, and at final follow-up (minimum of 1 year postoperation). In accordance with published literature, the following minimal clinically important difference (MCID) values were used: ASES (27.1), SANE (14.9), and VAS (2.4).
Surgical Technique
An interscalene anesthetic block is performed prior to surgery. Patients are placed in a beach-chair position. The operated shoulder is cleaned and prepared with the arm draped free. The fluoroscopy is positioned over the shoulder. Fluoroscopy is performed to ensure that an anteroposterior view is achieved and also to determine the preoperative acromiohumeral Index. A single “50-yard line” lateral incision is made and expanded with artery forceps. A switching stick is placed into the subacromial space and advanced until it reaches the glenoid edge. This is visualized on fluoroscopy and represents the medial limit of the balloon spacer ( Fig 1 ). A second switching stick is used to determine the length between the medial limit and the edge of the greater tuberosity, which is the lateral limit of the spacer balloon position. Once this distance is obtained, it is marked onto the spacer balloon cannula so that the depth of insertion is known. The spacer balloon cannula is inserted via the lateral portal to the predesignated depth. Once the depth has been reached, the balloon is deployed and inflated with the appropriate saline volume. On fluoroscopy, there should be an increase in the acromiohumeral Index. The balloon is then detached from the cannula and the incision is closed.
(A) Right shoulder, beach-chair position. Anteroposterior fluoroscopic view: Switching stick is inserted from the lateral portal to define the medial edge of balloon spacer positioning. (B) Right shoulder, beach-chair position. Anteroposterior fluoroscopic view: The spacer balloon cannula (∗) is inserted into the subacromial space. The cannula is partially opaque on fluoroscopy. (C) Right shoulder, beach-chair position. Anteroposterior fluoroscopic view: The balloon is inflated with the predesignated volume of normal saline, which then expands the acromiohumeral interval distance.
Rehabilitation
All patients underwent a standardized rehabilitation protocol. The operated shoulder was immobilized in an arm sling for 1 week postsurgery. Thereafter, active physical therapy was initiated with an emphasis on improving range of motion. There was no limitation to the range of motion allowed. Strengthening was started only when patients regained at least the preoperative range of motion.
Statistical Analysis
Categorical variables were presented as numbers and percentages. Values of continuous variables were presented as mean ± standard deviation (SD). The paired samples t test was used as appropriate to analyze the VAS, SANE, and ASES scores between different time points. A 2-tailed P value of less than.05 was considered significant for all tests. All statistical analyses were conducted using STATA v17 (StataCorp).
Results
Seven operated shoulders (6 patients) were included in this study. There were no excluded patients, and all patients completed a minimum 1-year follow-up. A single patient underwent the same procedure on the contralateral shoulder 2 years later. There were 3 women (50%) and 3 men (50%). The mean (SD) age was 78.1 (6.7) years (range, 68-90 years). Each patient had multiple medical comorbidities ( Table 1 ), with 5 ASA 3 patients (83%) and 1 ASA 4 patient (17%). All patients had evidence of rotator cuff arthropathy on plain radiography. At 2 weeks postoperation, there was significant improvement in the VAS score from baseline, with a mean (SD) of 7.7 (1.6) to 4.8 (2.6) ( P =.003). There was also improvement in the SANE score, from a mean (SD) of 40 (14) to 60 (22), although this was not statistically significant. At 6 months postoperatively, there was significant and sustained improvement in the VAS, with a mean (SD) of 3 (3.2) ( P =.020) ( Fig 2 ). At a minimum of 1 year postoperatively (range, 12-48 months), there was significant improvement, with a mean (SD) of 2.9 (3.0) ( P =.012) for the VAS score and 67 (21) for the SANE score ( P =.025) ( Fig 3 ). While the ASES score had improved from a mean (SD) of 44.7 (13) to 64.3 (26.5) at final follow-up, this was not statistically significant ( P =.10) ( Table 2 ). There was no significant increase in the range of motion of the shoulder in flexion, external rotation, or internal rotation at all time points. In terms of satisfaction, all but 1 patient were satisfied with their outcome at final review. There were no complications or reoperations in all patients.
Table 1
Baseline Characteristics
| Age, y | Sex | Comorbidities | ASA Score | Hamada Classification | Preoperative | ||||
|---|---|---|---|---|---|---|---|---|---|
| Forward Flexion | External Rotation | Internal Rotation | External Rotation Lag Sign | Belly-Press Test | |||||
| 75 | F |
|
3 | 3 | 40 | 40 | T10 | Positive | Negative |
| 76 | M |
|
4 | 3 | 20 | 0 | T12 | Positive | Positive |
| 68 | F |
|
3 | 4 | 160 | 40 | Buttock | Negative | Negative |
| 78 | F |
|
3 | 4 | 90 | 0 | T12 | Positive | Positive |
| 82 | M |
|
3 | 3 | 140 | 70 | L5 | Negative | Positive |
| 78 | M |
|
4 | 1 | 50 | 20 | L5 | Negative | Positive |
| 90 | M |
|
3 | 3 | 90 | 30 | T12 | Negative | Negative |
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