Abstract
Objectives:
While short and mid-term clinical outcomes following implantation of an arthroscopic subacromial balloon spacer for massive, irreparable rotator cuff tears (MIRCTs) have been favorable [1], little is known about the effects of concomitant procedures on clinical outcomes and early post- operative recovery. The purpose of this study was to determine the effects of concomitant proximal biceps surgery on short and mid-term outcomes following partial rotator cuff repair or subacromial balloon spacer implantation using the InSpace? device (Stryker; Kalamazoo, MI; Figure 1).
Methods:
We conducted a retrospective review of prospectively collected data from a previously published randomized, clinical trial comparing the InSpace? device to partial rotator cuff repair in the management of symptomatic MIRCTs (ClinicalTrials.gov Identifier: NCT02493660) [1]. Study participants with posterosuperior MIRCTs (as defined by MRI diagnosis of ≥2 tendon involvement and ≥5 cm of retraction from the tendon insertion) treated operatively with subacromial balloon spacer implantation or partial rotator cuff repair and concomitant biceps tenotomy or tenodesis were considered for this study. The primary outcome in this study was the achievement of minimal clinically important difference (MCID) and substantial clinical benefit (SCB) for the American Shoulder and Elbow (ASES) score at 6 weeks and 24 months postoperatively. Established MCID and SCB thresholds from the literature were used, requiring a ≥11.1-point increase in ASES score for MCID achievement and a ≥17.5-point increase for SCB achievement [2]. Fisher’s exact test was used to compare MCID and SCB achievement rates between groups.
Results:
A total of 103 patients were included in this analysis, of which 48 patients were in the InSpace? cohort and 55 were in the partial rotator cuff repair cohort (Table 1). At 6 weeks post-operatively, a larger percentage of patients who received InSpace? with concomitant biceps tenotomy achieved MCID on ASES compared to those receiving a concomitant tenodesis, though this result was not statistically significant (64.3% vs 42.1%, p = 0.15) (Table 1). Similarly, a larger percentage of patients who underwent arthroscopic partial rotator cuff repair with biceps tenotomy achieved MCID on ASES compared to those undergoing partial repair with biceps tenodesis, though this was not statistically significant (56.3% vs 40.9%, p = 0.41). Similar trends were seen for SCB achievement rates at 6 weeks (Table 2). Notably, SCB achievement rates were significantly greater for patients undergoing InSpace? with biceps tenotomy versus partial repair with biceps tenodesis (p = 0.04).
At 24 months, ASES MCID achievement rates for the InSpace? with biceps tenotomy group were similar to the InSpace? with biceps tenodesis group (96.2% vs 86.7%, p = 0.54) (Table 1). Similarly, there was no significant difference between the partial repair with concomitant tenodesis and tenotomy groups (100% vs 92.9%, p = 0.51). Similar trends were seen for SCB achievement rates at this time point (Table 2). Notably, there was no longer a significant difference in SCB achievement rates between the InSpace? with biceps tenotomy group and partial repair with biceps tenodesis group (p = 1.00).
Conclusions:
The primary goal of treatment during arthroscopic implantation of a subacromial balloon spacer is pain relief in the setting of relatively well-maintained function. Although all patients in this study received standardized post-operative rehabilitation, including 4-week sling use, our results suggest that providers seeking accelerated rehabilitation for their patients may consider concomitant biceps tenotomy for biceps pathology to avoid prolonged immobilization, decrease risk of stiffness, and provide earlier achievement of clinically significant outcomes on patient-reported outcome measures.
