Table 4.
Design Characteristics of Each Clinical Study Included in this Systematic Review: Part 2
| Study | Measured Outcomes | Mean Follow-Up (Months ± SD) | Patients Lost to Follow-Up | Conclusions |
|---|---|---|---|---|
| Basat et al., 201726 | Constant score; Oxford Shoulder Score; VAS; abduction | 38.3 ± 8.03 | – | In patients in whom conservative treatment is insufficient for irreparable RTC tears, the biodegradable balloon has shown to improve mean constant score, mean Oxford Shoulder Score, and mean shoulder abduction degree. |
| Deranlot et al., 201738 | Flexion, abduction, external rotation; Constant score; acromiohumeral distance; Hamada classification | 32.8 ± 12.4 | – | Arthroscopic implantation of a subacromial spacer for irreparable RTC tears leads to significant improvement in mean Constant score and shoulder anterior elevation, abduction, and external rotation at a minimum of 1 year postoperatively. |
| Gervasi et al., 20167 | Constant score; ASES score, range of motion | 24 | 1/15 (6.66%) patients lost to follow-up at 6 months due to ref for RTSA (clinical condition not improving) and only 10/15 patients completed at least 2 years’ follow-up | Fluoroscopy-guided implantation of the InSpace system for management of MRTC tears results in an overall improvement in total Constant score and ASES score beginning at 6 wk postoperatively and sustained by at least 12 wk postoperatively. |
| Holschen et al., 201739 | Constant score, ASES score, subjective satisfaction | 30.6 for Group A, 22.3 for Group B | 2/23 (8.70%) patients lost to follow-up because of conversion to reverse total shoulder arthroplasty due to lack of improvement of symptoms | The ISB is a feasible treatment for patients with MRCT and compared to conventional treatment methods, the ISB results in greater absolute improvement in both ASES score and Constant score. |
| Malahias et al., 201940 | Constant score, ASES score, Flexion, abduction, external rotation, internal rotation, VAS score, patient satisfaction | 22.1 ± 9.8 | – | The use of ISB for patients suffering from MRCT leads to significantly improved ASES score, Constant score, and VAS pain scores. The use of arthroscopic partial repair with ISB was not superior to ISB implantation alone. |
| Maman et al., 201825 | Constant score | 12 | Only 43% (18/42) of patients were willing to return between 24-40 months postoperatively either due to logistical reasons or other non-shoulder comorbidities | Spacer implantation in patients with MRTC provides significant improvement in Constant score up to the 1-y follow-up visit. Additional long head of the biceps tenotomy did not influence the postoperative results. |
| Naggar 201841 | Constant score, UCLA | 52.5 | – | Arthroscopic implantation of an inflatable biodegradable balloon provides significant improvement in Constant score and UCLA score in patients with MIRCT. |
| Piekaar et al., 202042 | NRS for pain, Oxford Shoulder Score, Constant-Murley shoulder score (CMS), Satisfaction | 34 | 1 patient lost to follow-up due to chemotherapy, 1 patient died 2 mo postoperatively from cardiac disease, 2 patients with RTSA, and 1 patient received repeat arthroscopy | Arthroscopic implantation of the balloon spacer leads to sustained reduction in NRS pain score and Oxford Shoulder Score in patients with irreparable RTC tears during 3 years of follow-up. |
| Prat et al., 201843 | UCLA, Quick-DASH; flexion, external rotation, internal rotation, satisfaction, upward migration index (UMI) | 14.4 ± 15 | 2 patients lost to follow-up 3 mo after surgery (7.69%) | Subacromial balloon spacer placement for MIRCT led to improvements in UCLA score, but poor patient satisfaction rating and minimal improvement in proximal humeral head migration on postoperative radiographs. |
| Ricci et al., 201744 | Constant score, VAS score, subacromial space on AP radiographs | 9.8 | – | Placement of subacromial spacer resulted in sustained improvement in TCS, range of motion, and ADL performance while also providing pain relief at 24 mo follow-up in patients with MIRCT. |
| Ruiz Ibán et al., 201845 | Constant score, Quick Dash; flexion, external rotation, internal rotation, abduction, simple shoulder score | Median 24 | 1 patient lost to follow-up due to severe worsening of Parkinson disease | The use of the subacromial spacer does not seem to be a reasonable alternative to the management of the majority of patients with irreparable RTC tears because only 40% of the patients in this study experienced an improved Constant score at 24 mo. |
| Senekovic et al., 201746 | Constant score, range of motion, subjective pain score, relief of shoulder night pain, ultrasound evaluation | 60 | Dropout rate was 9/24 (37.5%) w/ 1 patient withdrawing at 6 weeks due to lack of improvement, 2 patients died due to non-ortho issues, 1 patient had RTSA at 4 years, and 5 other patients refused to come for follow-up | Implantation of the InSpace system in patients with MRCT refractory to conservative treatment is an effective alternative because it results in sustained improvement of total Constant score through 5 y of follow-up. |
| Yallapragada et al., 201847 | Constant score, Oxford Shoulder Score; flexion, abduction, external rotation | 12.6 | – | Implantation of a subacromial spacer or irreparable RCTs results in significantly improved mean Constant score, Oxford Shoulder Score, and range of motion through a mean of 12.6 mo follow-up. |
AP, anteroposterior; ASES Score, American Shoulder and Elbow Surgeons score; ISB, InSpace Balloon; MRCT, massive rotator cuff tear; NRS, numeric rating scale; Quick-DASH, Disabilities of the Arm, Shoulder, and Hand score; RCT, rotator cuff tears; RTC, rotator cuff; RTSA, reverse total shoulder arthroplasty; SD, standard deviation; VAS, visual analog scale.