Table 3.
Design Characteristics of Each Clinical Study Included in this Systematic Review: Part 1
| Study | LOE | n | Adjustment for Confounding Variables | Experimental Group(s) Interventions | Control Group Interventions |
|---|---|---|---|---|---|
| Basat et al., 201726 | P (IV) | 12 | Inclusion: MIRCT (Patte > stage 3, Goutallier state 3 or 4, acromiohumeral distance <7 mm), complete disruption of supraspinatus and infraspinatus, presence of functional deltoid, age >60 y, failure of conservative treatment >6 mo. Exclusion: rotator cuff arthropathy, repairable RCT during MRI or arthroscopy, shoulder infection, neurologic deficit in shoulder muscles | Balloon spacer placement, subacromial debridement +/– biceps tenotomy (if biceps tendon intact) | |
| Deranlot et al., 201738 | R (IV) | 39 | Inclusion: MIRCT (Patte > stage 2, Goutallier > or = stage 3, no OA), Ffailure of conservative treatment >6 mo, minimum 1-year f/u. Exclusion: CTA > stage 3 Hamada class, subscapularis tear, intraoperative ability to repair tendon. Statistical analysis: CA was adjusted for age and sex, subgroup analysis (post hoc) was performed to identify differences based on the status of the long head biceps tendon (spontaneous preoperative rupture of biceps tendon didn’t influence postop acromiohumeral distance or constant score) | Balloon spacer placement, Subacromial debridement +/– biceps tenotomy (if biceps tendon intact) | |
| Gervasi et al., 20167 | P (IV) | 15 | Inclusion: MIRCT, age >50 y, failure of conservative therapy >4 mo. Exclusion: significant OA, GH instability, major joint trauma, infection, necrosis in shoulder. Statistical analysis: Adjusted CS and their subscales were determined using a repeated measures analysis variance model | Fluoroscopic-guided balloon spacer placement | |
| Holschen et al., 201739 | R (III) | 23 (11 in Group A, 12 in Group B) | Inclusion: MRCT, painful loss of shoulder function. Exclusion: no arthritis, no cranial migration of humeral head > type II Hamada, cuff tear arthropathy | Balloon spacer placement with subacromial debridement or partial repair +/– biceps tenotomy (if biceps tendon intact) | RTC debridement, synovectomy, bursectomy, biceps tenotomy/tenodesis, and partial reconstruction/repair of rotator cuff if possible |
| Malahias et al., 201940 | R (IV) | 31 (18 in Group A and 13 in Group B) | Inclusion: >50 y old, symptomatic MRCT, intraoperatively found to have irreparable (not able to perform complete repair) tears. Exclusion: <50 y old, no preoperative TCS scores, pseudoparalysis, small/medium RCTs, irreparable subscapularis tears, previous shoulder surgery on same side, open/mini-open repair, GH arthritis, rheum arthritis, psych disease, active shoulder infection, “uncontrolled hormonal disorders,: coagulopathy. Statistical analysis: no significant differences were found between ISB w/partial repair vs ISB alone and no significant differences in baseline demographics or clinical characteristics | Group A: Partial repair, balloon spacer placement, subacromial debridement, biceps tenotomy; Group B: balloon spacer placement, subacromial debridement, biceps tenotomy | |
| Maman et al., 201825 | P (IV) | 42 (21 in Group A and 21 in Group B) | Inclusion: functional disability/pain >4 mo, imaging confirmation of RCT, failure of conservative therapy. Exclusion: significant shoulder OA, GH instability, active shoulder infection, previous shoulder surgery, uncontrolled diabetes, immunosuppression, coagulopathy. Statistical analysis: mean changes from baseline in total CS and adjusted CS and subscales were determined using repeated measures analysis variance model (no significant difference between spacer placement with or without tenotomy) | Group A: balloon spacer placement, biceps tenotomy (unless tendon already completely ruptured), and subacromial debridement; Group B: balloon spacer placement and subacromial debridement | |
| Naggar 201841 | P (IV) | 22 | – | Balloon spacer placement | |
| Piekaar et al., 202042 | P (IV) | 39 (31 in Group A and 8 in Group B) | Inclusion: shoulder pain due to MIRCT on imaging and arthroscopy, failure of conservative management or failure of previous surgery, >18 y old. Exclusion: severe GH OA, rupture of subscapularis muscle, previous participation in research study of affected shoulder, allergy to device materials, active shoulder infection. Statistical analysis: CMS was adjusted for age and sex. | Group A: Arthroscopic bursectomy and decompression with balloon spacer placement +/– biceps tenotomy (only if biceps tendon intact); Group B: arthroscopic bursectomy and decompression, partial RTC repair, balloon spacer placement +/– biceps tenotomy (only if biceps tendon intact) | |
| Prat et al., 201843 | R (IV) | 24 | Inclusion: failure of conservative management; exclusion: inflammatory arthropathy, GH OA | Balloon spacer placement, Subacromial debridement +/– biceps tenotomy (if biceps tendon intact) | |
| Ricci et al., 201744 | R (IV) | 30 | Inclusion: Goutallier stage 3 or 4, Persistent pain for >6 mo, failure of conservative treatment. Exclusion: GH OA, GH instability, previous shoulder surgery, shoulder infection | Balloon spacer placement, subacromial bursectomy, biceps tenotomy, acromioplasty | |
| Ruiz Ibán et al., 201845 | P (IV) | 15 | Inclusion: MIRCTs on MRI, >50 y old, persistent pain/disability for >6 mo w/ >3 mo failed conservative therapy, Goutallier stages 3 or 4, Irreparability confirmed on arthroscopy, No cuff tear arthropathy, No GH OA. Statistical analysis: Post hoc analysis performed between preoperative situation (age, degenerative arthropathy, Constant score, active or passive ROM, pseudoparalysis) of the 6 subjects that had clinically relevant improvement and the 9 subjects that did not fare well | Balloon spacer placement, subacromial debridement +/– biceps tenotomy (if biceps tendon intact) | |
| Senekovic et al., 201746 | P (IV) | 24 | Inclusion: persistent pain/functional disability >6 mo, imaging confirmation of RCT, failure of conservative therapy, confirmation of irreparability and fatty infiltration on arthroscopy. Exclusion: GH OA, GH instability, active shoulder infection, previous shoulder surgery, DM, immunosuppression, coagulopathy. Statistical analysis: adjusted CS and its subscales were determined using a repeated measures analysis variance model (subgroup analysis revealed there were no statistical differences between clinical outcomes of subjects who went device implantation alone vs those who had any level of tendon repair, but those patients who had repair were NOT included in clinical efficacy assessment results). | Balloon spacer placement +/– biceps tenotomy, partial repair was performed in 3 patients | |
| Yallapragada et al., 201847 | P (IV) | 14 | Inclusion: MIRCT, failed conservative management >6 mo, muscle retraction (Patte > stage 2), muscle atrophy, fatty infiltration (Goutallier stage 3). Exclusion: GH OA Hamada grade 3, no preserved passive ROM, active infection, or allergies to the balloon material | Balloon spacer placement, subacromial debridement, biceps tenotomy in 9 patients |
CMS, Constant-Murley shoulder score; CS, Constant score; CTA, cuff tear arthropathy; DM, diabetes mellitus; f/u, follow-up; GH, glenohumeral; ISB, InSpace Balloon; LOE, level of evidence; MIRCT, massive irreparable rotator cuff tear; MRCT, massive rotator cuff tear; MRI, magnetic resonance imaging; OA, osteoarthritis; P, prospective; R, retrospective; RCT, rotator cuff tear; ROM, range of motion; RTC, rotator cuff; TCS, Total Constant Score.