Interventional procedure overview of biodegradable subacromial spacer insertion for rotator cuff tears.

[Moon AS, Harshadkumar A, Patel MD et al. (2019) Subacromial spacer implantation for the treatment of massive irreparable rotator cuff tears: A systematic review. Arthroscopy, Vol 35, No 2]

Systematic review

n=200 patients, 204 shoulders

mean 19.4 months follow up

Patients have satisfactory outcomes at 2-3 years follow-up with a low rate of complications after subacromial spacer implantation.

More recent systematic review included.

Stewart RK, Kaplin L, Parada SA et al. (2019) Outcomes of subacromial balloon spacer implantation for massive and irreparable rotator cuff tears. OJSM, 7(10).

Systematic review

N= 284 patients (291 shoulders).

Mean 22.9 months follow-up

Subacromial balloon spacer has favourable patient-reported outcomes at limited short-term follow-up.

More recent systematic review included.

Vecchini E, Gulmini M, Peluso A et al. The treatment of irreparable massive rotator cuff tears with inspace balloon: rational and medium-term results

Case series

N=79 patients

Mean follow-up 56 months.

Improvement in function and ROM following InSpace implantation.

Small case series

Gervasi E, Maman E et al. Fluoroscopically guided subacromial spacer implantation for massive rotator cuff tears.

Case series

N=46 patients

Follow-up 2 years

87.5% of patients saw statistically significant improvement in Constant and ASES scores.

Low rates of complications

Case series

Malahias M-A, Brilakis E et al. Satisfactory mid-term outcome of subacromial balloon spacer for the treatment of irreparable rotator cuff tears.

Case series

N=31

Mean follow-up 22.1 months

InSpace implanation leads to statistically significantly improved mid-term outcomes and high patient satisfaction

Small case series

Yallapragada RK, Apostolopoulos A et al. The use of a subacromial spacer-inspace balloon in managing patients with irreparable rotator cuff tears.

Non-randomised study.

N=14

Mean follow-up 12.6 months

Spacer implantation resulted in improved shoulder function and pain.

Small case series

Iban MAR, Moreno RL et al. The absorbable subacromial spacer for irreparable posterosuperior cuff tears has inconsistent results

Case series

N=16

Follow-up: 12 and 24 months

Outcomes after implantation of subacromial spacer at 2-year follow-up are not satisfactory. Only 40% of patients clearly benefit from surgery.

Small case series

Piekaar RSM, Bouman ICE et al. Early promising outcome following arthroscopic implantation of the subacromial balloon spacer for treating massive rotator cuff tear.

Case series

N=44 patients, 46 shoulders

Follow-up: 1 year

Biodegradable balloon spacer statistically significantly reduces pain and improves ADL at 1 year follow-up.

Included in systematic reviews already in overview

Ricci M, Vecchini E et al. A clinical and radiological study of biodegradable subacromial spacer in the treatment of massive irreparable rotator cuff tears

Case series

N=30

Follow-up: 3, 6, 12 and 24 months

Results support biodegradable spacer implantation for shoulder function improvement and reduction of pain.

Already included in systematic review within overview.

Basat HC, Kircil C et al. Treatment alternative for irreparable rotator cuff ruptures: Arthroscopic biodegradable balloon

Case series

N=12

Biodegradable balloon yields improvement in function, ROM and all patients were satisfied.

Small case series already included in systematic review in overview.

Gervasi E, Maman E et al. Fluroscopy-guided biodegradable spacer implantation using local anaesthesia: safety and efficacy study in patients with massive rotator cuff tears

Case series

N=15

Follow-up: 6 weeks and 12 months

All patients demonstrated an improvement in constant score and ASES.

Small case series, already included in systematic review within overview.

Kooistra B, Gurnani N et al. Low level of evidence for all treatment modalities for irreparable posterosuperior rotator cuff tears.

Systematic review

N=2000 (including all treatments for rotator cuff tears).

Minimum 2 years follow-up

The weighted mean improvement in constant score following subacromial spacer was 32.5.

More recent systematic review with the same studies included.

Moreno JG, Bellido PC et al. Results after the application of biodegradable spacer balloons as therapeutic option in non-repairable massive ruptures of the shoulder rotator cuff.

Case series

N=25

Follow-up: 1 year

Results are in favour of the use of subacromial balloon.

Small case series

Garofalo R, De Crescenzo AD et al. 2022. Rotator cuff repair protected with subacromial balloon spacer shows low rate of non-healing

Case series

N=32

Mean follow-up 27 months

Clinical outcomes and pain scores improved statistically significantly without severe complications.

Small case series

Familiari F, Nayar SK et al. 2021 Subacromial balloon spacer for massive, irreparable rotator cuff tears is associated with improved shoulder function and high patient satisfaction

Case series

N=51

Mean follow-up 36 months

At mean 3-years follow-up, subacromial spacer placement was associated with statistically significant improvement in shoulder function, limited need for revision surgery and high patient satisfaction.

Case series

Piekaar RSM, Bouman ICE et al. 2019. The subacromial balloon spacer for massive irreparable rotator cuff tears: approximately 3 years of prospective follow-up.

Case series

N=44 patients, 46 shoulders.

Follow-up: 3 years

Biodegradable balloon spacer leads to statistically significant reduction in pain and improvement of function.

Already included in systematic review included within overview.

Deranlot J, Herisson O et al. 2017. Arthroscopic subacromial spacer implantation in patients with massive irreparable rotator cuff tears: clinical and radiographic results of 39 retrospective cases

Case series

N=37 patients, 39 shoulders.

Follow-up: min 1 year

Biodegradable spacer implantation leads to statistically significant improvement in shoulder function at a minimum of 1 year postoperatively.

Case series already included in systematic review.

Senekovic V, Poberaj B. 2013. Prospective clinical study of a novel biodegradable subacromial spacer in treatment of massive irreparable rotator cuff tears.

Case series

N=20

Follow-up: 3 years

Biodegradable spacer is a low risk procedure associated with improvement in shoulder function and low complications

Case series already included within systematic reviews.

Hughes JD, Davis B et al. 2022. Nonarthroplasty options for massive, irreparable rotator cuff tears have improvement in ROM and patient-reported outcomes as short-term follow-up: a systematic review

Systematic review

N=3363 (assessing multiple options for treating rotator cuff tear).

Follow-up: minimum 1 year

All treatment options (including spacer insertion) resulted in statistically significant improvements in ROM and patient-reported outcomes.

Other systematic reviews selected instead.

Oderuth ENH, Morris DLJ et al. 2021. The balloon spacer improves outcomes in only a minority of patients with an irreparable rotator cuff tear.

Case series

N=22

Mean follow-up: 31.4 months

The balloon spacer is effective in a minority (32%) of patients in the medium term. The majority convert to reverse total shoulder replacement or remain symptomatic.

Small case series

Mease SJ, Wang KC et al. (2023) Tendon transfers, balloon spacers, and bursal acromial reconstruction for massive rotator cuff tears.

Review

N/A : discusses reasons for conflicting results in the 2 RCTs within overview.

No results.

Oh JH, Park, JH et al. (2019) Comparing clinical outcomes after subacromial spacer insertion versus other reconstruction methods in the treatment of irreparable massive rotator cuff tears

Cohort study

N=17 patients (spacer) versus 36 patients (other techniques)

Follow-up: Min 2 years

No difference in outcomes between subacromial spacer and other techniques, but other techniques have high retear rate.

Small number of patients treated with spacer.

Kunze KN, Moran J et al. (2023) High rate of clinically meaningful achievement in outcomes after subacromial balloon spacer implantation for massive irreparable rotator cuff tears: a systematic review and meta-analysis

Systematic review and meta-analysis

N=748 (of which 379 underwent subacromial balloon spacer implantation)

Follow-up: 1-3 years depending on outcome measure.

Patients who underwent isolated subacromial balloon spacer implantation for massive irreparable rotator cuff tears demonstrated a high rate of clinically significant improvement in Constant-Murley score, ASES and OSS.

Other systematic reviews included similar studies. This paper was published after literature search was completed.