PMID- 36946876
OWN - NLM
STAT- MEDLINE
DCOM- 20240103
LR  - 20240320
IS  - 1552-3365 (Electronic)
IS  - 0363-5465 (Linking)
VI  - 52
IP  - 1
DP  - 2024 Jan
TI  - 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.
PG  - 286-294
LID - 10.1177/03635465231155916 [doi]
AB  - BACKGROUND: Subacromial balloon spacers have been introduced as a potential 
      treatment option for patients with massive irreparable rotator cuff tears. 
      However, it is important to comprehensively assess the clinical efficacy of this 
      procedure in the context of an increasing amount of contemporary literature. 
      PURPOSE: To perform a systematic review of the contemporary literature to 
      understand the propensity for clinically meaningful improvements after 
      subacromial balloon spacer implantation for massive irreparable rotator cuff 
      tears. STUDY DESIGN: Systematic review and meta-analysis; Level of evidence, 4. 
      METHODS: The PubMed, Ovid/MEDLINE, and Cochrane databases were queried in July 
      2022 for data pertaining to studies reporting clinically significant outcomes 
      after subacromial balloon spacer implantation. Freeman-Tukey double arcsine 
      transformation was used to quantify the pooled rate of clinically meaningful 
      improvements in outcomes as evaluated using the minimal clinically important 
      difference (MCID), Patient Acceptable Symptom State (PASS), and substantial 
      clinical benefit (SCB). Qualitative analysis was performed when data were 
      variably presented to avoid misleading reporting. RESULTS: There were 10 studies 
      included, all of which reported MCID achievement. The overall pooled rate of MCID 
      achievement for the Constant-Murley score was 83% (95% CI, 71%-93%; range, 
      40%-98%), with 6 of 8 studies reporting rates equal to or exceeding 85%. One 
      study reported a 98% rate of PASS achievement for the Constant-Murley score at 
      3-year follow-up. The rate of MCID achievement for the American Shoulder and 
      Elbow Surgeons (ASES) score ranged between 83% and 87.5%. The rate of PASS 
      achievement for the ASES score was 56% at 2-year follow-up, while the rate of SCB 
      achievement for the ASES score was 83% and 82% at 1- and 2-year follow-up, 
      respectively. At 1-year follow-up, 74% and 78% of patients achieved the MCID for 
      the Numeric Rating Scale and Oxford Shoulder Score, respectively. At 3 years, 69% 
      of patients achieved the MCID for the Numeric Rating Scale and 87% achieved it 
      for the Oxford Shoulder Score. CONCLUSION: Patients who underwent isolated 
      subacromial balloon spacer implantation for massive irreparable rotator cuff 
      tears demonstrated a high rate of clinically significant improvement in outcomes 
      at short- to mid-term follow-up. A paucity of literature exists to appropriately 
      define and evaluate the rates of achieving the PASS and SCB after subacromial 
      balloon spacer implantation, necessitating further study.
FAU - Kunze, Kyle N
AU  - Kunze KN
AUID- ORCID: 0000-0002-0363-3482
AD  - Department of Orthopedic Surgery, Hospital for Special Surgery, New York, New 
      York, USA.
AD  - Sports Medicine Institute, Hospital for Special Surgery, New York, New York, USA.
FAU - Moran, Jay
AU  - Moran J
AUID- ORCID: 0000-0001-6247-3047
AD  - Yale School of Medicine, Yale University, New Haven, Connecticut, USA.
FAU - Cecere, Robert
AU  - Cecere R
AD  - Weill Medical College, Cornell University, New York, New York, USA.
FAU - Taylor, Samuel A
AU  - Taylor SA
AD  - Department of Orthopedic Surgery, Hospital for Special Surgery, New York, New 
      York, USA.
AD  - Sports Medicine Institute, Hospital for Special Surgery, New York, New York, USA.
FAU - Fu, Michael C
AU  - Fu MC
AD  - Department of Orthopedic Surgery, Hospital for Special Surgery, New York, New 
      York, USA.
AD  - Sports Medicine Institute, Hospital for Special Surgery, New York, New York, USA.
FAU - Warren, Russell F
AU  - Warren RF
AD  - Department of Orthopedic Surgery, Hospital for Special Surgery, New York, New 
      York, USA.
AD  - Sports Medicine Institute, Hospital for Special Surgery, New York, New York, USA.
FAU - Dines, David M
AU  - Dines DM
AD  - Department of Orthopedic Surgery, Hospital for Special Surgery, New York, New 
      York, USA.
AD  - Sports Medicine Institute, Hospital for Special Surgery, New York, New York, USA.
FAU - Gulotta, Lawrence V
AU  - Gulotta LV
AD  - Department of Orthopedic Surgery, Hospital for Special Surgery, New York, New 
      York, USA.
AD  - Sports Medicine Institute, Hospital for Special Surgery, New York, New York, USA.
FAU - Dines, Joshua S
AU  - Dines JS
AD  - Department of Orthopedic Surgery, Hospital for Special Surgery, New York, New 
      York, USA.
AD  - Sports Medicine Institute, Hospital for Special Surgery, New York, New York, USA.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Systematic Review
DEP - 20230322
PL  - United States
TA  - Am J Sports Med
JT  - The American journal of sports medicine
JID - 7609541
SB  - IM
CIN - Am J Sports Med. 2023 Oct;51(12):NP43-NP44. PMID: 37777866
MH  - Humans
MH  - *Rotator Cuff Injuries/surgery
MH  - Treatment Outcome
MH  - Arthroscopy/methods
OTO - NOTNLM
OT  - balloon spacer
OT  - irreparable
OT  - outcomes
OT  - rotator cuff tear
OT  - shoulder
OT  - subacromial
COIS- One or more of the authors has declared the following potential conflict of 
      interest or source of funding: S.A.T. has received consulting fees from DJ 
      Orthopedics, KCI USA, and DePuy Synthes and hospitality payments from Exactech. 
      M.C.F. has received consulting fees from Stryker and Encore Medical, support for 
      education from Smith & Nephew and Medwest Associates, and grants from Arthrex and 
      Acumed. R.F.W. has received royalties from OrthoBio Therapeutics, Arthrex, and 
      Zimmer Biomet. D.M.D. has received consulting fees from Zimmer, Merck Sharp & 
      Dohme, and Trice Medical; publishing royalties and financial support from Thieme; 
      other financial or material support from Biomet; and support for education from 
      Gotham Surgical Solutions & Devices. L.V.G. has received royalties from Exactech 
      and Zimmer Biomet; has received consulting fees from Biomet, DePuy Synthes, 
      Exactech, Medical Device Business Services, and Responsive Arthroscopy; has 
      received support for education from Gotham Surgical Solutions & Devices; has 
      received speaking fees from Smith & Nephew; and holds stock or stock options in 
      Imagen and Responsive Arthroscopy. J.S.D. has received royalties from Arthrex, 
      Linvatec, Zimmer Biomet, Thieme, and Wolters Kluwer Health-Lippincott Williams & 
      Wilkins; has received consulting fees and research support from Arthrex; has 
      received support for education from Gotham Surgical Solutions & Devices; and 
      holds stock or stock options in ViewFi. AOSSM checks author disclosures against 
      the Open Payments Database (OPD). AOSSM has not conducted an independent 
      investigation on the OPD and disclaims any liability or responsibility relating 
      thereto.
EDAT- 2023/03/23 06:00
MHDA- 2024/01/03 09:42
CRDT- 2023/03/22 10:34
PHST- 2024/01/03 09:42 [medline]
PHST- 2023/03/23 06:00 [pubmed]
PHST- 2023/03/22 10:34 [entrez]
AID - 10.1177/03635465231155916 [doi]
PST - ppublish
SO  - Am J Sports Med. 2024 Jan;52(1):286-294. doi: 10.1177/03635465231155916. Epub 
      2023 Mar 22.