This document summarizes the results and experience of a study comparing the InSpace Balloon procedure to rotator cuff repair for massive rotator cuff tears. The interim analysis of the first 20 subjects in the randomized controlled trial showed no difference in outcomes between the two procedures at 6 months follow-up. The study is ongoing and being conducted by principal investigators across the United States to further compare the efficacy of InSpace Balloon versus repair for massive rotator cuff tears.

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Any darn fool can make
something complex;
It takes a genius to make
something simple.
- Albert Einstein

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InSpace Balloon
Our Results & Experience
Wrightington Upper Limb Unit
Lennard Funk
Mike Walton, Puneet Monga
Maria Moffatt

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Disclaimer
• Study supported by OrthoSpace

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Size does Matter!
• Tear Size is strongest predictor of failure:
• Independent of:
• Age
• Tissue Quality
• Time to Surgery
• Cho & Rhee. Clin Orth Surg. 2009
• Le, Lam, Murrell. AJSM. 2014

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History
• InSpace Originally intended and marketed as an
alternative to repair of Massive Cuff Tears
• Why?
• High failure rates of repair
• Long recovery period
• Costly
• Complications • Brislin, Field, Savoie. Arthroscopy. 2007

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InSpace Balloon
• Biodegradable PLLA copolymer
• Three sizes
• Filled with saline
• Starts to degrade at 2-3 months
• Fully disintegrated by 12 months
• Bozkurt M, Akkaya M, Gursoy S et al. Arthrosc Tech. 2005
• Holschen M, Brand F, Agneskirchner JD.Obere Extremität. 2016
• Reduces subacromial friction
• Extends the subacromial space
• Keeps humeral head centred
during dynamic movement

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History
• First case series intended as a safety & efficacy study - Massive
Irreparable Cuff Tears
• Very low complication rate
• Good Results
• = humeroplasty, biceps tenotomy, etc.
• = Partial cuff repair series
• But not as good as results of Reverse Arthroplasty
• Jost, Pfirrmann, Gerber. JBJS. 2000
• Green A. JAAOS. 2003
• Dines DM, Moynihan DP, Dines JS, McCann P. JBJS. 2006
• Neri BR, Chan KW, Kwon YK. JSES. 2009
• Bedi A, Dines J, Warren RF, Dines DM. JBJS. 2010

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So for MRCT:
InSpace Balloon:
• Quicker
• Easier
• Cheaper
• Safer
• Faster Recovery
Repair / Recon:
• Expensive
• Complex
• Long recovery
• Complications
• High failure
VALUE

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RCT: InSpace vs Repair for MRCT
• Randomized, Two Arm, Subject Blind
• Inclusion: >40yr, MRCT (>5cm)
• Exclusion: Major Trauma, Arthritis, Irreparable, Revision
• Outcomes: ASES, DASH, Constant, EQ-5D-5L,
• 6wks, 3m, 6m, 1yr (MRI), 2yrs
• Primary Efficacy: 10 point change
• Interim Analysis 20 subjects with 6m follow-up
ClinicalTrials.gov: NCT02208440; REC ref: 13/NW/0754; Protocol: IS-CL-02-UK; IRAS: 122315

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RCT: InSpace vs Repair for MRCT
• RESULTS (Jan 2017):
• 24 subjects:
• 14 with 6m data = 9 Balloon & 5 Repair
• 1 Balloon patient withdrawn to RTS after 6m
• Results so far: NO DIFFERENCE at any stage
ClinicalTrials.gov: NCT02208440; REC ref: 13/NW/0754; Protocol: IS-CL-02-UK; IRAS: 122315

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RCT: InSpace vs Repair for MRCT
ClinicalTrials.gov: NCT02208440; REC ref: 13/NW/0754; Protocol: IS-CL-02-UK; IRAS: 122315

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RCT: InSpace vs Repair for MRCT
• Principal Investigators:
• Stephen Snyder, Southern
California
• Jonathan Bravman, Colorado
• Jonathan Levy, Florida
• Nikhil Verma, Illinois
• Scott Trnhaile, Illinois
• Uma Srikumaran, Maryland
• Anand Murthi, Maryland
• Laurence Higgins,
Massachusetts
• Laith Jazwari, New York
• Samer Hasan, Ohio
• Grant Jones, Ohio
• Joseph Abboud, Pennsylvania
• Ed Rugusky, Pennsylvania

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THANK YOU
MERCI
lenfunk@shoulderdoc.co.uk
Any darn fool can make
something complex;
It takes a genius to make
something simple.
- Albert Einstein