InSpace balloon for massive rotator cuff tears 2017

Selene G. Parekh, MD, MBA

Early provisional results

Health & Medicine

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

@thearmclinic
InSpace Balloon

Our Results & Experience
Wrightington Upper Limb Unit
Lennard Funk

Mike Walton, Puneet Monga

Maria Moffatt

@thearmclinic
Disclaimer
• Study supported by OrthoSpace

@thearmclinic
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

@thearmclinic
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

@thearmclinic
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

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

@thearmclinic
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

@thearmclinic
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• 1 Balloon patient withdrawn to RTS after 6m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

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

@thearmclinic
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

@thearmclinic
THANK YOU

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

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