Embed Size (px)
Citation preview
@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 MongaMaria 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
@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
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
@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• RESULTS (Jan 2017):• 24 subjects:• 14 with 6m data = 9 Balloon & 5 Repair• 1 Balloon patient withdrawn to RTS after 6m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 MRCTClinicalTrials.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 YOUMERCI
Any darn fool can make something complex;
It takes a genius to make something simple.
- Albert Einstein
