Details are given for a range of clinical research projects investigating the use of dextrose injections for various orthopedic conditions, from finger and knee osteoarthritis to ACL laxity and TMJ disorders. The document reviews study locations, investigators, statuses,
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12 aaom reeves workshop april 20 research in practice
1. Introducing
Research Into Your
Orthopedic
Medicine Practice
AAOM 29th Annual Conference April 18-21 2012
K. Dean Reeves, M.D.
Clinical Associate Professor
University of Kansas
3. From Preliminary Idea to Literature Review
•Common
•Function Impairing
•Clear Rx Advantages
•Fast result
•Powerful Result
•Literature review
•Purpose Statement
5. HSC Application and On-Line
Announcement
•Choose HSC
•Protocol
•Consent
•Privacy Form
•Phone Screening
•Advertising
•Send Application
•HSC Approval
•Clinicaltrials.org
6. From Enrollment To Publication
•Enroll 6-24 Mo
•Follow 1-2 Yr
•Submit/hear back 3 Mo
•Resubmit/hear back 3 mo
•Correct Proof 1 mo
•Publication 3 mo
7. From Preliminary Idea to Literature Review
O T K T T C C H H
● = Completed
S T N M M A A A A
N = Not applicable D P C J J U U N N
R A D D D D
P R
R B R H B H R R G
O O O K A I O O U
Common ● ● ● ● ● ● ● ● ●
Function Impairing ● N ● ● ● ● ● ● ●
Clear Rx ● ● ● ● ● ● ● ● ●
Advantages
Fast ● ● ● ● ● ● ● ● ●
Powerful ● ● ● ● ● ● ● ● ●
Purpose Statement ● ● ● ● ● ● ● ● ●
Literature Review ● ● ● ● ● ● ● ● ●
8. Pre-Site Choice: Practical Considerations
O T K T T C C H H
● = Completed
S T N M M A A A A
N = Not applicable D P C J J U U N N
R A D D D D
P R
R B R H B H R R G
O O O K A I O O U
Preliminary Team ● ● ● ● ● ● ● ● ●
Outcome Measures ● ● ● ● ● ● ●
Power Analysis ● ● ● ● ● ● ● ● ●
Precise Hypotheses ● ● ● ● ● ● ●
Cost Estimates ● ● ● ● ● ● ●
Site Choice(s) ● ● ● ● ● ● ●
9. HSC Application and On-Line Announcement
O T K T T C C H H
● = Completed
S T N M M A A A A
N = Not applicable D P C J J U U N N
R A D D D D
P R
R B R H B H R R G
O O O K A I O O U
Choose HSC ● ● ● ● ● ● ●
Protocol ● ● ● ● ● ● ●
Consent ● ● ● ● ● ● ●
Privacy Form ● ● ● ● ● ● ●
Phone Screen ● ● ● ● ● ● ●
Advertising ● ● ● ● ● ● ●
Send Application ● ● ●
HSC Approval ● ●
Clinicaltrials.org ● ●
10. From Enrollment to Publication
O T K T T C C H H
Time To Publication
S T N M M A A A A
From Enrollment D P C J J U U N N
27 mo – 57 mo R A D D D D
P R
R B R H B H R R G
O O O K A I O O U
Enroll 6-24 mo ●
Follow 1-2 yr ●
Submit 2 mo ●
Resubmit 2 mo ●
Resubmit 2 mo ●
Correct Proof 1 mo ●
Publication 2 mo ●
12. Post Exercise RCT Dextrose
Cream
• Location: Vancouver
• Primary Investigatory: Helene
Bertrand
• Status: Preparing for May 6, 2012
(Vancouver Marathon)
13. Dextrose vs Vehicle Cream for Post Marathon Pain
Leg pain > 5/10 Post Marathon
Willing to apply cream three times daily? If yes, Randomize.
Treat both sides if opposite side has pain. Gather data on each leg
that has pain > 5/10.
20 20
Dextrose + Vehicle Cream Vehicle Cream Only for 5 days
BID-TID for 5 days
E mail Data collection of AM NRS daily X 5 days.
At end of 5 days a 7 point Likert Scale response will be requested
to the questions “I plan to use a cream like this in the future?”
1 month recheck for any potential side effects.
Comfortable running distance at 1 month
14. Arthroscopic Study Cartilage
Growth
• Location: Rosario
• Primary Investigator: Gaston
Topol
• Status: 1st group of 6 with 12.5%
dextrose completed. 2nd group of 6
underway with 25% dextrose.
15. Knee OA: Double Arthroscopy Protocol
Arthroscopy #1 Then wait until return
to baseline symptoms
Injection of 12.5% dextrose @ 0, 1, 2, 3,
4, and 5 month. (25% for 2nd group) (9
ml with HRUS guidance)
Use medial lift in 2nd group)
Arthroscopy #2 at 6 Mo
Follow for 1 Year with Injection
every 2-3 Months if symptomatic
16. Data Gathering
1st 0 6 Mo
Arth Mo
WOMAC X X
Walking Pain X X
Walking Distance X X
Extension Lack X X
Total flexion X X
Arthroscopic Video Pre/post MB X X
Biopsy of growth area for cartilage X
quality.
17. Histological Investigations
• Methylene Blue: Shows cartilage buds.
• Hematoxin and Eosin Staining: Column orientation
(organized cartilage) vs sporadic clumped (degenerative
cartilage)
• Saff O: Mucopolysaccharide (MPS) activity measure.
Pale in OA (dying cartilage). Red with regeneration .
• Polarized light: Fibrocartilage shows fibers
distinctly. Hyaline cartilage shows glassy
appearance. (No fibers)
• Collagen typing: type 1 in fibrous tissue; type II in
both fibrous and hyaline cartilage. Not essential but
orthopedic community will enquire.
• Mechanical properties: Not possible on small biopsy
and not expected.
18. Finger OA RCT: Dextrose
Cream
• Location: Guadalajara, Buenos
Aires
• Potential Primary Investigators:
David de la Mora, Irene Briseno,
Gonzalo Yamauchi.
• Status: Cream approval issues
blocking HSC approval in 1 site.
Pre-HSC submission in 2nd.
19. Finger OA: Dextrose vs Xanthan Gum
3 months of bilateral finger pain (Minimum 6/10) +
At least one painful joint on fingers 2-5 +
No finger “sticking”/No Painful flexor nodule +
No worse pain in other areas +
Inflammatory arthritis lab testing negative
15 Nighttime with gloves 15
Dextrose + Vehicle Cream Xanthan Gum + Vehicle Cream
3 Mo Data (Grip Pain + AUSCAN)
Dextrose + Vehicle Cream
12 Mo Data (Grip Pain + AUSCAN)
24 Month Data? (Repeat X-Ray, Grip Pain, AUSCAN
20. Epidural Dextrose Study
• Location: Hilo Hawaii, Rosario
Argentina
• Primary Investigators: Liza
Smigel, Gaston Topol (Resident)
• Status: Underway Hilo. Pre HSC
Rosario
21. Randomized Comparison of Immediate
Analgesic Effects of 5% Dextrose in
Water vs Normal Saline and 1 Year
Outcome Data of 5% Dextrose
administration.
22. NRS Pain + ODI 2.0 at 0 Months
#15 #15
10 ml D5W Caudal 10 ml NS Caudal
NRS Pain 15 min, 2 hrs, 4 hrs, 48 hrs Unblinded@ 48 hrs,
Then 10 ml D5W if Not Received
90% or more reduction in Pain 15 minutes after Caudal D5W
Y N
D5W @ 2, 4, and 6 weeks and PRN. Offer
Continued 90% Reduction in Pain 15 N
Other
Minutes Post Injection? Rx
Y
NRS Pain + ODI 2.0 at 3 and 12 Months
23. Dextrose TMJ Study
• Location: Buenos Aires, Hong
Kong
• Primary Investigator: Miguel
Zarate, Ricardo Frusso, Stanley
Lam.
• Status: Near HSC approval. Delay
prior to HSC submission. Pilot
completed
24. RCT of Dextrose vs Lidocaine Injection for TMD
Facial Pain > 5/10 + Jaw symptoms > 5/10
+ Exam for Obvious Dental Issues?
Symptoms referable to jaw after exam? If Yes, Randomize.
Treat both sides if opposite side has pain or jaw dysfunction, but
gather data on the worst side
5 5
Dex 20%/Lido .2% 1ml Water/Lido .2% 1 ml
@ 0, 1, and 2 mo @ 0, 1, and 2 mo.
PRN Injection
6 Month Data Collection
PRN Injection
1 Year Data
25. Pilot Results: NRS Scale Changes
0 to 6 Months For
Dextrose (D) vs Lidocaine (L)
26. P Values for 10 Subject Study:
0 to 6 Months
• Multivariate analysis Dextrose Vs Lidocaine: Dextrose
better (p = .049)
• Univariate analysis Dextrose vs Lidocaine
Dextrose better in pain improvement (p = .013
Dextrose better in function improvement (p = .020)
28. PRP: Efficacy of Novice Teaching
25 tubes (196 ml total blood draw) FROM each novice preparer
12 Tubes for AM 12 Tubes for PM 1 tube for
“Close Supervision” “Intermittent Input” baseline
trials trials testing
6 Tubes 6 Tubes
Trial 1 Trial 1 0.75 0.75 0.75 0.75
ml ml ml ml
from from from from
3 3 3 3
tubes tubes tubes tubes
0.75 0.75 0.75 0.75
ml ml ml ml
from from from from
3 3 3 3
tubes tubes tubes tubes
29. Cytokine Synovial Fluid Study
• Location: Richmond, VA
• Primary Investigator: Potential Jeff
Ericksen/Jason Tucker
• Status: Pending Funding.
31. ACL Laxity Study
• Location: Open
• Primary Investigator: Open
• Status: Investigator being sought
32. ACL Laxity Correction
• Partial ACL tear by MRI + No symptoms opposite knee
• KT-2000 confirms 2 mm or greater side to side anterior
displacement difference with legs in neutral rotation.
• 9 ml 25% Dex. Inj. • Delayed
@ 0, 1, and 2 mo Treatment
with HRUS
• Blinded 3 month KT-1000 ADD.
• Inject at 3 months and • Inject at 3, 4, 5 and 6
then PRN symptoms at months and PRN at
6, and 9 months 9 months.
Blinded 12 month KT-1000 ADD
34. Study Name
• Location
• Primary Investigator:
• Status
• Design
Notas do Editor
Outcome measures for the hand study depend on approval of cream or dextrose. If dextrose we may go back to measurement of joint size.
Methylene Blue: Stains all soft tissue but not bone. Intense and capable of staining surface cartilage buds. H&E: Standard initial testing for cellular nature, number and orientation. Organized cartilage will have columnar orientation and degenerative cartilage will appear sporadic and clumped. Least useful but required for complete results. Saff O: In DJD not much activity since cells are dying. In regeneration MPS activity is high. Mechanical Properties: Lanny has other scientific support for durability in publications for regrown cartilage.
I adjusted the volume based on our confirmation today that ACD collects between 8-8.5 ml of whole blood per tube here on the West coast. Higher elevations will get less. I was not able to re-arrange the boxes to allow for 8 0.75 ml from 3 tubes boxes. I think that the 0.75 ml extraction works very well in our course, and we have settled on it as our benchmark. So there are two blood draws of 12 tubes each, and 8 attempts at concentrations total. You could call this 4 trials.
