12 aaom reeves workshop april 20 research in practice
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Introducing Research Into Your
Orthopedic Medicine Practice
AAOM 29th Annual Conference April 18-21 2012K. Dean Reeves, M.D.
Clinical Associate ProfessorUniversity of Kansas
I. KEY STAGES OF RESEARCH
From Preliminary Idea to Literature Review
•Common•Function Impairing•Clear Rx Advantages•Fast result•Powerful Result•Literature review •Purpose Statement
Pre-Site Choice: Practical Considerations
•Preliminary Team•Outcome Measures •Power Analysis •Precise Hypothesis•Cost Estimates•Site Choices
HSC Application and On-Line Announcement
•Choose HSC•Protocol•Consent•Privacy Form•Phone Screening•Advertising•Send Application•HSC Approval •Clinicaltrials.org
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
● = CompletedN = Not applicable
OSD
RO
TTPRP
BO
KNCAR
RO
TMJ
HK
TMJ
BA
CAUD
HI
CAUD
RO
HAND
RO
HAND
GU
Common ● ● ● ● ● ● ● ● ●Function Impairing ● N ● ● ● ● ● ● ●Clear RxAdvantages
● ● ● ● ● ● ● ● ●
Fast ● ● ● ● ● ● ● ● ●Powerful ● ● ● ● ● ● ● ● ●Purpose Statement ● ● ● ● ● ● ● ● ●Literature Review ● ● ● ● ● ● ● ● ●
From Preliminary Idea to Literature Review
● = CompletedN = Not applicable
OSD
RO
TTPRP
BO
KNCAR
RO
TMJ
HK
TMJ
BA
CAUD
HI
CAUD
RO
HAND
RO
HAND
GU
Preliminary Team ● ● ● ● ● ● ● ● ●Outcome Measures ● ● ● ● ● ● ●Power Analysis ● ● ● ● ● ● ● ● ●Precise Hypotheses ● ● ● ● ● ● ●Cost Estimates ● ● ● ● ● ● ●Site Choice(s) ● ● ● ● ● ● ●
Pre-Site Choice: Practical Considerations
● = CompletedN = Not applicable
OSD
RO
TTPRP
BO
KNCAR
RO
TMJ
HK
TMJ
BA
CAUD
HI
CAUD
RO
HAND
RO
HAND
GU
Choose HSC ● ● ● ● ● ● ●Protocol ● ● ● ● ● ● ●Consent ● ● ● ● ● ● ●Privacy Form ● ● ● ● ● ● ●Phone Screen ● ● ● ● ● ● ●Advertising ● ● ● ● ● ● ●Send Application ● ● ●HSC Approval ● ●Clinicaltrials.org ● ●
HSC Application and On-Line Announcement
Time To Publication From Enrollment27 mo – 57 mo
OSD
RO
TTPRP
BO
KNCAR
RO
TMJ
HK
TMJ
BA
CAUD
HI
CAUD
RO
HAND
RO
HAND
GU
Enroll 6-24 mo ●Follow 1-2 yr ●Submit 2 mo ●Resubmit 2 mo ●Resubmit 2 mo ●Correct Proof 1 mo ●Publication 2 mo ●
From Enrollment to Publication
II. RESEARCH IN PROCESS:
OPPORTUNITIES
Post Exercise RCT Dextrose Cream
• Location: Vancouver
• Primary Investigatory: Helene Bertrand
• Status: Preparing for May 6, 2012 (Vancouver Marathon)
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.
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?”
Vehicle Cream Only for 5 days
Dextrose vs Vehicle Cream for Post Marathon Pain
20 20
1 month recheck for any potential side effects.Comfortable running distance at 1 month
Dextrose + Vehicle Cream BID-TID for 5 days
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.
Knee OA: Double Arthroscopy Protocol
Injection of 12.5% dextrose @ 0, 1, 2, 3, 4, and 5 month. (25% for 2nd group) (9
ml with HRUS guidance)
Arthroscopy #1 Then wait until return to baseline symptoms
Follow for 1 Year with Injection every 2-3 Months if symptomatic
Arthroscopy #2 at 6 Mo
Use medial lift in 2nd group)
Data Gathering 1st
Arth0
Mo6 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 quality.
X
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.
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.
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
3 Mo Data (Grip Pain + AUSCAN)
Finger OA: Dextrose vs Xanthan Gum
Dextrose + Vehicle Cream Xanthan Gum + Vehicle Cream 15 15Nighttime with gloves
Dextrose + Vehicle Cream
12 Mo Data (Grip Pain + AUSCAN)
24 Month Data? (Repeat X-Ray, Grip Pain, AUSCAN
Epidural Dextrose Study
• Location: Hilo Hawaii, Rosario Argentina
• Primary Investigators: Liza Smigel, Gaston Topol (Resident)
• Status: Underway Hilo. Pre HSC Rosario
Randomized Comparison of Immediate Analgesic Effects of 5% Dextrose in Water vs Normal Saline and 1 Year
Outcome Data of 5% Dextrose administration.
10 ml D5W Caudal
NRS Pain + ODI 2.0 at 0 Months
NRS Pain 15 min, 2 hrs, 4 hrs, 48 hrs Unblinded@ 48 hrs, Then 10 ml D5W if Not Received
D5W @ 2, 4, and 6 weeks and PRN. Continued 90% Reduction in Pain 15 Minutes Post Injection?
Y
N
90% or more reduction in Pain 15 minutes after Caudal D5W
10 ml NS Caudal
Offer Other Rx
N
Y NRS Pain + ODI 2.0 at 3 and 12 Months
#15
#15
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
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
6 Month Data Collection
Water/Lido .2% 1 ml @ 0, 1, and 2 mo.
RCT of Dextrose vs Lidocaine Injection for TMD
5 5
1 Year Data
Dex 20%/Lido .2% 1ml @ 0, 1, and 2 mo
PRN Injection
PRN Injection
Pilot Results: NRS Scale Changes 0 to 6 Months For
Dextrose (D) vs Lidocaine (L)
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)
Manual PRP Production
• Location: Beaver, Oregon
• Primary Investigator: Noel Peterson, N.D.
• Status: Underway
PRP: Efficacy of Novice Teaching25 tubes (196 ml total blood draw) FROM each novice preparer
1 tube for baseline testing
6 Tubes Trial 1
0.75 ml from 3 tubes
12 Tubes for PM“Intermittent Input”
trials
12 Tubes for AM“Close Supervision”
trials
6 Tubes Trial 1
0.75 ml from 3 tubes
0.75 ml from 3 tubes
0.75 ml from 3 tubes
0.75 ml from 3 tubes
0.75 ml from 3 tubes
0.75 ml from 3 tubes
0.75 ml from 3 tubes
Cytokine Synovial Fluid Study
• Location: Richmond, VA
• Primary Investigator: Potential Jeff Ericksen/Jason Tucker
• Status: Pending Funding.
Facial/Trigeminal Neuralgia
• Location: Potential Ferrara, Italy
• Potential Primary Investigator: Steven Cavallino
• Status: Design phase pre HSC submission.
ACL Laxity Study
• Location: Open
• Primary Investigator: Open
• Status: Investigator being sought
• KT-2000 confirms 2 mm or greater side to side anterior displacement difference with legs in neutral rotation.
• Partial ACL tear by MRI + No symptoms opposite knee
• Blinded 3 month KT-1000 ADD.
Blinded 12 month KT-1000 ADD
• 9 ml 25% Dex. Inj. @ 0, 1, and 2 mo with HRUS
• Delayed Treatment
• Inject at 3 months and then PRN symptoms at 6, and 9 months
• Inject at 3, 4, 5 and 6 months and PRN at 9 months.
ACL Laxity Correction
Morton’s Neuroma
• Location: Potential Brisbane
• Primary Investigator: Potential podiatrist.
• Status: Investigator recruitment stage
• Design: In preliminary stages
Study Name
• Location
• Primary Investigator:
• Status
• Design
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