12 aaom reeves workshop april 20 research in practice

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