Policy Forum : Studying Eyewitness Investigations in the Field This article considers methodological issues arising from recent efforts to provide field tests of eyewitness identification procedures . We focus in particular on a field study -LRB- Mecklenburg 2006 -RRB- that examined the `` double blind , sequential '' technique , and consider the implications of an acknowledged methodological confound in the study . We explain why the confound has severe consequences for assessing the real-world implications of this study . One of the most interesting products of the first wave of wrongful convictions exposed by DNA has been a vigorous debate over potential changes in the design and execution of the lineups and photographic arrays , familiar to every television viewer , that police rely on to probe memory in eyewitness cases , the category that dominates the exoneration lists . All of the current proposals for change in investigative practice derive from extensive laboratory inquiry , and they have at their cores the novel `` double-blind , sequential '' technique for conducting eyewitness identification procedures . In this technique the law enforcement personnel conducting an identification procedure are `` blind '' concerning which person in the lineup or photo array is the police suspect , and they present the `` fillers '' and the suspect to the witness individually -LRB- `` sequentially '' -RRB- rather than in a group -LRB- `` simultaneously '' -RRB- , as in the traditional practice . The changes from current procedure are designed to ensure that witnesses discern no inadvertent cues as to which individual they should or should not identify , to encourage witnesses to compare each individual they see to the remembered image of the criminal -LRB- rather than to make a relative , `` looks-most-like , '' judgment comparing the individuals displayed to each other -RRB- , and to eliminate unnecessary `` feedback '' to witnesses who have made a selection and might look to the lineup administrator for confirmation or contradiction . Everyone agrees that proposed changes in investigative practice should be tested in the field , but moving from the laboratory to the field has always been problematic . The proper design of field studies used to evaluate new procedures in the field has become an important issue . Two recent efforts at field-testing the `` double-blind , sequential '' option have taken place . The first , conducted by several departments in Hennepin County , Minnesota , produced results consistent with those predicted by the laboratory scientists , but made no explicit comparison to traditional practices , and it has not been controversial . -LRB- Klobuchar et al. 2006 -RRB- . The second field study , conducted in three Illinois jurisdictions under the direction of the general counsel for the Chicago Police , Sheri Mecklenburg , and documented at length in a report -LRB- usually referred to as `` The Mecklenburg Report , '' after its author -RRB- appeared to contradict both the laboratory scientists ' predictions and the sparse existing field data on eyewitness performance -LRB- Mecklenburg 2006 -RRB- . The Mecklenburg report stated that in two of the three jurisdictions reporting , the traditional method of an aware , `` not-blind '' detective displaying the suspect and `` fillers '' in a group to the witness produced a lower rate of identifications of innocent fillers and a higher rate of identifications of suspects than did the lab-generated `` double-blind , sequential '' technique . The recommendation of the Mecklenburg Report , in other words , was that the system should not institute changes on the basis of the laboratory science . The Mecklenburg Report was vigorously publicized , and it immediately drew both determined support and sharp criticism from psychologists who had long been interested in the issue of eyewitness investigative procedures . Unfortunately for criminal justice practitioners who must decide whether procedures should be changed , the early scientific commentaries on the Mecklenburg Report generally aligned with the views on the potential of these particular procedural innovations that the commentators had announced throughout their long careers of involvement with the issue of eyewitness memory . Seizing on this , partisans on both sides of the debate over procedures have unfairly dismissed some criticism and praise of the Mecklenburg Report as reflecting nothing more than the scientific commentators ' stubborn loyalty to their own pre-existing beliefs . A standoff has arisen . Although everyone agrees that further field studies are required , practitioners considering future field studies have been left to wonder whether they should simply repeat the Illinois Study described in the Mecklenburg Report , or attempt to find a new design . We have read the materials related to the Mecklenburg study , including the Mecklenburg Report , its Addendum and Appendices , the supportive comments of Dr. Roy Malpass -LRB- 2006 -RRB- and Dr. Ebbe Ebbesen -LRB- 2006 -RRB- , and the critical comments of Dr. Gary Wells -LRB- 2006 -RRB- and Dr. Nancy Steblay -LRB- 2006 -RRB- . The Report indicates , and all commentators seem to agree , that the study does contain a confound : a non-blind simultaneous procedure is compared with a blind sequential procedure . The bottom line issue here , or at least the one that drew our group 's attention , concerns the importance of the confound . It is easy to understand the sentiment expressed by Mecklenburg in her Addendum that not all variables can be controlled in a field study such as the one she designed and describes in the Report . Confounds can occur in laboratory studies as well as field studies . The issue that always arises in such cases concerns the implications of the confound : Is it critically related to interpreting the major outcome of the study ? Or is the confound incidental to the main conclusion , such that even though the confound is acknowledged , the major results of the study are still interpretable ? The Mecklenburg Report asserts that `` The Illinois Pilot Study was properly designed to answer the question : how do the current procedures compare with the proposed procedures , both in terms of identification rates and implementation ? '' From this perspective , the confound between blind/non-blind and sequential/simultaneous would not be critical , because non-blind simultaneous reflects the current procedure to which the blind/sequential procedure is compared . Unfortunately , this perspective seems seriously problematic . Our reading of the materials forces us to conclude that the confound has devastating consequences for assessing the real-world implications of this particular study . If it is the case that the better outcome from the non-blind/simultaneous procedure is partly or entirely attributable to subtle , unintentional cues provided by the administrator , then the Illinois results may simply underscore that the present procedure produces a biased outcome that may ultimately result in the increased conviction of innocent individuals . Stated slightly differently , it is critical to determine whether the seemingly better result from the simultaneous procedure is attributable to properties of the simultaneous procedure itself , or to the influence of the non-blind administrator . We should note that under these testing conditions , if the results had shown the sequential lineup to be superior , one would not know whether it was really the use of the sequential lineup or the use of a blind investigator conducting the lineup that produced the result . Of course , any difference between conditions could be due to some combination of the factors . Even if no difference in outcome occurred between the procedures , one could not safely conclude there is no difference between them if the detectives were informed in one condition and not in the other . Thus , although the conditions used in the study made some sense from a practical standpoint , the design guaranteed that most outcomes would be difficult or impossible to interpret . The only way to sort this out is by conducting further studies including , at a minimum , a blind/simultaneous condition -LRB- it would also be desirable to include a non-blind/sequential condition to fill out the design , but it is not an absolutely necessary condition for the present purposes -RRB- . In the materials we have reviewed , the Mecklenburg Report 's detractors -LRB- including Wells -RRB- and its advocates -LRB- including Mecklenburg herself -RRB- disagree on whether the misidentification rates in two of the three participating jurisdictions -LRB- a zero rate of `` filler '' identifications -RRB- are suspiciously low . However , Wells cites enough evidence that they may be low to justify the concern that administrator bias is operating , either consciously or unconsciously ; either by failing to count tentative `` filler '' choices , or in steering witnesses away from fillers , or toward suspects . The problem is that we can not know on the basis of the Mecklenburg study whether such bias is operating , even though the entire interpretation of the significance of the study for real-world practices hinges on this issue . Mecklenburg states in her Addendum that the question of how blind administrators affect simultaneous lineups is one of several questions to be addressed in future studies . We certainly hope so . But the statement that follows is problematic : `` However , the Illinois Pilot Program was not intended to answer those questions and any attempt to discredit the Illinois study on that basis is misguided . '' If the Illinois study was not designed to address the question of what happens in a blind/simultaneous line-up , given its centrality to the issue , then our assessment is that the Illinois study addressed a question -LRB- comparing blind/sequential and non-blind/simultaneous -RRB- that is not worth addressing , because the results do not inform everyday practice in a useful manner . No single field study can produce a final blueprint for procedural reform ; we will need many . The design of these studies , however , will be crucial . A well-designed field study that avoids the flaw built into the Illinois effort , can be an important first step toward learning what we need to know about the best practices in identification procedures .

O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O


Effects

of

biophysical

stimulation

in

patients

undergoing

arthroscopic

reconstruction

of

anterior

cruciate

ligament

prospective

randomized

and

double

blind

study

Pre-clinical

studies

have

shown

that

treatment

by

pulsed

electromagnetic

fields

-LRB-

PEMFs

-RRB-

can

limit

the

catabolic

effects

of

pro-inflammatory

cytokines

on

articular

cartilage

and

favour

the

anabolic

activity

of

the

chondrocytes

Anterior

cruciate

ligament

-LRB-

ACL

-RRB-

reconstruction

is

usually

performed

by

arthroscopic

procedure

that

even

if

minimally

invasive

may

elicit

an

inflammatory

joint

reaction

detrimental

to

articular

cartilage

In

this

study

the

effect

of

I-ONE

PEMFs

treatment

in

patients

undergoing

ACL

reconstruction

was

investigated

The

study

end-points

were

-LRB-

-RRB-

evaluation

of

patients

functional

recovery

by

International

Knee

Documentation

Committee

-LRB-

IKDC

-RRB-

Form

-LRB-

-RRB-

use

of

non-steroidal

anti-inflammatory

drugs

-LRB-

NSAIDs

-RRB-

necessary

to

control

joint

pain

and

inflammation

The

study

design

was

prospective

randomized

and

double

blind

Sixty-nine

patients

were

included

in

the

study

at

baseline

Follow-up

visits

were

scheduled

at

and

days

followed

by

follow-up

interview

Patients

were

evaluated

by

IKDC

Form

and

were

asked

to

report

on

the

use

of

NSAIDs

Patients

were

randomized

to

active

or

placebo

treatments

active

device

generated

a

magnetic

field

of

mT

at

Hz

Patients

were

instructed

to

use

the

stimulator

-LRB-

I-ONE

-RRB-

for

h

per

day

for

days

All

patients

underwent

ACL

reconstruction

with

use

of

quadruple

hamstrings

semitendinosus

and

gracilis

technique

At

baseline

there

were

no

differences

in

the

IKDC

scores

between

the

two

groups

At

follow-up

visits

the

Health

Survey

score

showed

a

statistically

significant

faster

recovery

in

the

group

of

patients

treated

with

I-ONE

stimulator

-LRB-

P

-RRB-

NSAIDs

use

was

less

frequent

among

active

patients

than

controls

-LRB-

P

-RRB-

Joint

swelling

resolution

and

return

to

normal

range

of

motion

occurred

faster

in

the

active

treated

group

-LRB-

P

-RRB-

too

The

follow-up

did

not

shown

statistically

significant

difference

between

the

two

groups

Furthermore

for

longitudinal

analysis

the

generalized

linear

mixed

effects

model

was

applied

to

calculate

the

group

time

interaction

coefficient

this

interaction

showed

a

significant

difference

-LRB-

P

-RRB-

between

the

active

and

placebo

groups

for

all

investigated

variables

Health

Survey

IKDC

Subjective

Knee

Evaluation

and

VAS

Twenty-nine

patients

-LRB-

in

the

active

group

in

the

placebo

group

-RRB-

underwent

both

ACL

reconstruction

and

meniscectomy

when

they

were

analysed

separately

the

differences

in

Health

Survey

scores

between

the

two

groups

were

larger

then

what

observed

in

the

whole

study

group

-LRB-

P

-RRB-

The

results

of

this

study

show

that

patient

's

functional

recovery

occurs

earlier

in

the

active

group

No

side

effects

were

observed

and

the

treatment

was

well

tolerated

The

use

of

I-ONE

should

always

be

considered

after

ACL

reconstruction

particularly

in

professional

athletes

to

shorten

the

recovery

time

to

limit

joint

inflammatory

reaction

and

its

catabolic

effects

on

articular

cartilage

and

ultimately

for

joint

preservation

Introduction

Articular

cartilage

performs

mechanical

functions

absorbing

the

different

loads

applied

to

a

joint

in

the

course

of

daily

activity

-LSB-

-RSB-

Homeostasis

and

mechanical

competence

of

cartilage

are

regulated

by

the

activity

of

the

chondrocytes

that

maintain

the

function

and

the

integrity

of

the

extracellular

matrix

proteoglycans

and

collagen

In

consideration

of

the

scant

repairability

of

the

cartilage

even

modest

damages

resulting

from

trauma

or

inflammation

may

be

the

starting

point

for

cartilage

degeneration

leading

over

time

to

extensive

lesions

that

deepen

into

the

thickness

of

the

cartilage

itself

ultimately

exposing

the

subchondral

bone

tissue

-LSB-

-RSB-

Joint

injury

may

involve

synovial

tissue

cartilage

and

subchondral

bone

leading

to

joint

inflammation

swelling

and

pain

Surgical

interventions

must

certainly

be

included

among

the

triggers

of

inflammatory

reaction

in

a

joint

-LSB-

-RSB-

The

development

of

arthroscopic

procedures

has

undoubtedly

limited

joint

damage

associated

to

surgery

for

reconstruction

of

ligaments

nevertheless

it

does

not

avoid

the

inflammatory

response

Thus

while

arthroscopic

procedures

make

surgery

less

invasive

the

inflammatory

response

at

the

joint

remains

and

the

release

of

pro-inflammatory

cytokines

in

the

synovial

fluid

is

associated

with

an

increase

in

the

aggrecanase

activities

that

lead

to

a

degradation

of

the

cartilage

matrix

and

also

inhibit

proteoglycan

synthesis

-LSB-

-RSB-

To

prevent

cartilage

damage

current

pharmacological

therapies

aim

to

control

the

catabolic

effects

of

the

pro-inflammatory

cytokines

and

enhance

anabolic

activity

proteoglycan

synthesis

and

proliferation

of

chondrocytes

Drugs

that

combine

the

above

effects

are

called

chondroprotectors

in

this

category

should

be

included

drugs

with

adenosine

receptor

agonist

activity

able

to

stimulate

the

physiological

pathways

that

control

inflammation

and

promote

chondrocyte

anabolic

activities

Nevertheless

these

drugs

are

in

early

stages

of

clinical

testing

-LSB-

-RSB-

Pre-clinical

studies

have

shown

that

pulsed

electromagnetic

fields

-LRB-

PEMFs

-RRB-

in

vitro

favour

the

proliferation

of

chondrocytes

-LSB-

-RSB-

stimulate

proteoglycan

synthesis

-LSB-

-RSB-

and

demonstrate

an

adenosine

receptor

agonist

activity

-LSB-

-RSB-

Electromagnetic

fields

in

vivo

prevent

degeneration

of

articular

cartilage

and

down-regulate

the

synthesis

and

release

of

pro-inflammatory

cytokines

in

the

synovial

fluid

-LSB-

-RSB-

These

findings

suggest

that

electromagnetic

fields

may

be

used

to

control

joint

inflammation

and

to

stimulate

cartilage

anabolic

activities

finally

resulting

in

chondroprotection

A

clinical

study

performed

in

patients

undergoing

arthroscopic

treatment

for

cartilage

lesions

showed

that

biophysical

treatment

with

PEMFs

was

well

tolerated

by

the

patients

and

led

to

a

decrease

in

the

use

of

non-steroidal

anti-inflammatory

drugs

-LRB-

NSAIDs

-RRB-

and

to

an

early

functional

recovery

the

positive

effect

of

the

treatment

was

maintained

at

a

follow-up

-LSB-

-RSB-

Arthroscopic

reconstruction

is

the

treatment

of

choice

following

anterior

cruciate

ligament

-LRB-

ACL

-RRB-

rupture

although

minimally

invasive

the

procedure

is

associated

with

joint

reaction

involving

the

synovia

and

it

is

expected

to

lead

to

an

increase

of

pro-inflammatory

cytokines

in

the

synovial

fluid

with

catabolic

effect

on

articular

cartilage

In

this

study

we

evaluated

whether

the

treatment

with

PEMFs

could

be

used

to

control

joint

inflammatory

response

in

patients

undergoing

ACL

reconstruction

The

end

points

of

the

study

were

-LRB-

-RRB-

patients

functional

recovery

evaluated

by

International

Knee

Documentation

Committee

-LRB-

IKDC

-RRB-

form

-LRB-

-RRB-

use

of

NSAIDs

necessary

to

control

joint

pain

and

inflammation

Materials

and

methods

Patients

and

study

design

In

patients

undergoing

ACL

reconstruction

were

evaluated

for

inclusion

in

the

study

at

five

clinical

centres

Of

these

gave

their

informed

consent

to

participate

in

the

study

The

prospective

randomized

and

double-blind

study

was

approved

by

the

local

ethical

committees

Inclusion

criteria

were

the

following

age

between

and

years

ACL

complete

lesion

following

acute

trauma

or

consequence

of

ligament

chronic

degeneration

All

lesions

were

documented

by

MRI

and

confirmed

during

the

intervention

The

following

were

the

exclusion

criteria

osteonecrosis

of

the

femoral

condyle

rheumatoid

arthritis

autoimmune

disease

systemic

disease

and

patients

requiring

meniscus

repair

The

patients

were

assigned

to

the

active

or

placebo

group

according

to

the

following

randomization

criteria

age

-LRB-

or

-RRB-

sex

smoking

status

origin

of

ACL

rupture

-LRB-

traumatic

or

degenerative

-RRB-

For

randomization

of

patients

a

computer-generated

schedule

was

prepared

by

a

biostatistician

In

this

process

a

random

number

seed

was

entered

into

the

computer

to

generate

a

list

that

assigned

equal

numbers

of

active

and

placebo

stimulators

The

minimum

number

of

patients

per

group

required

was

calculated

by

power

analysis

taking

into

account

the

results

of

a

previous

study

-LSB-

-RSB-

Of

the

patients

included

two

never

started

the

therapy

two

dropped

out

within

weeks

of

therapy

and

five

did

not

return

at

follow-up

visits

a

total

of

patients

were

therefore

available

for

subsequent

analysis

The

ACL

rupture

occurred

during

sports

activity

in

patients

-LRB-

active

and

placebo

-RRB-

daily

activity

in

eight

patients

-LRB-

four

active

and

four

placebo

-RRB-

and

traffic

accident

in

three

patients

-LRB-

three

active

-RRB-

At

the

time

of

ACL

reconstruction

patients

underwent

also

meniscectomy

in

the

active

group

and

in

the

placebo

Clinical

evaluation

The

patients

were

evaluated

by

IKDC

Form

before

the

intervention

and

at

and

days

afterwards

The

different

parts

of

the

questionnaire

IKDC

Current

Health

Assessment

Form

-LRB-

Health

Survey

-RRB-

IKDC

Subjective

Knee

Evaluation

Form

and

IKDC

Knee

Examination

Form

were

analysed

separately

As

regards

the

scores

of

the

questionnaires

for

each

subject

we

considered

the

changes

at

follow-up

visits

with

respect

to

the

values

recorded

at

baseline

before

surgery

Pain

intensity

was

evaluated

by

visual

analogue

scale

-LRB-

VAS

-RRB-

of

length

cm

no

pain

cm

maximum

pain

The

patients

were

allowed

to

use

NSAIDs

to

control

knee

pain

when

present

and

had

to

report

doing

so

A

follow-up

telephone

interview

was

conducted

and

the

patients

were

asked

-LRB-

a

-RRB-

if

they

had

undergone

further

surgery

at

the

knee

-LRB-

b

-RRB-

if

they

had

pain

at

the

knee

-LRB-

c

-RRB-

if

they

had

functional

limitation

in

daily

activity

-LRB-

d

-RRB-

if

they

returned

to

previous

sport

activity

level

Surgical

technique

ACL

arthroscopic

repair

was

performed

by

quadruple

hamstrings

semitendinosus

and

gracilis

technique

Tendons

were

harvested

with

the

tendons

stripper

through

a

cm

vertical

incision

on

the

antero-medial

tibial

area

Diameter

of

the

quadruple

hamstrings

semitendinosus

and

gracilis

tendons

was

measured

while

the

tibial

tunnel

and

same

size

femoral

tunnel

-LRB-

mm

length

-RRB-

were

prepared

The

graft

was

pulled

up

through

the

tibial

tunnel

with

the

knee

at

of

flexion

and

suspended

on

the

external

femoral

cortex

-LRB-

Endobutton

Smith

and

Nephew

London

UK

-RRB-

Distally

the

graft

was

fixed

with

an

interference

absorbable

screw

at

the

tibia

at

of

flexion

Rehabilitation

All

the

patients

underwent

standard

rehabilitation

using

passive

knee

flexion

daily

Exercises

started

within

the

third

post-operative

day

with

isometric

quadriceps

contractions

and

then

progressed

to

active

closed-chain

exercises

by

weeks

postoperatively

During

the

first

days

patients

were

instructed

to

use

two

crutches

and

then

progressive

weight

bearing

until

the

end

of

the

second

month

Biophysical

stimulation

The

patients

were

treated

with

active

or

placebo

devices

The

active

stimulators

-LRB-

I-ONE

IGEA

Carpi

Italy

-RRB-

generated

a

magnetic

field

of

peak

intensity

of

mT

at

a

frequency

of

Hz

no

heat

or

vibration

was

felt

by

the

patient

during

treatment

-LRB-

Fig.

-RRB-

Fig.

I-ONE

PEMFs

generator

Right

wave

form

of

magnetic

field

mT

peak

value

-LRB-

top

-RRB-

electric

field

induced

in

a

standard

coil

probe

made

of

turns

-LRB-

cm

-RRB-

of

copper

wire

-LRB-

mm

-RRB-

peak

value

mV/cm

-LRB-

bottom

-RRB-

The

patients

were

instructed

to

use

the

stimulator

for

h

per

day

not

necessarily

consecutively

for

days

Treatment

started

within

days

from

the

surgery

Each

device

contained

a

clock

to

monitor

the

hours

of

use

Statistical

analysis

The

results

were

analysed

with

SPSS

-LRB-

Statistical

Packages

for

Social

Sciences

Inc

Chicago

IL

USA

-RRB-

Comparison

among

the

continuous

variables

in

the

two

groups

was

performed

with

Student

's

heteroschedastic

t

test

comparison

of

continuous

variables

within

each

group

during

follow-up

was

performed

with

Student

's

paired

t

test

Binomial

and

categorical

variables

were

compared

by

contingency

tables

applying

the

chi-square

test

for

tables

and

the

Cochran

Mantel

Haenszel

test

for

larger

size

tables

Generalized

linear

mixed

effects

model

was

applied

to

the

Health

Survey

IKDC

Subjective

Knee

Evaluation

and

VAS

data

to

test

if

a

different

trend

between

the

two

groups

was

present

during

follow-up

by

correcting

for

the

following

covariates

sex

age

weight

height

hours

of

treatment

smoking

status

use

of

NSAIDs

In

this

analysis

a

mathematical

model

is

built

which

takes

into

account

the

trend

over

time

of

individual

patients

belonging

to

each

group

-LRB-

Group

Time

interaction

-RRB-

and

determines

if

a

statistical

difference

exists

between

the

groups

during

the

follow-up

-LSB-

-RSB-

The

minimum

significance

level

for

all

the

statistical

tests

was

set

at

P

Results

At

baseline

the

two

groups

of

study

were

homogeneous

for

age

weight

height

VAS

Health

Survey

and

IKDC

Subjective

Knee

Evaluation

score

-LRB-

Table

-RRB-

Table

of

the

groups

at

baselinePlacebo

Health

IKDC

Subjective

Knee

Evaluation

Average

daily

treatment

was

the

same

in

both

groups

h/die

versus

h/die

in

the

I-ONE

group

and

the

placebo

group

respectively

-LRB-

P

n.s.

-RRB-

The

average

pain

was

modest

and

almost

absent

at

months

follow-up

cm

among

placebo

and

cm

among

active

At

days

less

patients

in

the

active

group

used

NSAIDs

in

the

I-ONE

group

versus

in

the

placebo

group

-LRB-

P

-RRB-

The

Health

Survey

score

decreased

significantly

at

days

in

both

groups

-LRB-

P

-RRB-

At

days

the

mean

Health

Survey

score

in

the

I-ONE

patients

already

exceeded

the

initial

value

-LRB-

by

points

-RRB-

whereas

in

the

patients

of

the

placebo

group

Health

Survey

score

was

slightly

below

the

initial

mean

value

-LRB-

by

units

-RRB-

At

months

a

significant

-LRB-

P

-RRB-

increase

was

observed

for

Health

Survey

average

values

in

both

groups

the

patients

of

the

I-ONE

group

were

above

the

initial

values

by

units

while

the

placebo

group

exceeds

the

baseline

value

by

units

The

mean

changes

of

Health

Survey

score

in

the

I-ONE

group

are

systematically

higher

with

respect

to

placebo

during

follow-up

P

-LRB-

Fig.

-RRB-

Fig.

changes

of

Health

Survey

-LRB-

SE

-RRB-

versus

baseline

in

the

two

groups

-LRB-

P

-RRB-

The

IKDC

Subjective

Knee

Evaluation

score

increased

over

months

and

did

not

show

significant

differences

between

the

two

groups

at

any

follow-up

visit

The

IKDC

Knee

Examination

Form

outlined

both

groups

including

subjects

with

joint

swelling

before

surgery

-LRB-

one

in

placebo

and

two

in

I-ONE

group

P

n.s.

-RRB-

and

at

days

follow-up

-LRB-

five

in

placebo

and

six

in

I-ONE

group

P

n.s.

-RRB-

On

day

joint

swelling

was

observed

in

the

placebo

group

-LRB-

two

patients

-RRB-

only

Joint

swelling

was

not

observed

any

more

at

months

follow-up

Limitation

in

the

passive

range

of

motion

of

the

knee

was

more

frequent

in

the

placebo

group

than

in

the

I-ONE

group

-LRB-

P

-RRB-

-LRB-

Fig.

-RRB-

Fig.

with

limitation

in

passive

range

of

motion

in

the

two

groups

P

Finally

the

generalized

linear

mixed

effects

analysis

revealed

a

significantly

different

trend

-LRB-

group

time

interaction

P

-RRB-

between

the

two

groups

for

Health

Survey

score

IKDC

Subjective

Knee

Evaluation

score

and

for

VAS

showing

a

positive

effect

of

I-ONE

treatment

The

estimate

coefficients

and

significance

of

independent

variables

for

three

models

are

displayed

in

Table

Table

linear

mixed

effects

models

in

which

the

dependent

variables

considered

are

Health

Survey

score

IKDC

Subjective

Knee

Evaluation

score

and

VAS

respectivelyCoefficientStd

err.z

testP

Health

Survey

Hours

of

treatment

Sex

Weight

Age

Smoking

Use

of

NSAIDs

Group

IKDC

Subjective

Knee

Evaluation

Group

Hours

of

treatment

Sex

Weight

Age

Smoking

status

Use

of

NSAIDs

Group

VAS

Hours

of

treatment

Smoking

Use

of

NSAIDs

Time

Group

Time

Constant

The

Group

Time

interaction

term

describes

the

different

trend

between

the

groups

At

the

follow-up

interview

of

the

patients

in

the

I-ONE

group

and

in

the

placebo

group

reported

complete

functional

recovery

no

knee

pain

and

return

to

sport

activity

ACL

reconstruction

and

meniscectomy

When

the

cohort

of

patients

undergoing

both

ACL

reconstruction

and

meniscectomy

was

analysed

separately

the

Health

Survey

score

confirmed

the

faster

recovery

trend

among

I-ONE

treated

patients

compared

to

placebo

P

-LRB-

Fig.

-RRB-

At

months

Health

Survey

average

score

increase

was

in

the

I-ONE

group

-LRB-

P

vs.

baseline

-RRB-

and

in

placebo

group

-LRB-

P

ns

vs.

baseline

-RRB-

Further

the

average

values

of

Health

Survey

were

significantly

higher

in

the

I-ONE

group

compared

to

the

placebo

-LRB-

vs.

P

-RRB-

Fig.

undergoing

ACL

and

meniscectomy

mean

changes

of

Health

Survey

-LRB-

SE

-RRB-

versus

baseline

in

the

two

groups

-LRB-

P

-RRB-

The

percent

of

patients

with

limitation

in

the

passive

range

of

motion

was

lower

in

the

I-ONE

group

compared

to

the

placebo

one

-LRB-

I-ONE

vs.

placebo

at

day

and

I-ONE

vs.

placebo

at

day

P

-RRB-

Discussion

Arthroscopic

surgery

has

gained

a

large

success

and

led

to

a

significant

increase

in

its

use

about

procedures

are

performed

in

the

USA

each

year

-LSB-

-RSB-

However

the

access

into

the

joint

space

is

always

associated

to

an

inflammatory

reaction

that

may

jeopardize

the

benefits

expected

from

surgery

Joint

inflammation

has

a

catabolic

effect

on

extracellular

matrix

and

inhibits

chondrocyte

activity

thus

all

means

capable

of

locally

controlling

the

inflammation

should

be

adopted

to

prevent

the

onset

and

limit

the

progression

of

cartilage

damage

Furthermore

unlike

bone

tissue

after

damage

the

cartilage

will

not

completely

recover

its

competence

once

lost

the

articular

cartilage

does

not

reform

-LSB-

-RSB-

Many

efforts

are

made

to

develop

strategies

able

to

control

joint

inflammation

and

to

favour

the

anabolic

activities

of

chondrocytes

these

are

challenging

objectives

and

up

to

now

the

pharmacological

approaches

based

on

the

use

of

drugs

whether

by

systemic

or

by

local

route

have

not

yet

been

able

to

demonstrate

a

genuine

chondroprotective

effect

in

humans

-LSB-

-RSB-

Pre-clinical

studies

have

shown

PEMFs

to

have

a

chondroprotective

effect

mediated

by

the

control

of

inflammation

and

by

the

stimulation

of

chondrocyte

activity

thus

we

hypothesized

that

after

arthroscopic

surgery

PEMFs

treatment

can

be

used

for

articular

cartilage

protection

and

ultimately

joint

preservation

This

prospective

randomized

and

double-blind

study

investigated

whether

and

to

what

extent

the

employment

of

I-ONE

by

controlling

joint

reaction

to

arthroscopy

could

accelerate

functional

recovery

in

patients

undergoing

ACL

reconstruction

The

I-ONE

treatment

was

well

tolerated

by

the

patients

and

no

adverse

side

effects

were

observed

The

results

show

that

at

days

after

surgery

in

I-ONE

group

significantly

fewer

patients

used

NSAIDs

to

control

pain

compared

to

patients

in

the

placebo

group

afterwards

the

use

of

NSAIDs

was

not

necessary

in

either

group

When

IKDC

Subjective

Knee

Evaluation

average

scores

were

analysed

we

found

no

statistically

significant

difference

between

the

I-ONE

and

placebo

group

this

is

in

agreement

with

the

findings

of

other

authors

who

reported

that

this

parameter

does

not

correlate

with

the

other

clinical

information

collected

using

the

Health

Survey

form

-LSB-

-RSB-

However

when

the

results

of

the

two

groups

were

analysed

by

generalized

linear

mixed

effects

model

which

takes

into

account

the

trend

of

each

patient

in

both

groups

and

the

effect

of

confounding

factors

we

could

evidence

a

positive

significant

effect

of

I-ONE

treatment

also

in

the

Subjective

Knee

Evaluation

-LRB-

Table

-RRB-

The

Health

Survey

average

scores

at

baseline

were

the

same

in

the

I-ONE

and

placebo

groups

however

the

high

standard

deviation

testify

the

large

distribution

of

initial

score

values

To

monitor

patient

's

recovery

after

ACL

reconstruction

we

considered

the

Health

Survey

score

changes

with

respect

to

baseline

for

each

individual

subject

At

and

months

Health

Survey

increase

is

undoubtedly

higher

in

I-ONE

group

than

in

the

placebo

group

This

result

indicates

a

faster

recovery

in

the

treated

patients

This

positive

effect

of

I-ONE

treatment

is

confirmed

by

the

generalized

linear

mixed

effects

analysis

Further

when

the

cohort

of

patients

who

underwent

both

ACL

reconstruction

and

meniscectomy

was

analysed

we

observed

that

the

average

increase

of

Health

Survey

at

days

in

the

I-ONE

group

was

the

same

as

that

of

placebo

group

at

months

-LRB-

vs.

P

n.s.

-RRB-

The

IKDC

Knee

Examination

Form

showed

how

in

the

placebo

group

the

resolution

of

joint

swelling

and

the

recovery

of

complete

range

of

motion

occur

later

compared

to

the

I-ONE

group

no

significant

difference

in

scoring

was

observed

among

centres

The

study

end-points

were

thus

demonstrated

fewer

patients

in

the

I-ONE

group

required

the

use

of

NSAIDs

and

their

functional

recovery

was

faster

At

follow-up

no

statistically

significant

difference

was

observed

between

two

groups

although

the

percent

of

patients

with

complete

recovery

was

slightly

higher

in

the

I-ONE

group

In

this

study

we

applied

a

statistical

analysis

specifically

developed

for

longitudinal

studies

that

allows

to

calculate

the

group

time

interaction

This

test

that

considers

individual

patient

's

score

at

different

time

points

and

the

possible

influence

of

confounding

factors

supports

the

positive

effect

of

I-ONE

treatment

on

the

recovery

of

patients

undergoing

ACL

reconstruction

Our

data

confirm

the

results

reported

by

Zorzi

et

al.

-LSB-

-RSB-

in

a

group

of

patients

treated

with

I-ONE

following

an

arthroscopic

treatment

for

cartilage

lesions

To

the

authors

knowledge

there

are

no

other

reports

of

use

of

biophysical

stimulation

after

surgical

procedures

of

the

knee

Biophysical

stimulation

allows

treating

individual

joints

permeating

the

whole

cartilage

surface

and

thickness

the

synovia

and

the

subchondral

bone

The

effectiveness

of

biophysical

stimulation

is

not

limited

by

considerations

such

as

diffusion

ability

and

concentration

gradient

which

are

present

and

important

in

the

dynamic

of

a

pharmacological

intervention

joint

tissues

are

paramagnetic

they

do

not

attenuate

the

biophysical

signal

and

thus

are

all

homogenously

exposed

to

the

treatment

efficacy

Biophysical

stimulation

is

an

effective

therapeutic

intervention

to

control

the

detrimental

consequences

of

the

inflammation

over

articular

cartilage

in

the

absence

of

negative

side

effects

I-ONE

should

always

be

considered

after

ACL

reconstruction

particularly

in

professional

athletes

to

shorten

the

recovery

time

to

limit

joint

inflammatory

reaction

and

ultimately

for

joint

preservation

O O O O O O O O O O B I I O O O O O O O O O O O O O O O B I I O O O O O O O O O O O O O O O O O O O O O O O B I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O 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anterior cruciate ligament
chondroprotection
pulsed electromagnetic fields
joint preservation