Page 6 - Layout 1

ISAKOS & OREF Grant Winner Announcement

Clinical Application of
2. (Toronto, Canada) – In May 2013, the investigators

met during the ISAKOS Congress 2013 in Toronto, Quantitative Assessment
Canada. Investigators from all Institutions were

of the Pivot Shift–
present (Stefano Zaffagnini, Jon Karlsson, Hakur
Bj̈rnsson, Yuichi Hoshino, Ryosuke Kuroda, Daisuke
A Multicenter Study
Araki, James Irrgang, and Volker Musahl). During
this meeting the investigators discussed progress
November 1, 2012–June 1, 2013 of the study including issues regarding recruitment

and retention, data collection and implementation
of the central data collection system. Additionally,

the investigators discussed the administrative issues
surrounding the distribution of funds to the sites.

Finally, the investigators discussed preliminary study Principle Investigator:
data and preparation of abstracts for upcoming
Volker Musahl, MD

Pittsburgh, PA, USA
professional conferences.

The next investigator meeting is being planned for
October 2013 in Gothenburg, Sweden.

C. Manual of Operations and Procedures

During the investigator meeting in Bologna, the A. Specific Aims

The Specific Aims for the study remain unchanged. investigators agreed on the manual of operations
They are: and procedures (MOOPS). The MOOPs includes

the study protocol, study flow chart, study sites, Specific Aim 1: Determine the relationship in ACL-
training plan, communications plan, recruitment,
screening and eligibility criteria, informed consent deficient knees between quantitative measurements
during the pivot shift test and clinical grading of ACL
and patient confidentiality, description of study
intervention, participant evaluations and follow-up, injury (partial vs. isolated vs. combined injury)

participant retention, concomitant procedures, data Specific Aim 2: Determine the relationship in
and safety monitoring activities, study compliance, ACL-reconstructed knees between quantitative
measurements during the pivot shift test at time-zero
data collection and study forms, data flow, regulatory
documents, retention of study documentation, following reconstruction and post-operative patient-
reported and clinician-measured outcomes at 2 years
administrative forms, data management, quality
control procedures, study completion and closeout Specific Aim 3: Determine the relationship in ACL

procedures, policies, maintenance of the MOOP, and
deficient knees between quantitative measures of
joint kinematics as evaluated with inertial sensors references.

compared to a new video-based iPad application.
During the investigator meeting in Toronto, the
investigators agreed to change the one of the
B. Investigator meetings
inclusion criteria. Patients will be eligible to participate
in the study if they undergo surgery within 1 year 1. (Bologna, Italy)–In October 2012 we had a two-
day investigator meeting at the Rizzoli Institute
of injury.
in Bologna, Italy. Investigators from all Institutions
were present (Gulio Marcheggiani Muccioli, Cecilia

Signorelli, Nicola Lopomo, all Bologna; Yuichi Hoshino,
Ryosuke Kuroda, all Kobe; Kristian Samuelsson,

Gothenburg; James Irrgang, Volker Musahl, all
University of Pittsburgh). During this meeting we
introduced the two devices (accelerometer and iPad-

image analysis) to the investigators. We examined
two patients pre-operatively while awake in the

office using both devices. The next day we had the
opportunity to test both subjects under anesthesia

and observe ACL reconstruction. Time lines were set
for obtaining IRB approval and tentative start date for

enrolment. We discussed translation of our outcome
tools and IRB forms in each institution’s respective

language. Finally, we reviewed and finalized a manual
of operations and procedures (MOOPs).

4 ISAKOS NEWSLETTER 2013: Volume II