In Vivo Kinematics of Scapolunate Interosseous Ligament Injuries
Phase: NA
Conditions: Scapholunate Ligament Tear
Sponsor: Massachusetts General Hospital

1 
 
In vivo kinematics of scapholunate interosseous ligament injuries 
 
NCT03017040 
 
Version Date:  22 June 2017

2 
 
PARTNERS HUMAN RESEARCH COMMITTEE 
DETAILED PROTOCOL 
In vivo kinematics of scapholunate interosseous ligament injuries 
Version Date: 6/22/2017 
I. Background and Significance 
The kinematics of scapholunate interosseous ligament (SLIL) injuries are poorly 
understood. Some patients are relatively asymptomatic while other patients have pain and 
difficulty with pushing and loading of the wrist. Even more confounding, some patients 
with complete injury and dissociation of the scaphoid from the lunate may be symptom 
free, while some patients with partial injuries describe substantial wrist dysfunction.  
The kinematics of the wrist may provide insight into this dysfunction. In vivo 
kinematics of the normal wrist has been studied previously, but few studies have 
characterized the wrist with a SLIL injury. In addition, there are few studies evaluating 
validated patient-rated outcomes for patients with SLIL injury. The goal of this study 
would be to evaluate to what degree kinematic abnormalities affect patient-rated 
outcomes. 
A dual fluoroscopic imaging technique has been used to study the kinematics of 
various joints and quantify the variations associated with ligament insufficiency or 
ligament reconstruction.  We propose an in-vivo study on the wrist of patients with SLIL 
injury. This technique should identify any changes in carpal kinematics and may be able 
to be correlated to signs and symptoms of pain and osteoarthritis. 
Our technique provides a direct technique for measurement of wrist kinematics. 
The system is not only a viable solution for the investigation of fully dynamic joint 
kinematics, but also has a low radiation dosage, is non-invasive, and can be constructed 
using any pair of readily available fluoroscopes. Thus, the DFIS provides an easy and 
powerful tool for accurately determining 6DOF positions of healthy, injured, and 
surgically treated wrists in 3D space. 
(1) 
Wolfe SW et al. In vivo scaphoid, lunate, and capitate kinematics in flexion and 
extension. J Hand Surg Am 2000; 25A : 860-9. 
(2) 
Crisco JJ et al. In vivo radiocarpal kinematics and the dart-thrower’s motion. J 
Bone Joint Surg 2005; 87A: 2729- 2739. 
(3) 
Moritomo H et al. Capitate-based kinematics of the midcarpal jooint during wrist 
radioulnar deviation: An in vivo three-dimenstional motion analysis. J Hand Surg 
2004; 29A: 668-675.  
(4) 
Li G et al. In vivo articular cartilage contact kinematics of the knee: an 
investigation using dual-orthogonal fluoroscopy and magnetic resonance image-
based computer models. Am J Sports Med. 2005 Jan;33(1):102-7. 

3 
 
II. Specific aims 
This represents a study on subjects with scapholunate interosseous ligament (SLIL) 
injury and in-vivo joint kinematics analysis based on a new three-dimensional imaging 
method which will integrate images from CT scan and from dual-orthogonal fluoroscopy.  
We hypothesize that there is no relationship between in vivo kinematic abnormalities 
and patient-rated outcomes for scapholunate interosseous ligament injuries (SLIL) 
Our secondary null hypotheses are that: There are no kinematic differences between 
subjects with unilateral, symptomatic, full thickness scapholunate ligament tears in 
comparison to the contralateral wrist without scapholunate ligament injury. 
We also aim to answer to the below questions: 
 What are baseline validated outcomes for subjects with SLIL injury? 
 What are baseline physical measures (range of motion, Jamar Dynamometry)? 
III. Subject selection 
In this pilot study, we will recruit 10 subjects with the below inclusion criteria: 
Inclusion Criteria 
o Patients with a unilateral full thickness scapholunate ligament tear 
diagnosed by radiographs or advanced imaging. 
Exclusion Criteria 
o Patients < 18 years old 
o Patients with partial thickness scapholunate ligament tears 
o Patients with radiographic arthrosis 
o Patients with prior wrist surgery 
o Pregnancy  
Subjects will be identified from the clinical practice of Dr Neal Chen, xxxxxxxx, 
xxxxxxxx, xxxxxxxx, and xxxxxxxx. Plain radiographs of the interest wrist and 
contralateral wrist and MRI of the interest wrist will be performed to confirm the 
diagnosis as a routine practice. Consent procedures are detailed below. 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx. 
IV. Subject Enrollment 
A total number of 10 subjects will be considered for this pilot study. Post-hoc we 
will determine if our sample size is sufficient in order to perform a multivariable logistic 
regression analysis using the rule of thumb to avoid fitting a model with too many 
degrees of freedom in the modeling process. In case we need to enroll higher number of 
subjects, we will inform the IRB to get the approval beforehand.  

4 
 
 
Participation is voluntary.  Prospective subjects will be invited in the clinic after 
being diagnosed and will be provided with a flyer explaining the study. The treating 
physician will ask the subject’s permission to have researchers contact them. A 
researcher who is IRB approved study staff will contact the subject to confirm eligibility, 
explain the study, and set up the first study appointment.  
At the first study visit, the study will first be explained in detail. After reading the 
consent form, subjects will be able to ask additional questions. Xxxxxxxxx who is an 
expert research scientist with more than 9 years of experience in Bioengineering Lab and 
is an IRB approved study staff will obtain informed consent.  
Study procedures 
Pregnant or breast-feeding women will be excluded from participation. During 
each study visit, women of childbearing potential will be questioned and urine tested to 
determine whether they are possibly pregnant. If found pregnant, they will be disqualified 
from the study. If a pregnancy test is required, xxxxxxxxx will confirm the urine test 
kit results and sign the corresponding pregnancy test form. A credentialed, Massachusetts 
licensed physician or a licensed radiological technologist will be operating fluoroscopes. 
V.I. Study visits 
Subjects with a unilateral, full thickness scapholunate ligament tear documented 
by radiographs of the interest and contralateral wrist, MR arthrogram, or MRI of the 
interest wrist as well with no history or radiographic evidence of wrist injury will be 
enrolled. A CT scan of both wrists will be obtained. The contralateral wrist will serve as a 
matched control. 
Participation in this study will require two visits at the Massachusetts General 
Hospital. A research assistant who is IRB approved study staff will contact the subject by 
telephone and/or email to schedule the visits and will ask the subject whether he/she 
would prefer to do the CT scan and Fluoroscopy in either one longer session or two 
separate shorter sessions.  
The first visit after enrolling in this study will be to undergo a CT scan of both wrists. 
This visit will last approximately 60 minutes. The subject will lie motionless with 
outstretched hands on a table that slides into a square donut frame for about 2 minutes. 
Subjects will complete the PRWE, DASH, and SF-12 questionnaires. Questionnaires will 
be completed on paper. Range of motion of both wrists will be assessed using a 
goniometer. Grip force of both wrists will be assessed using Jamar Dynamometer. Pinch 
force will be assessed for both sides using pinch gauge.  
The second visit will last approximately 60 minutes. Images of the both wrists will be 
taken with fluoroscopes, which are able to take digital x-ray pictures. During this visit, 
the subject will perform fully dynamic activities as described below, while the 
fluoroscopes take digital x-rays, one wrist at a time: 
- 
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
- 
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 

5 
 
- 
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
- 
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
- 
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
- 
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
 
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 
 
Each subject will be given a radiation protection apron, a protective thyroid 
shield, and protection for genital region. The first and second visits can be done in the 
same day or 2 separate days, whichever is more convenient for the subject. 
The data obtained from these visits will be transferred to a computer and will be 
used to reconstruct three-dimensional wrist models. It will help researchers better 
understand the association of small bones in the wrist and whether any changes happen in 
their related movements after SLIL injury. 
The CT scan of the contralateral side is designed to answer research questions. 
This CT scan is not a substitute for one a doctor would order. However, if we believe that 
we have found a medical problem in the CT, we will ask a doctor who is trained in the 
reading of CTs, a radiologist, to help us review the images. If the radiologist thinks that 
there may be abnormalities in the CT images, we will contact the subject and will help 
him/her get medical follow-up for the problem.   
V.II. Devices to be used 
Two fluoroscopes (BV Pulsera, Philips, Eindhoven, Netherlands) will be used to 
capture images of the wrist at each extreme motion. The fluoroscope has been developed 
to produce real-time 1K x 1K imaging resolution and has an image intensifier diameter of 
31 cm. When using the two fluoroscopes to obtain orthogonal images, the total imaging 
volume can reach up to 30cm x 30cm x 30cm. Such a system will allow the investigator 
to capture the two images simultaneously, thus minimizing the amount of time that the 
subject must remain still. The operator will perform the imaging via a switch. The 
distance between the source of radiation and the personnel will be approximately 2 
meters. The investigator will also be protected from radiation exposure with appropriate 
lead shielding. In order to monitor radiation exposure, badges will be worn during the 
imaging process. 
The fluoroscope has a clearance of approximately 1 meter between the X-ray 
source and the receiver, allowing the subject to be imaged by the fluoroscopes 
simultaneously throughout the entire range of motion.  
After scanning, the collected imaging data from the CT imaging and the 
fluoroscopy will be transferred to the computers of the Bioengineering Laboratory for 
further data processing. Each subject will be assigned a code for data storage and further 
processing, ensuring confidentiality. The laboratory computers are only accessible to the 
Bioengineering Laboratory members. The imaging files from this study will furthermore 

6 
 
be specifically password protected and therefore will only be accessible to the 
investigators.  
The images of the wrist at each performed motion will be entered into the 
Rhinoceros software program (Robert McNeel & Associates, Seattle, WA), where the 
contours of the wrist bones will be outlined and digitized. The digitized data will then be 
used to construct the contour lines of the bony cross-sections using piecewise polynomial 
curves. Reconstruction of the bony surfaces will be achieved by transforming these 
curves into piecewise polynomial surfaces using the Rhinoceros program. 
V. Biostatistical Analysis 
A total number of 10 subjects will be considered for this pilot study. Post-hoc we 
will determine if our sample size is sufficient in order to perform a multivariable logistic 
regression analysis using the rule of thumb to avoid fitting a model with too many 
degrees of freedom in the modeling process. In case we need to enroll higher number of 
subjects, we will inform the IRB to obtain approval prior to proceeding.  
Data obtained for statistical analysis will include scanning of each wrist at 
different positions beside a grip and leaning position. At each respective position, 
translations, rotations, and gap formation will be measured. 
VI. Risks and Discomforts 
Radiation risks: The following is the revised statement from xxxxxx of the 
Radiation Safety Committee: The subject will be exposed to radiation from the x-rays 
during fluoroscopy. A milliSieverts (mSv) is a unit of measure of radiation dose. The 
worldwide average natural background dose from the earth and the sky for a human being 
is about 3 mSv per year. 
For subjects, the total amount of radiation exposure from full participation in this 
study is equal to a whole body exposure of 0.071 mSv from fluoroscopy. This amount of 
radiation is about the same one would normally receive in 9 days from natural 
background sources from the earth and the sky. 
The fluoroscopy scanning will be performed in a room specifically dedicated to 
this equipment and the study. No other laboratory work will be performed in this room 
during testing. The only persons present during scanning will be the subject and the 
personnel operating the fluoroscope. The room is located at the end of a hallway and its 
door will be closed while operating the fluoroscope. 
The subjects will be provided with lead aprons (0.5 mm thickness), lead thyroid 
shields and lead gonad shields for protection against radiation exposure. 
After positioning the subjects, the personnel handling the fluoroscope will be 
performing the scan via a hand switch. The distance between the source of radiation and 
the personnel will be approximately 2 meters. Furthermore, the personnel will be 
protected with lead aprons (0.5 mm thickness) and lead thyroid shields. In order to 
monitor exposure of personnel, radiation exposure badges will be worn during the 
scanning process. 
The radiation protection aprons, thyroid shields and gonad shields have been 
specifically purchased for this study and will only be used for the purposes of this study. 

7 
 
Dr. Neal Chen or xxxxxx or one on the research fellows which is approved by 
IRB as a study staff will have carefully screened prospective subjects for possible 
contraindications at the initial evaluation. These contraindications include pregnancy and 
breast feeding women. Subjects with these contraindications will be excluded from the 
study. 
Adverse events will be reported promptly to the IRB according to Partners Human 
Research Committee guidelines. 
VII. 
Potential benefits 
We do not expect any direct benefit to any subjects in this study. However, we 
hope that this study contributes important information for the development of joint 
kinematics analysis technique. An improved knowledge of carpal kinematics can inform 
future patients and surgeons and help optimize surgical techniques. 
VIII. Monitoring and Quality Assurance 
The Principal Investigator, Dr. Chen, has overall responsibility for monitoring and 
assuring the validity and integrity of the data and adherence to the IRB-approved 
protocol. All data acquired as specified by this protocol will be maintained and monitored 
by Dr. Chen and xxxxxx at Bioengineering Laboratory. An IRB approved study staff will 
be responsible for collecting the signed consent forms and subject questionnaires. xxxxxx 
will maintain the subject consent forms and questionnaires and review the forms for 
completeness. All electronic data and subject information will be secured on non-
networking password protected computers; all paperwork will be secured in locked filing 
cabinets. 
The Principal Investigator, Dr. Chen, has overall responsibility for data and safety 
monitoring. A credentialed, Massachusetts licensed physician or a licensed radiological 
technologist will be operating fluoroscopes for this study. Subjects are monitored by Dr. 
Chen (or research fellows, approved as study staff) during the time of fluoroscopic image 
acquisition. Other study representatives will also be on hand to assist the subject. 
Participants will be supervised by the clinical technicians of the MGH Imaging 
Department during the MR acquisition. Any discomfort during fluoroscopy or MRI will 
lead to termination of the procedure and excluding the participants from the study. 
The study staff will update the treating physicians on the imaging procedures. The 
treating physicians will decide whether the subject is eligible to continue his or her 
participation in the study. 
The principal investigator will review, analyze, and report to the IRB any adverse 
events according to the guidelines set forth by MGH/Partners. 
All participants are given a participation number/code at the time of enrollment.  This 
code is kept on all data sheets instead of the subject name.  Subject information is only 
accessible by Partners authorized investigators and will not be shared with outside 
entities.  
Questionnaires and self-reported responses will not become part of the subject’s 
medical record and will not contain medical record numbers or names. Hardcopies of 
study related data and forms will be stored in a lockable file cabinet.  Subject information 

8 
 
will remain confidential by keeping identifying information (name, medical record 
number, and subject number) in a separate locked file cabinet.  Only the investigators and 
study staff specified on the consent form will have access to this information.