Duke University Medical Center
Department of Surgery
In vivo Glenohumeral Contact Analysis
after Anterior Labral Repair:
A postoperative Study
Key Personnel: Lior Laver, MD, Jocelyn Wittstein, MD, Lou Defrate, PhD, Dean
Taylor, MD
Principal Investigator (PI): Dean Taylor, MD
Co-Investigator: Lior Laver, MD, Lou Defrate, PhD
Duke University Medical Center
Department of Surgery
Table of Contents
ABBREVIATIONS _____________________________________________________________ 3
1
INTRODUCTION________________________________________________________
1.1 BACKGROUND __________________________________________________________
1.2 OBJECTIVES ____________________________________________________________
1.3 STUDY DESIGN _________________________________________________________
4
4
4
5
2
PATIENT SELECTION __________________________________________________ 6
2.1 INCLUSION CRITERIA _____________________________________________________ 6
2.2 EXCLUSION CRITERIA ____________________________________________________ 6
3
STUDY CALENDAR _____________________________________________________ 6
4
INTERVENTIONS _______________________________________________________ 6
4.1 IMAGING STUDIES _______________________________________________________ 6
5
FOLLOW-UP ___________________________________________________________ 7
5.1 POST-OPERATIVE CARE ___________________________________________________ 7
5.2 SUBSEQUENT CARE ______________________________________________________ 7
6
EVALUATION OF OUTCOMES___________________________________________ 7
6.1 RESPONSE CRITERIA _____________________________________________________ 7
6.2 OUTCOMES ASSESSMENT __________________________________________________ 7
7
ADVERSE EVENT REPORTING __________________________________________ 7
8
DATA CONSIDERATIONS _______________________________________________ 7
DATA CORRECTIONS/MODIFICATIONS ____________________________________________ 8
9
STATISTICAL CONSIDERATIONS _______________________________________
9.1 STUDY DESIGN/ENDPOINTS ________________________________________________
9.2 SAMPLE SIZE ESTIMATION AND PATIENT ACCRUAL _____________________________
9.3 ANALYTIC PLAN AND METHOD _____________________________________________
8
8
8
8
10 REGULATORY AND ETHICAL CONSIDERATIONS ________________________ 8
10.1 OHRP CONSIDERATIONS __________________________________________________ 8
10.2 INSTITUTIONAL REVIEW BOARD APPROVAL ___________________________________ 8
10.3 RECRUITMENT OF SUBJECTS _______________________________________________ 9
10.4 INFORMED CONSENT PROCESS ______________________________________________ 9
10.5 PROTECTION OF PATIENT RIGHTS __________________________________________ 10
11
REFERENCES _________________________________________________________ 10
12 APPENDICES __________________________________________________________ 13
12.1 ECOG/ZUBROD PERFORMANCE SCALE ______________________________________ 13
12.2 KARNOFSKY PERFORMANCE SCALE _________________________________________ 13
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Duke University Medical Center
Department of Surgery
Abbreviations
AE
CPA
CRF
CTCAE
DCTD
FDA
FWA
HIPAA
IRB
MPA
OHRP
PHI
Adverse Event
Cooperative Project Assurance
Case Report Form
Common Terminology Criteria for Adverse Events
Division of Cancer Treatment and Diagnosis
Food and Drug Administration
Federalwide Assurance
Health Insurance Portability and Accountability Act of 1996
Institutional Review Board
Multiple Project Assurance
Office for Human Research Protection
Protected Health Information
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Duke University Medical Center
1
Introduction
1.1
Background
Department of Surgery
Early attempts at anterior stabilization of the glenohumeral joint were complicated by high rates
of post stabilization arthropathy. Procedures such as the Putti-Platt and Magnuson-Stack
procedures have now been recognized to have resulted in overtightening of the anterior
structures of the shoulder, specifically the subscapularis, presumably resulting in increased
contact stresses on the glenohumeral cartilage surfaces and subsequent degenerative joint
disease. (Van der Zwaag et al JSES 1999, Kiss et al JSES 1998, Hawkins et al JBJA Am 1990)
More modern techniques for stabilizing the glenohumeral joint rely on repairing the torn
capsulolabral junction back to an anatomic position on the anteroinferior glenoid rim. This can
be done using an open or arthroscopic technique. Both open and arthroscopic techniques have
resulted in low recurrence rates of instability, with a slightly greater loss of external rotation
motion in open repairs as compared to arthroscopic repairs.
While the majority of studies report mainly good and excellent results after anterior labral
repairs, rates of development of postoperative glenohumeral arthritis of varying degrees as high
as 20 to 52%. (Bonnevialle et al JSES 2009, Buscayret et al AJSM 2004) The causes of post
stabilization glenohumeral arthritis are not completely well understood but may include the intial
insult at time of injury, delayed time to stabilization, age, use of thermal capsulorrhaphy, use of
intraarticular pain pumps, poor anchor placement, and possibly altered kinematics following the
stabilization procedure. (Bonnevialle et al JSES 2009, Buscayret et al AJSM 2004, Cameron et
al AJSM 2003, Kang et al Arthroscopy 2009, McNickle et al AJSM 2009, Bailie et al JSES
2009, Good et al Arthroscopy 2007, Hansen et al AJSM 2007)
Despite many in vivo, cadaveric, and finite element studies on the biomechanics of the
glenohumeral joint without injury, with and without osteoarthritis, after labral tears and after
labral repairs, the effect of anterior labral repair on the in vivo three-dimensional motion of the
glenohumeral cartilage contact points has not been reported in the literature. (Westerhoff et al J
Biomech 2009, Charlton et al Proc Inst Mech Eng H 2006, van Drogelen et al Arch Phys Med
Rehabil 2005, Wang et al JBJS Am 2005, Anglin et al Proc Inst Mech Eng H 2000, Buchler et al
Clin Biomech 2002, Gupta et al JSES 2005, Gries et al JSES 2002, Brenneke Clinical
Biomechanics 2000, Youm et al JSES 2009, Kelkar JSES 2001)
An accurate knowledge of the in vivo kinematics of the shoulder is important in order to improve
the treatment of shoulder instability. The goal of treatment is to restore native stability and
function to the shoulder. Knowledge of the effect of anterior labral repair on the kinematics of
cartilage contact points in assessing the success of current stabilization techniques in achieving
this goal.
1.2
Objectives
1.2.1
Primary Objective
The aim of this postoperative study is to investigate the kinematics of the glenohumeral joint
after anterior labral repair in shoulders with traumatic, unilateral anterior instability. The
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Duke University Medical Center
Department of Surgery
identification of abnormal cartilage contact points may contribute to a better understanding of the
development and prevention of glenohumeral arthritis after stabilization procedures.
1.2.2
Secondary Objective
N/A
1.3
Study Design
Study subjects will be patients of Dr. Dean Taylor. Potential subjects will be identified by
reviewing Dr. Taylor’s previous surgical cases that included isolated anterior capsulolabral
repairs. Patients meeting the inclusion criteria will be contacted by letter and then by phone and
invited to participate in the study. A key personnel member who is part of the PI’s office staff
and is known to the patient will make the phone contact. The study will be explained and any
questions that the subject may have will be answered at that time. If the subject agrees to
participate in the study, he/she will make an appointment at that time to come in for a study visit.
Only adult patients status post unilateral anterior labral repair a minimum of 2 years postop with
a healthy contralateral shoulder will be asked to take part in this study. Up to 10 people will be
asked to participate in this study. Subjects will undergo range of motion testing, fluoroscopy and
MRI imaging.
First, both the postoperative shoulder and the healthy shoulder of each subject will be imaged
using a 3T MR scanner using a fat-suppressed 3-dimensional (3D) spoiled gradient-echo
sequence. The MR scans will be used to generate sagittal plane images (512 x 512 pixels) with a
field of view of 16 x 16 cm and a spacing of 1 mm.
Subjects will be imaged with a dual-orthogonal fluoroscopic system developed for determination
of in vivo joint kinematics. (Defrate et al Journal of Biomechanics 2004, Li et al, Journal of
Biomechanics Brittish 2003) The subject will perform shoulder abduction to 90 degrees while
holding a 5 pound weight with the arm straight, followed by maximal external rotation at the side
and external rotation at 90 degrees of abduction within 2 orthogonally placed fluoroscopes
(Pulsera, Philips, The Netherlands). The subject will remain still briefly while images are
captured simultaneously from 2 orthogonal directions with the shoulder abducted 90 degrees,
maximally externally rotated at the side and maximally externally rotated at 90 degrees of
abduction. In every patient, the postoperative shoulder will be imaged first, followed by the
healthy shoulder. Active and passive motion of the shoulder for internal rotation, external
rotation, and forward flexion will be measured with a goniometer.
Each MR image will be processed using a Canny filter programmed in a commercially available
mathematics software package (Matlab, Mathworks, Canton, Mass). The Canny filter calculates
gradients in pixel intensity to detect edges between objects. The calculated edges will be used to
help trace the outlines of the glenoid and humerus within each sagittal plane image using solidmodeling software (Rhinoceros, Robert McNeel and Associates, Seattle, Wash). The contours
will be then placed in the appropriate plane in a 3D space, and the surface will be meshed using
the solid-modeling software. In this fashion, 2 shoulder models will be created from each subject:
1 model of the healthy shoulder and 1 model of postoperative shoulder.
The orthogonal images will be then imported into the solid-modeling software to create a virtual
dual-orthogonal fluoroscopic system. The images will be placed in orthogonal planes based on
the geometry of the fluoroscopes. The 3D shoulder model will then be imported into the virtual
fluoroscopic system and will be moved in 6 degrees of freedom until its projection as viewed
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Duke University Medical Center
Department of Surgery
from the 2 orthogonal directions matched the outlines of the 2 fluoroscopic images. Once the
shoulder model is matched to the 2 fluoroscopic images, the position of the model will reproduce
the position of the subject’s shoulder during abduction and external rotation.
1.3.1
Accrual Goal
Up to 10 people will be asked to participate in this study.
2
Patient Selection
Each criterion must be addressed and documented in the patient’s medical record.
2.1
Inclusion Criteria
Study subjects will be patients of Dr. Dean Taylor. Potential subjects will be identified
by reviewing Dr. Taylor’s previous case log. Subjects meeting the inclusion criteria will
be contacted by letter then phone and invited to participate in the study. The study will
be explained and any questions that the subject may have will be answered at that time.
If the subject agrees to participate in the study, he/she will come into Dr. Lou Defrate’s
lab to be consented. Only adult patients status post unilateral anterior labral repair a
minimum of 2 years postop with a healthy contralateral shoulder will be asked to take
part in this study.
2.2
Exclusion Criteria
Patients under the age of 18 years as well as pregnant women will be excluded.
3
Study Calendar
The study participants are scheduled to discuss the study and consent and will only have one visit
lasting approximately two hours in which imaging studies are performed. Therefore no calendar
or follow-up schedule is needed.
4
Interventions
This section gives an overview of the intervention(s) and procedures to be used in this study and
how they are to be applied. The details of the interventions and procedures associated are
described in Section 4.1.
4.1
Imaging Studies
As noted above in the study design section, subjects will undergo MRI of both shoulders as well
as fluoroscopy of both shoulders.
First, both the postoperative shoulder and the healthy shoulder of each subject will be imaged
using a 3T MR scanner using a fat-suppressed 3-dimensional (3D) spoiled gradient-echo
sequence.
Subjects will be imaged with a dual-orthogonal fluoroscopic system developed for determination
of in vivo joint kinematics. The subject will perform shoulder abduction to 90 degrees while
holding a 5 pound weight with the arm straight, followed by maximal external rotation at the side
and external rotation at 90 degrees of abduction within 2 orthogonally placed fluoroscopes
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Duke University Medical Center
Department of Surgery
(Pulsera, Philips, The Netherlands). The subject will remain still briefly while images are
captured simultaneously from 2 orthogonal directions with the shoulder abducted 90 degrees,
maximally externally rotated at the side and maximally externally rotated at 90 degrees of
abduction. In every patient, the postoperative shoulder will be imaged first, followed by the
healthy shoulder. In this fashion, 2 shoulder models will be created from each subject: 1 model
of the healthy shoulder and 1 model of postoperative shoulder.
5
Follow-up
5.1
Post-operative Care- N/A
5.2
Subsequent CareAll patients should be instructed to communicate with the operating physician prior to
accepting any additional therapy.
6
Evaluation of Outcomes
6.1
Response Criteria- N/A
6.2
Outcomes Assessment
We will assess the postoperative shoulders to see how closely the postoperative
shoulder compares to the normal shoulder in terms of range of motion and contact
analysis. Range of motion will be compared using a paired students T test.
7
Adverse Event Reporting
No study-related adverse events will occur that would be attributed to the patient’s
participation in this study. If the patient should raise any medical questions during the
course of this study, the patient will be asked to contact his/her study physician.
8
Data Considerations
The efficient conduct and the quality of clinical trials depend on timely and accurate
collection of data. The procedures to be used for forms completion and data collection
for this study are outlined below. To maximize efficiency, the investigator is expected
to adhere to the procedures as stated here with regards to data collection and form
completion.
Once a subject is registered to the study, information is collected from that subject as
specified in the protocol. This information is recorded on forms, both case report forms
(CRFs) and non-CRFs (i.e., medical record, clinical chart, etc.). The primary objective
of the study will be analyzed through the data collected. It is therefore necessary that
forms are complete and accurate within 72 hours of visit completion.
Data entered on a subject’s CRF will be verified against source documentation that is
found in the subject’s medical records/clinic charts. A CRF cannot serve as a source
document. All CRF data MUST be recorded in source documents prior to entry in the
CRF.
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Duke University Medical Center
Department of Surgery
The CRF cannot be used in lieu of the patient’s medical record. The CRF is used for
transcription of source documentation only.
Data Corrections/Modifications
If an error in completing a CRF is made, a horizontal line (in black ink) is drawn
through the text, initialed and dated. This serves as an audit trail for data modifications.
It also calls the attention to changes that have been made to a form. Liquid Paper
should never be used to correct CRFs.
For numeric and alpha fields, the correct information should be written above or below
the error. Do not try and write the correct information over the erroneous information,
since this will make the data ambiguous and/or illegible.
For choice fields, the correct choice box should be marked. If multiple corrections have
been made to one choice field causing possible ambiguity as to the correct response,
circle the correct choice category and/or write the correct choice response.
NOTE: If in the course of the study the CRFs are modified, the CRF revision date and
version number will be updated.
9
Statistical Considerations
9.1
Study Design/Endpoints
We plan to enroll 10 subjects.
9.2
Sample Size Estimation and Patient Accrual
We cannot perform a sample size calculation or power analysis because there is no
existing data in the literature addressing this clinical question. We are planning on
enrolling 10 subjects.
9.3
Analytic Plan and Method
We plan to compare range of motion between normal and postoperative shoulders using
a paired T test. The comparison of contact areas from the kinematic evaluation will be
a qualitative comparison between the normal and postoperative shoulder. We will make
these comparisons after completing enrollment.
10
Regulatory and Ethical Considerations
10.1
OHRP Considerations
The clinical site must have a valid assurance number from the United States Office for
Human Research Protections (OHRP). Most institutions have a Multiple Project
Assurance (MPA), Cooperative Project Assurance (CPA) number or Federalwide
Assurance (FWA). If the clinical site does not have such an assurance, the clinical site
must apply and obtain an assurance before subjects can be registered to this study.
10.2
Institutional Review Board Approval
It is the investigator’s responsibility to ensure that this protocol is reviewed and
approved by the appropriate IRB. The clinical site must obtain a letter of approval from
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Duke University Medical Center
Department of Surgery
the IRB (full board review) prior to enrolling subjects to this study, as defined by the
following:

Federal Regulatory Guidelines (Federal Register Vol. 46, 8975, January 27,
1981 as amended in Federal Register Vol. 56, 28029, June 18, 1991 and in
Federal Register Vol. 66, 56775, November 13, 2001).

Office of Protection for Research Risks Report: Protection of Human Subjects
(Code of Federal Regulations Title 45, Part 46).
The IRB also must review and approve the site’s informed consent document and any
other written information provided to the subject prior to enrolling subjects.
If, during the study, it is necessary for either the protocol or informed consent document
to be amended, the investigator will be responsible for ensuring the IRB reviews and
approves the amended documents. IRB approval of the amended informed consent
document must be obtained before new subjects consent to participate in the study using
this version of the consent form.
10.3
Recruitment of Subjects
Patients will be recruited for this study as follows:
Study subjects will be patients of Dr. Dean Talyor. Potential subjects will be identified
by reviewing Dr. Taylor’s previous surgical cases that included isolated anterior
capsulolabral repairs. Patients meeting the inclusion criteria will be contacted by letter
and then by phone and invited to participate in the study. A key personnel member who
is part of the PI’s office staff and is known to the patient will make the phone contact.
The study will be explained and any questions that the subject may have will be
answered at that time. If the subject agrees to participate in the study, he/she will make
an appointment at the time to come in to Dr. Lou Defrate’s lab to be consented and
participate in the study (no clinic visit will be generated). Up to 10 people will be asked
to participate in this study. Patients under the age of 18 years as well as pregnant
women will be excluded.
10.4
Informed Consent Process
The investigator or his/her authorized designee will inform the subject or the subject’s
legally authorized representative of all aspects pertaining to the subject’s participation
in the study. The process for obtaining informed consent will be in accordance with all
applicable regulatory requirements (Federal Register Vol. 48, No. 17, 1982, pp 8951-2).
The informed consent document must be signed and dated by both the investigator or
his/her designee and the subject or the subject’s legally authorized representative
BEFORE the subject can participate in the study. The subject will receive a copy of the
study consent form and the signed and dated original copy will be retained in the
subject’s study file or medical record.
Specifically subjects agreeing by phone to be part of the study will be scheduled for an
appointment with Dr. Lou Defrate at his lab in order to be consented. The subject will
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Duke University Medical Center
Department of Surgery
be brought into a private room and given ample time to read and review the informed
consent. The subjects will be allowed to ask questions and all questions will be
answered by research staff prior to signing the informed consent. No research activities
will be carried out prior to the signing of the informed consent.
10.5
10.5.1
Protection of Patient Rights
Protection from Unnecessary Harm
Each clinical site is responsible for protecting all subjects involved in human
experimentation. This is accomplished through the IRB mechanism and the process of
informed consent. The IRB reviews all proposed studies involving human
experimentation and ensures that the subject’s rights and welfare are protected and that
the potential benefits and/or the importance of the knowledge to be gained outweigh the
risks to the individual. The IRB also reviews the informed consent document associated
with each study in order to ensure that the consent document accurately and clearly
communicates the nature of the research to be done and its associated risks and benefits.
The IRB must give full board approval of the protocol and consent documents before
the study may begin at the clinical site.
10.5.2
Confidentiality of Patient Data
The clinical site is responsible for the confidentiality of the data associated with
subjects registered in this study in the same manner it is responsible for the
confidentiality of any subject data within its sphere of responsibility. For subjects
registered to this study, there are additional considerations related to the necessity of
sharing of research data with representatives of the Food and Drug Administration
(PDA) and the National Cancer Institute (NCI).
The Privacy Rule (Title 45, Code of Federal Regulations, Parts 160 and 164), created as
a result of the enactment of the Health Insurance Portability and Accountability Act of
1996 (HIPAA), protects the privacy of individually identifiable health information.
The rule’s requirements also heighten the protection of subject information by
introducing more controls on its use and disclosure. HIPAA refers to subject
information as “protected health information” (PHI). PHI includes any information that
could identify a person, living or dead. To comply with HIPAA’s Privacy Rule, the
subject is required to authorize the use and disclosure of his/her PHI by either signing a
HIPAA-compliant informed consent document or a separate authorization form created
for this purpose. The provisions of the Privacy Rule do not negate the other federal
regulations that govern the protection of subject’s rights relative to data confidentiality
and the use of research data.
11
References
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214(6):637-44.
Bailie DS, Ellenbecker TS. Severe chondrolysis after shoulder arthroscopy: a case series. J Shoulder
Elbow Surg 2009; 18(5):742-7.
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Department of Surgery
Brenneke S. Glenohumeral kinematics and capsulo-ligamentous strain resulting from laxity exams.
Clnical Biomechanivs 2000; 15(10):735-742.
Bonnevialle N, Mansat P, Bellumore Y, et al. Selective capsular repair for the treatment of anteriorinferior shoulder instability: review of seventy-nine shoulders with seven years’ average follow-up. J
Shoulder Elbow Surg 2009; 18(2):251-9.
Buchler P, Ramaniraka NA, Rakotomanana LR. A finite element model of the shoulder: application to
the comparison of normal and osteoarthritic joints. Clin Biomech (Bristol, Avon) 2002; 17(9-10):630-9.
Buscayret F, Edwards TB, Szabo I. Glenohumeral arthrosis in anterior instability before and after
surgical treatment: incidence and contributing factors. Am J Sports Med 2004; 32(5):1165-72.
Cameron ML, Kocher MS, Briggs KK et al. The prevalence of glenohumeral osteoarthritis in unstable
shoulders. Am J Sports Med 2003; 31(1): 53-5.
Charlton IW, Johnson GR. A model for the prediction of the forces at the glenohumeral joint. Proc Inst
Mech Eng H 2006; 220(8):801-12.
DeFrate LE, Sun H, Gill TJ, Rubash HE, Li G.
In vivo tibiofemoral contact analysis using 3D MRI-based knee models.
J Biomech. 2004 Oct;37(10):1499-504.
Good CR, Shindle NK, Kelly BT et al. Glenohumeral chondrolysis after shoulder arthroscopy with
thermal capsulorrhaphy. Arthrsocopy 2007; 23(7):797.e1-5.
Gupta R, Lee TQ. Position-dependent changes in glenohumeral joint contact pressure and force: possible
biomechanical etiology of posterior glenoid wear. J Shoulder Elbow Surg 2005; 14(1 Soopl S):105S110S.
Gries PE, Scuderi MG, Mohr A et al. Glenohumeral contact areas and pressires following labral and
osseous injury to the anterioinferior quadrant of the glenoid.
Hansen BP, Beck CL, Beck EP. Postarthroscopic glenohumeral chondrolysis. Am J Sports Med 2007;
35(10):1619-20.
Hawkins RJ, Angelo RL. Glenohumeral osteoarthritis. A late complication of the Putti-Platt repair. J
Bone Joint Surg Am. 1990; 72(8):1193-7.
Huda W, Gkanatsios NA. Radiation dosimetry for extremity radiographs.
Health Phys. Nov 1998;75(5):492-499.
Kang RW, Frank RM, Nho SJ et al. Complications associated with anterior shoulder instability repair.
Arthroscopy 2009; 25(8):909-920.
Kelkar R, Wang VM, Flatow EL et al. Glenohumeral mechanics: a study of articular geometry, contact,
and kinematics. J Shoulder Elbow Surg 2001; 10(1):73-84.
Kiss J, Mersich I, Perlaky GY et al. The results of the Putti-Platt operation with particular reference to
arthritis, pain, and limitation of external rotation. J Shoulder Elbow Surg. 1998; 7(5):495-500.
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Department of Surgery
Li G, Wuerz TH, DeFrate LE. Feasibility of using orthogonal fluoroscopic images to measure in vivo
joint kinematics.
J Biomech Eng. 2004;126:314–318.
McNickle AG, L’Heureux DR, Provencher MT et al. Postsurgical glenohumeral arthritis in young adults.
Am J Sports Med 2009; 37(9):1784-91.
Van der Zwaag HM, Brand R, Obermann WR et al. Glenohumeral osteoarthritis after Putti-Platt repair. J
Shoulder Elbow Surg. 1999; 8(3): 252-8.
Van Drongelen S, van der Woude LH, Janssen TW. Glenohumeral contact forces and muscle forces
evaluated in wheelchair-related activities of daily living in able-bodied subjects versus subjects with
paraplegia and tetraplegia. Arch Phys Med Rehabil 2005; 86(7):1434-40.
Wang VM, Sugalski MT, Levine WN et al. Comparison of glenohumeral mechanics following a capsular
shift and anterior tightening. J Bone Joint Surg Am 2005; 87(6):1312-22.
Westerhoff P, Graichen F, Bender et al. In vivo measurement of shoulder joint loads during activities of
daily living. J Biomech 2009; 42(12):1840-9.
Youm T, ElAttrache NS, Tibone JE et al. The effect of the long head of the biceps on glenohumeral
kinematics. J Shoulder Elbow Surg 2009; 18(1): 122-9.
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12
Appendices (if applicable)
12.1
ECOG/Zubrod Performance Scale
12.2
Department of Surgery
0
Asymptomatic and fully active.
1
Symptomatic; fully ambulatory; restricted in physical strenuous activity.
2
Symptomatic; ambulatory; capable of self-care; more than 50% of waking
hours are spent out of bed.
3
Symptomatic; limited self-care; spends more than 50% of time in bed, but not
bedridden.
4
Completely disabled; no self-care; 100% bedridden.
Karnofsky Performance Scale
100
Normal, no complaints, no evidence of disease
90
Able to carry on normal activity: minor symptoms of disease
80
Normal activity with effort: some symptoms of disease
70
Cares for self: unable to carry on normal activity or active work
60
Requires occasional assistance but is able to care for needs
50
Requires considerable assistance and frequent medical care
40
Disabled: requires special care and assistance
30
Severely disabled: hospitalization is indicated, death not imminent
20
Very sick, hospitalization necessary: active treatment necessary
10
Moribund, fatal processes progressing rapidly
0
Dead
13