Ligament Reconstruction Tendon Interposition Versus Internal Brace for the Surgical Treatment of Thumb Carpometacarpal Arthritis: a Prospective Randomized Trial Pilot Study
Phase: NA
Conditions: Thumb Carpometacarpal Osteoarthritis
Sponsor: Washington University School of Medicine

 
 
 
 
 
 
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1 
 
 
 
LRTI versus InternalBrace for the Surgical Treatment of Thumb 
Carpometacarpal Arthritis: a Prospective Randomized Trial Pilot 
Study 
 
Principal Investigator:  Charles A. Goldfarb, MD 
 
 
 
 
 
 
 
Version Date/Number: 9/8/2019 
 
 
 

 
 
 
 
 
 
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2 
TABLE OF CONTENTS 
 
A 
INTRODUCTION ................................................................................................................................. 3 
A1 
STUDY ABSTRACT ........................................................................................................................... 3 
A2 
PRIMARY HYPOTHESIS .................................................................................................................... 4 
A3 
PURPOSE OF THE STUDY PROTOCOL ............................................................................................... 4 
B 
BACKGROUND ................................................................................................................................... 4 
B1 
PRIOR LITERATURE AND STUDIES AND RATIONALE FOR THIS STUDY ............................................. 4 
C 
STUDY OBJECTIVES ......................................................................................................................... 6 
C1 
STUDY AIMS AND RATIONALE FOR SELECTION OF OUTCOME MEASURES ...................................... 6 
D 
STUDY DESIGN ................................................................................................................................... 7 
D1 
OVERVIEW OR DESIGN SUMMARY .................................................................................................. 7 
D2 
SUBJECT SELECTION AND WITHDRAWAL ........................................................................................ 9 
2.a 
Inclusion Criteria ..................................................................................................................... 10 
2.b 
Exclusion Criteria .................................................................................................................... 10 
2.c 
Subject Recruitment Plans and Consent Process .................................................................... 10 
2.d 
Randomization Method and Blinding ...................................................................................... 10 
2.e 
Risks and Benefits .................................................................................................................... 10 
2.f 
Early Withdrawal of Subjects and When and How to Withdraw Subjects .............................. 10 
2.g 
Data Collection and Follow-up for Withdrawn Subjects ........................................................ 10 
E 
STUDY PROCEDURES ..................................................................................................................... 10 
E1 
SCREENING FOR ELIGIBILITY ........................................................................................................ 11 
E2 
SCHEDULE OF MEASUREMENTS, VISITS, SAFETY AND ADVERSE EVENTS .................................... 11 
E3 
STUDY OUTCOME MEASUREMENTS AND ASCERTAINMENT .......................................................... 11 
F 
STATISTICAL PLAN ........................................................................................................................ 11 
F1 
SAMPLE SIZE DETERMINATION AND POWER ................................................................................. 11 
F2 
ANALYSIS PLAN AND STATISTICAL METHODS .............................................................................. 11 
G 
DATA HANDLING AND RECORD KEEPING ............................................................................. 12 
G1 
CONFIDENTIALITY AND SECURITY ................................................................................................ 12 
H 
STUDY ADMINISTRATION ............................................................................................................ 12 
H1 
ORGANIZATION AND PARTICIPATING CENTERS ............................................................................ 12 
H2 
FUNDING SOURCE AND CONFLICTS OF INTEREST .......................................................................... 12 
H3 
SUBJECT STIPENDS OR PAYMENTS ................................................................................................ 12 
H4 
STUDY TIMETABLE ....................................................................................................................... 12 
I 
PUBLICATION PLAN ....................................................................................................................... 13 
J 
ATTACHMENTS ............................................................................................................................... 13 
J1 
INFORMED CONSENT DOCUMENTS ................................................................................................. 13 
J2 
PATIENT EDUCATION BROCHURES ................................................................................................. 13 
K 
REFERENCES .................................................................................................................................... 13 
 

 
 
 
 
 
 
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3 
A Introduction 
 
A1 Study Abstract 
Carpometacarpal osteoarthritis (CMC OA) is a prevalent and disabling disease. 
Trapeziectomy with ligament reconstruction and tendon interposition (LRTI), the most 
frequently performed procedure for CMC OA, requires prolonged postoperative 
immobilization which limits patients' abilities to perform ADLs and to work. Trapezium 
excision and internal brace (IB) stabilization is a largely unstudied novel alternative to 
LRTI which allows an expedited return to work/activity. In this feasibility and pilot grant 
application, our overall objective is to investigate critical questions to inform the planning 
of a definitive randomized controlled trial (RCT) comparing IB and LRTI for patients with 
CMC OA. Our central hypothesis is that a prospective RCT comparing LRTI and IB is 
feasible, and that IB will produce superior patient-reported outcomes to LRTI at 6 weeks 
and 3 months with an expedited return to work/activity. Our specific aims are to (1) 
establish feasibility of a definitive trial by determining the randomization rate and follow-
up retention rate, (2) estimate effect sizes and variability in outcomes for planning a 
definitive RCT, and (3) characterize objective clinical outcomes (thumb range of motion, 
grip/pinch strength, radiographic outcomes, complications/need for additional surgery) 
and to identify differences in return to work/activity following IB and LRTI. To achieve our 
aims, we will randomize 50 patients as they present to the clinics of the 7 Washington 
University Orthopaedic Hand surgeons to LRTI (control) or IB (experimental). Patients 
will follow-up at 2 weeks, 4 weeks, 3 months, and 1 year post-operatively. Our primary 
outcome will be feasibility (randomization rate, follow-up retention rate). Secondary 
outcomes will be PROMIS and Visual Analog Scale Pain and Satisfaction scores at 6 
weeks and 3 months, objective clinical outcomes (thumb range of motion, grip/pinch 
strength, radiographic outcomes, complications/need for additional surgery), and return 
to work/activity. 
 
Upon completion of our aims, we expect to demonstrate that a prospective, randomized 
trial comparing LRTI and IB is feasible, and that patients who undergo IB will have 
superior short-term patient-reported outcomes to those who undergo LRTI. Furthermore, 
we will generate effect size and variability estimates for a definitive, subsequent RCT. 
Should the objectives for this study be successful, we expect to take an important first 
step in defining the role of the IB procedure in the treatment of CMC OA. 
A2 Primary Hypothesis 
Our central hypothesis is that a prospective, randomized trial comparing LRTI and IB 
is feasible, and that IB will produce superior patient-reported outcomes to LRTI at 6 
weeks and 3 months with an expedited return to work/activity. 
A3 Purpose of the Study Protocol 
The purpose of our study protocol is to investigate critical questions to inform the 
planning of a definitive randomized controlled trial (RCT) comparing IB and LRTI for 

 
 
 
 
 
 
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4 
patients with CMC OA. We expect to demonstrate that a prospective, randomized trial 
comparing LRTI and IB is feasible, and that patients who undergo IB will have superior 
short-term patient-reported outcomes to those who undergo LRTI. Furthermore, we will 
generate effect size and variability estimates for a definitive, subsequent RCT. Should 
the objectives for this study be successful, we expect to take an important first step in 
defining the role of the IB procedure in the treatment of CMC OA. 
B Background 
 
B1 Prior Literature and Studies and Rationale for this Study 
Thumb carpometacarpal osteoarthritis (CMC OA) is a common disease, affecting up to 
25% of women and 8% of men, and is increasing in prevalence with the aging 
population1-3. When symptomatic, loss of thumb function can impart up to 50% 
impairment to the upper extremity13. Nonoperative treatments for thumb CMC OA 
include activity modification, splinting, anti-inflammatory medications, and intra-articular 
corticosteroid injections14. When nonoperative treatments fail, surgery may be 
considered. 
 
Surgeries for advanced thumb CMC OA all incorporate trapezium excision to eliminate 
painful bony contact. The majority of hand surgeons in the United States supplement 
trapeziectomy 
with 
suspension 
using 
the 
FCR 
tendon 
(Figure 
1)15. 
This 
suspensionplasty is touted to reduce subsidence of the thumb metacarpal and improve 
pinch strength over simple trapeziectomy. However, LRTI using the FCR tendon 
increases surgical time, increases perioperative complications, and increases costs of 
surgery. Postoperatively, patients are typically placed in rigid immobilization for 4-6 
weeks and require 3 months of healing prior to strengthening. Despite both the 
popularity and heightened direct/indirect costs, comparative studies have not 
demonstrated any long term benefit of LRTI over simple trapeziectomy and hematoma 
arthroplasty. Gangopadhyay et al16 randomized 174 thumbs to trapeziectomy alone, 
LRTI, or trapeziectomy and palmaris longus interposition. Of the 153 thumbs with ≥5 
years follow-up, 78% had good results and pain relief was durable, and there were no 
differences in pain, function (grip/pinch strength), or complications among the three 
groups. In their 2015 Cochrane Review, Wajon et al demonstrated no benefit to pain or 
function from LRTI compared to simple trapeziectomy, although they acknowledged that 
the evidence was of low quality17. 
 

 
 
 
 
 
 
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5 
 
Figure 118: Steps in trapeziectomy with LRTI. A: Trapeziectomy. B: Reconstruction performed with a LRTI 
using FCR tendon. Radial half of FCR tendon passed through a tunnel in base of first metacarpal. C: 
Tendon sutured to itself as a space-filling arthroplasty, augmented by Kirschner wire to prevent subsidence. 
 
Hand surgeons, however, continue to perform LRTI secondary to the desire to provide 
mechanical support for the thumb metacarpal and to avoid the exposed Kirschner wires 
(K-wires) associated with simple trapeziectomy. Recently, techniques have been 
described that provide immediate internal suspension of the thumb metacarpal after 
trapeziectomy without requiring prolonged immobilization or painful K-wires19-21. Internal 
brace (IB, Figure 2), a technology used in ligament augmentation in lateral ankle 
instability, syndesmosis injuries, and scapholunate ligament reconstruction 22-24, has 
been used at our institution for thumb CMC OA with encouraging outcomes in the short-
term (unpublished data). The IB procedure allows the patient to forego postoperative 
casting or K-wire pinning and return to all activities at 6 weeks. 
 
 
Figure 225: Illustration of internal brace procedure. Trapeziectomy is performed in standard fashion. 
Longitudinal traction is applied to the thumb. A suture anchor with suture tape is inserted into a drill hole at 
the radial aspect of the thumb metacarpal base. A second suture anchor is inserted into a drill hole at the 
radial base of the index metacarpal such that the suture tape suspends the thumb at the natural groove. 
Thumb position and tension are then assessed. 
 

 
 
 
 
 
 
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6 
To date, the literature lacks high level clinical evidence to define IB’s role in the 
treatment of thumb CMC OA. A prospective, randomized controlled trial (RCT) is 
required to compare the procedure’s effectiveness in relieving pain and restoring 
function against that of LRTI. Therefore, we propose a pilot RCT comparing patient-
reported outcomes following IB and LRTI to establish feasibility and generate 
effect size and variability estimates for a definitive, subsequent RCT (Aims 1 & 2). 
Recognizing that objective clinical measures such as thumb range of motion, 
grip/pinch 
strength, 
radiographic 
outcomes, 
and 
complications/need 
for 
additional surgery are critical in measuring IB’s effectiveness against LRTI, we will 
characterize the two procedures with respect to these parameters along with 
return to work/activity (Aim 3). 
 
Upon successful completion of the proposed research, we expect to (1) demonstrate 
that randomization into a prospective RCT comparing IB and LRTI is feasible, (2) obtain 
estimates to inform the sample size and design of a future adequately powered 
prospective RCT, and (3) show that IB produces superior patient-reported outcomes at 6 
weeks and 3 months to LRTI while offering an expedited return to work/activity. 
 
C Study Objectives 
 
C1 Study Aims and Rationale for Selection of Outcome 
Measures 
Aim 1: Establish feasibility of a definitive trial by determining the proportion of 
eligible subjects who agree to randomized treatment and determining the follow-
up retention rate. Rationale: To date, no studies have compared IB and LRTI for thumb 
CMC OA. Our study will assess the feasibility of a prospective RCT comparing outcomes 
of the two procedures. Hypothesis: A prospective RCT comparing outcomes of IB and 
LRTI is feasible, as defined by the ability to successfully recruit and randomize ≥50 
patients over the course of 1 year with a follow-up retention rate of ≥90%. 
 
Aim 2: Estimate effect sizes and variability in patient-reported outcomes for 
planning a definitive, two-arm RCT. Rationale: We will assess patient-reported 
outcomes (PROMIS UE/physical function, VAS pain, VAS satisfaction) following IB and 
LRTI. Effect size and variability estimates are required to inform the design of a future 
definitive trial. Hypothesis: IB will produce superior patient-reported outcomes to those of 
LRTI at 6 weeks and 3 months. 
 
Aim 3: Characterize objective clinical outcomes (thumb range of motion, 
grip/pinch 
strength, 
radiographic 
outcomes, 
and 
complications/need 
for 
additional surgery) and to identify differences in return to work/activity following 
IB and LRTI at three months. Rationale: Objective clinical outcomes are important 
predictors of patient function after surgery for thumb CMC OA. IB offers an expedited 
return to work and activity by allowing patients to forego postoperative casting. 
Hypothesis: IB will produce similar objective outcomes to LRTI with a quicker return to 
work/activity. 
 

 
 
 
 
 
 
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7 
D Study Design  
 
D1 Overview or Design Summary 
Our study has been registered on ClinicalTrials.gov. All facets of our study design, 
analysis, and interpretation will adhere to Consolidated Standards of Reporting Trials 
(CONSORT) guidelines. Data will be managed using REDCap (Research Electronic 
Data Capture) electronic data capture tools hosted at our institution. REDCap is a 
secure, web-based application designed to support data capture for research studies, 
providing: 1) an intuitive interface for validated data entry; 2) audit trails for tracking data 
manipulation and export procedures; 3) automated export procedures for seamless data 
downloads to common statistical packages; and 4) procedures for importing data from 
external sources. 
 
The research team will identify potential participants as they present to the clinics of one 
of our seven Orthopaedic Hand and Upper Extremity surgeons. The study population will 
consist of patients aged 50 years and older who are English-speaking and community-
dwelling. These patients will have a confirmed diagnosis of isolated thumb CMC arthritis. 
Patients will not have carpal tunnel syndrome (to avoid outcome data confusion), 
rheumatoid/inflammatory arthritis, or a history of chronic opioid use. The research team 
will block randomize the participants into a control group (LRTI) and a comparison group 
(IB); block sizes will be 4, 6, and 8. 
 
Study Aim 1 
The team will review patients’ medical records and radiographs to determine potential 
participants’ eligibility. The team will recruit eligible individuals during their clinic 
appointments using an information form outlining the benefits and relative limitations of 
each procedure. Patients who are interested in participating in the study will undergo 
initial testing at their clinic appointment, at which time they can also provide informed 
consent. Feasibility will be recorded by means of randomization rate and follow-up 
retention rate throughout the enrollment process. In the event that a patient declines 
randomization into our study, we will record the patient’s reason for declining. 
 
Following the consent process, the study will proceed as follows: 
1. Patient will undergo the surgery to which they are randomized, either LRTI or IB, 
performed by one of the seven Washington University orthopaedic hand surgeons. 
2. All patients will follow-up in clinic 2 weeks, 4 weeks, 3 months, and 1 year post-
operatively. 
 
Patients will undergo a standardized postoperative recovery and therapy regimen: 
 

 
 
 
 
 
 
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8 
 
 
Study Aims 2 & 3 
PROMIS Physical Function and Upper Extremity scores will be collected at all clinic 
visits on iPad as per standard protocol for all patients presenting to a Washington 
University 
Orthopaedic 
Surgery 
clinic. 
Thumb 
ROM 
at 
carpometacarpal, 
metacarpophalangeal, and interphalangeal joints will be collected by a member of our 
team at 4 weeks, 3 months, and 1 year after surgery. Visual Analog Scale Pain and 
Satisfaction scores will be collected by a member of our team at 2 weeks, 4 weeks, 3 
months, and 1 year post-op. Grip and pinch strength (3-point and lateral vs contralateral 
values and vs preoperative values) will be collected at pre-op visit and all post-op visits 
except the 2 week visit. Radiographic subsidence will be measured via C-arm 
radiographs at 3 months and 1 year post-op. Complications (mild, moderate, severe) will 
be recorded throughout the course of the study at all time points. Mild complications will 
be defined as those with minor clinical impact (i.e., scar tenderness or sensory 
disturbances). Moderate complications will be defined as clinically relevant with delay in 
patient recovery, but not severe enough to necessitate revision surgery and resolve by 
12 months after surgery (i.e., mild CRPS type I, tendinitis, neuromas treated with steroid 
injections). Severe complications will be defined as those which result in revision 
surgery, pain at rest, or impaired hand function at 12 month exam (i.e., severe CRPS 
type I or tendinitis and neuromas that do not improve with corticosteroid injections and 
require surgery). We will document patient return to work/activity at each follow-up 
appointment. 
 
Feasibility 
This study will assess the feasibility of recruiting patients into a prospective RCT and will 
obtain estimates to inform the sample size and design of a future adequately powered 
clinical trial. Specifically, we will be assessing randomization rate as calculated by 
dividing the number of patients randomized by the number of eligible participants and we 
will record the patient follow-up rate. In addition to our prospective study, we are 

 
 
 
 
 
 
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9 
currently performing a retrospective cohort study comparing patient-reported outcomes 
of patients who have undergone LRTI and IB over the past 2 years. We anticipate that 
this retrospective study will also be instrumental in informing the design and sample size 
of a definitive RCT. 
 
Potential Pitfalls/Alternative Strategies 
We are aware of several potential pitfalls which may present challenges to our study 
design, and we have developed alternative strategies to ensure that we achieve our 
aims in the event that these pitfalls occur. First, it is possible that patients will not 
consent to randomization into our trial at an acceptable rate. If, by 6 months into the 
enrollment period, we have not successfully randomized 25 patients, we are prepared to 
convert to a prospective cohort design. Second, it is possible that patients will not follow-
up at all time points. This has not been our experience with this population32; however, 
should this occur, we are prepared to have patients complete PROMIS questionnaires 
remotely and obtain all other data over the phone. 
D2 Subject Selection and Withdrawal  
 
2.a 
Inclusion Criteria  
The study population will consist of patients aged 50 years and older who are English-
speaking and community-dwelling. These patients will have a confirmed diagnosis of 
isolated thumb CMC arthritis. 
2.b 
Exclusion Criteria  
Patients will not have carpal tunnel syndrome (to avoid outcome data confusion), 
rheumatoid/inflammatory arthritis, or a history of chronic opioid use. 
2.c 
Subject Recruitment Plans and Consent Process 
The team will review patients’ medical records and radiographs to determine potential 
participants’ eligibility. The team will recruit eligible individuals during their clinic 
appointments using an information form outlining the benefits and relative limitations of 
each procedure. Patients who are interested in participating in the study will undergo 
initial testing at their clinic appointment, at which time they can also provide informed 
consent. 
2.d 
Randomization Method and Blinding 
The research team will block randomize the participants into a control group (LRTI) and 
a comparison group (IB); block sizes will be 4, 6, and 8. The study will not be blinded. 
2.e 
Risks and Benefits 
The main risks of this study are the risks of the surgical procedures themselves. These 
include pain, stiffness, infection, damage to surrounding structures (nerves, tendons, 
blood vessels), and the possibility that the surgery would not work and necessitate 
revision surgery. In addition to these, there may be other unknown risks, or risks that we 
did not anticipate, associated with being in this study. 
 

 
 
 
 
 
 
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10 
The patient will not benefit from being in this study. However, we hope that, in the future, 
other people might benefit from this study because we will obtain important information 
regarding surgery for thumb CMC OA. 
2.f 
Early Withdrawal of Subjects and When and How to Withdraw 
Subjects 
Patients may withdraw at any time by telling the study team they are no longer interested 
in participating in the study or you may send in a withdrawal letter. A sample withdrawal 
letter can be found at https://hrpo.wustl.edu/participants/withdrawing-from-a-study/ under 
Withdrawing from a Research Study. 
2.g 
Data Collection and Follow-up for Withdrawn Subjects  
In the event that a patient withdraws from the study, they will continue to follow-up at 
standard follow-up intervals as is practice for patients regardless of whether they 
participate in a study or not. PROMIS data will continue to be collected as is protocol for 
all patients presenting to Washington University clinics, but all other study-specific data 
will no longer be gathered. 
E Study Procedures  
 
E1 Screening for Eligibility 
The team will review patients’ medical records and radiographs to determine potential 
participants’ eligibility. The team will recruit eligible individuals during their clinic 
appointments using an information form outlining the benefits and relative limitations of 
each procedure. An initial screening REDCap data collection form has been developed 
and will be used to this end. 
E2 Schedule of Measurements, Visits, Safety and Adverse 
Events 
Patients will undergo the surgery to which they are randomized, either LRTI or IB, 
performed by one of the seven Washington University orthopaedic hand surgeons. All 
patients will follow-up in clinic 2 weeks, 4 weeks, 3 months, and 1 year post-operatively. 
 
PROMIS Physical Function and Upper Extremity scores will be collected at all clinic 
visits on iPad as per standard protocol for all patients presenting to a Washington 
University Orthopaedic Surgery clinic. Thumb ROM at carpometacarpal, 
metacarpophalangeal, and interphalangeal joints will be collected by a member of our 
team at 4 weeks, 3 months, and 1 year after surgery. Visual Analog Scale Pain and 
Satisfaction scores will be collected by a member of our team at 2 weeks, 4 weeks, 3 
months, and 1 year post-op. Grip and pinch strength (3-point and lateral vs contralateral 
values and vs preoperative values) will be collected at pre-op visit and all post-op visits 
except the 2 week visit. Radiographic subsidence will be measured via C-arm 
radiographs at 3 months and 1 year post-op. Complications (mild, moderate, severe) will 
be recorded throughout the course of the study at all time points. Mild complications will 
be defined as those with minor clinical impact (i.e., scar tenderness or sensory 
disturbances). Moderate complications will be defined as clinically relevant with delay in 
patient recovery, but not severe enough to necessitate revision surgery and resolve by 

 
 
 
 
 
 
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11 
12 months after surgery (i.e., mild CRPS type I, tendinitis, neuromas treated with steroid 
injections). Severe complications will be defined as those which result in revision 
surgery, pain at rest, or impaired hand function at 12 month exam (i.e., severe CRPS 
type I or tendinitis and neuromas that do not improve with corticosteroid injections and 
require surgery). We will document patient return to work/activity at each follow-up 
appointment. 
E3 Study Outcome Measurements and Ascertainment 
Study outcomes will be measured in clinic either on iPads (PROMIS) which is linked to 
our REDCap system, or entered into REDCap by the research coordinator or 
occupational therapists. 
F Statistical Plan  
 
F1  Sample Size Determination and Power 
Various methods are identified in the literature for formulating a pilot study sample size. 
Julious31 recommends a minimum sample size of 12 per group as a rule of thumb and 
justifies this based on rationale about feasibility and precision about the mean and 
variance. So as to align our study with these recommendations, we plan to enroll 50 
patients total in our pilot/feasibility study. 
 
Approximately 100 patients per year undergo surgical intervention (either IB or LRTI) for 
CMC OA at Washington University. Assuming a 50% randomization rate for this study, a 
sample size of 100 produces a two-sided 95% confidence interval with a lower limit of 
0.404 and upper limit of 0.596 when the sample proportion is 0.5. The primary goal of 
the trial is to assess feasibility and to obtain estimates for planning a larger, more 
definitive study to detect meaningful changes in clinical outcome measures. 
  
F2  Analysis Plan and Statistical Methods 
Patient demographic and clinical characteristics will be summarized using means 
(standard deviation, SD) or median (25th, 75th) for continuous variables and frequency 
(percentage) for categorical variables. The recruitment rate (95% confidence interval) 
will be reported as the number randomized out of the total number of participants 
approached to participate in the study (screened). Reasons for not wanting to participate 
will be summarized and reported. The effect sizes and variability of the PROMs for each 
group will be reported and used to determine the sample size for a larger definitive trial. 
Differences in PROMs between LRTI and IB at 6 weeks and 3 months will be examined 
using a two-sample t-test and differences in categorical outcomes (return to 
work/activity, yes/no, at 3 months) using Pearson chi-squared test. Changes over time 
will be evaluated graphically to see the trajectory of change over follow-up and for 
assessing critical time points to inform future study design parameters. Objective 
parameters will be summarized for each group using descriptive statistics.  The 
significance level will be 0.05 for all tests due to the exploratory nature of the study. 
 

 
 
 
 
 
 
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12 
G Data Handling and Record Keeping  
 
G1 Confidentiality and Security 
Only the minimum necessary private information is collected for the purposes of the 
study. Any procedures or interventions conducted as part of the study will be conducted 
in private setting to the extent possible. Recruitment/consent will occur in a private 
setting. Participants will be able to ask questions in a private setting. All materials are 
stored in secured environment and access is limited to research team members only. 
Our data will be stored in REDCap. 
 
H Study Administration 
 
H1 Organization and Participating Centers 
This study will be performed at Washington University/Barnes-Jewish Hospital. All 
patient encounters (clinic visits, surgeries) will take place at one of three sites within the 
Washington University Orthopaedics/Barnes-Jewish Hospital system. These sites are: 
Center for Advanced Medicine (St. Louis, MO), Center for Advanced Medicine – South 
County (St. Louis, MO), and Washington University/Barnes-Jewish Orthopaedic Center 
(Chesterfield, MO). 
H2 Funding Source and Conflicts of Interest 
An American Foundation for Surgery of the Hand Fast Track Grant ($5000) application 
was submitted for this study on 9/8/2019. Funding decisions will be announced in 
December 2019. The remainder of the study costs will be funded by the Washington 
University Department of Orthopaedic Surgery. 
H3 Subject Stipends or Payments  
Subjects will not receive compensation to participate in the study. 
H4  Study Timetable 
 
6 months 
12 months 
24 months 
Specific Aim 1 
Patient 
enrollment, 
surgeries, data 
collection 
Statistical analysis, 
manuscript writing and 
submission 
Dissemination of study 
findings, future definitive 
RCT planning and 
execution 
Specific Aim 2 
Patient 
enrollment, 
surgeries, data 
collection 
Statistical analysis, 
manuscript writing and 
submission 
Dissemination of study 
findings, future definitive 
RCT planning and 
execution 
Specific Aim 3 
Patient 
enrollment, 
surgeries, data 
collection 
Statistical analysis, 
manuscript writing and 
submission 
Dissemination of study 
findings, future definitive 
RCT planning and 
execution 
 

 
 
 
 
 
 
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13 
 
I Publication Plan  
 
We plan to publish our study’s findings in a major journal such as Journal of Bone and 
Joint Surgery or the Journal of Hand Surgery. 
 
J  Attachments  
 
J1  Informed consent documents 
Please refer to “Consent Documents & Other Attachments” section of IRB proposal for 
document entitled “LRTI IB Consent V1”. 
J2  Patient education brochures 
Please refer to “Consent Documents & Other Attachments” section of IRB proposal for 
document entitled “2 Surgical Ooptions for Base of the Thumb Arthritis”. 
K References 
 
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Haugen, I.K., et al., Prevalence, incidence and progression of hand osteoarthritis 
in the general population: the Framingham Osteoarthritis Study. Ann Rheum Dis, 
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2. 
Heyworth, B.E., et al., Hylan versus corticosteroid versus placebo for treatment 
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3. 
Zhang, Y., et al., Prevalence of symptomatic hand osteoarthritis and its impact on 
functional status among the elderly: The Framingham Study. Am J Epidemiol, 
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4. 
Burton, R.I. and V.D. Pellegrini, Jr., Surgical management of basal joint arthritis 
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5. 
Cebrian-Gomez, R., et al., Outcomes of cementless joint prosthesis versus 
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Eaton, 
R.G., 
et 
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reconstruction 
for 
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painful 
thumb 
carpometacarpal joint: a long-term assessment. J Hand Surg Am, 1984. 9(5): p. 
692-99. 
7. 
Gerwin, M., et al., Ligament reconstruction basal joint arthroplasty without tendon 
interposition. Clin Orthop Relat Res, 1997(342): p. 42-5. 
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Jorheim, M., et al., Short-term outcomes of trapeziometacarpal artelon implant 
compared with tendon suspension interposition arthroplasty for osteoarthritis: a 
matched cohort study. J Hand Surg Am, 2009. 34(8): p. 1381-7. 
9. 
Kriegs-Au, G., et al., Ligament reconstruction with or without tendon interposition 
to treat primary thumb carpometacarpal osteoarthritis. A prospective randomized 
study. J Bone Joint Surg Am, 2004. 86-A(2): p. 209-18. 

 
 
 
 
 
 
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14 
10. 
Lins, R.E., et al., Basal joint arthritis: trapeziectomy with ligament reconstruction 
and tendon interposition arthroplasty. J Hand Surg Am, 1996. 21(2): p. 202-9. 
11. 
Nylen, S., A. Johnson, and A.M. Rosenquist, Trapeziectomy and ligament 
reconstruction for osteoarthrosis of the base of the thumb. A prospective study of 
100 operations. J Hand Surg Br, 1993. 18(5): p. 616-9. 
12. 
Tomaino, M.M., V.D. Pellegrini, Jr., and R.I. Burton, Arthroplasty of the basal joint 
of the thumb. Long-term follow-up after ligament reconstruction with tendon 
interposition. J Bone Joint Surg Am, 1995. 77(3): p. 346-55. 
13. 
Acheson, R.M., Y.K. Chan, and A.R. Clemett, New Haven survey of joint 
diseases. XII. Distribution and symptoms of osteoarthrosis in the hands with 
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