Trapezio-metacarpal Arthroplasty: Comparison of ARPE Prosthesis With the Literature.
Conditions: Arthritis
Sponsor: Zimmer Biomet

Clinical Research Protocol 
Study: Arpe prospective study 
Version 1.0 dd 12 Nov 2012 
 
 
 
 
 
 
 
 
Trapezio – metacarpal arthroplasty: 
comparison of ARPE® prosthesis with the literature 
 
PROTOCOL NUMBER (Study ID): ORTHO.CR.E16 
 
 
 
 
PROTOCOL VERSION: V1.0 dd 12 Nov 2012 
 
 
 
 
GENERAL INFORMATION 
 
 
 
 
Study Sponsor: BIOMET Global Supply Chain Center B.V. 
Toermalijnring 600 
3316 LC Dordrecht 
The Netherlands 

Clinical Research Protocol 
Study: Arpe prospective study 
Version 1.0 dd 12 Nov 2012 
 
 
 
 
TITLE 
Trapezio-metarcarpal arthroplasty: a comparison of ARPE 
prosthesis with the literature 
SHORT TITLE 
Arpe prospective study 
DESIGN 
Non-controlled, prospective cohort study in single centre 
STUDY 
DURATION 
2013- 2020 
STUDY CENTRE 
Single centre in Belgium 
POPULATION 
Inclusion of 100 subjects at single centre 
PRIMARY 
Research 
objectives 
The primary objective is to compare functional outcome at 3 
years after trapezio-metarcarpal arthroplasty with trapeziectomy 
and trapeziectomy with ligament reconstruction and tendon 
interposition. Literature values obtained by a recently published 
meta analysis1 will be used. 
SECONDARY 
Research 
Objectives 
Secondary objectives are: 
- to compare functional outcome at 1 and at 5 years after 
trapezio-metarcarpal arthroplasty with trapeziectomy and 
trapeziectomy with ligament reconstruction and tendon 
interposition 
- to determine pre- and postop HR QOL 
- Incidence of RLL at each f/up time point. 
Literature values from the same meta analysis1 will be used. 
OUTCOME 
Measures 
Patients will be assessed at preoperatively, and at 1, 3 and 5 
years postoperatively. Outcomes as described by Li et al1 will  
be measured: grip strength, tip pinch strength, key pinch 
strength, pain, occurrence of adverse events, hand function. 
Follow-up time 
Patients will be part of a longitudinal follow-up program with 
follow-ups at 1, 3, 5 years. 
Enrollment time 
2 Years 

Clinical Research Protocol 
Study: Arpe prospective study 
Version 1.0 dd 12 Nov 2012 
 
 
 
 
STATISTICS 
 
 
SAMPLE SIZE CALCULATION 
Based on a publication from Davis et al2 we expect the standard deviation in the study population 
for key pinch, tip pinch, and grip strength to be 0.82, 1.65 and 10.3, respectively. Setting alpha at 
0.05 and beta at 0.10, and assuming a MIREDIF (Minimally Relevant Difference) of 0.5 x 
Standard Deviation, an attrition rate of 10%, and data to be approximately normally distributed, 
the required sample size will be 96 (≈ 100) subjects. 
 
STATISTICAL PROTOCOL 
Continuous variables (e.g. age) will be summarized using the mean and standard deviation (SD). If 
the distribution of measurements is asymmetrical, the median and the interquartile range will be 
provided. For ordinal and nominal data proportions should be employed. Inferential statistics will 
be based on the unpaired t-test, or the Mann-Whitney test, depending on normality of the data. 
 
REFERENCES 
 
1.  
LI YK, WHITE C, IGNACY TA, THOMA A. COMPARISON OF TRAPEZIECTOMY AND 
TRAPEZIECTOMY WITH LIGAMENT RECONSTRUCTION AND TENDON INTERPOSITION: A 
SYSTEMATIC LITERATURE REVIEW. PLASTIC AND RECONSTRUCTIVE SURGERY. 2011 
JUL;128(1):199-207. PUBMED PMID: 2139956 
2.  
DAVIS TR, PACE A. TRAPEZIECTOMY FOR TRAPEZIOMETACARPAL JOINT OSTEOARTHRITIS: 
IS LIGAMENT RECONSTRUCTION AND TEMPORARY STABILISATION OF THE 
PSEUDARTHROSIS WITH A KIRSCHNER WIRE IMPORTANT? THE JOURNAL OF HAND 
SURGERY, EUROPEAN VOLUME. 2009 JUN;34(3):312-21. PUBMED PMID: 19321528.