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Orthopaedics

Industry Sponsored Research

The Department of Orthopedics at Tufts Medical Center in Boston is engaged in a number of industry-sponsored research projects, including: 

Prospective Functional Outcome Study of the Knee (PFOSK)
Sponsor: Conformis
Research Team: Eric L. Smith, MD (Primary Investigator), Lauren Cipriani, (Co-Investigator), Mary Pevear (Study Coordinator), Adam Paggi, Physical Therapist (Co-I) Lucas Leggere, Physical Therapist (Co-I) Anna Jorgensen (Med student), Adam Roy (Med student)

The purpose of this study is to determine the best methods for evaluating functional outcomes of a total knee arthroplasty. There are many outcome tests used in Orthopaedics, but very few assess an individual’s recovery in balance, endurance, and strength all of which are needed for basic activities of daily living. This research will determine which tests accurately represent both clinical and patient-satisfaction outcomes. Working collaboratively with Conformis and a physical therapy team here at Tufts Medical Center, we will enroll 20 primary total knee arthroplasty patients. Subjects will be asked to perform a series of functional outcome measurments in addition to 3 standardized orthopaedic surveys preoperatively and then again at 6-weeks, 6-months and 1-year postoperatively. The results of this study will inform the design of a multicenter, randomized, industry sponsored trial.

LFIT™ Antomic CoCr  Femoral Heads with X3™ Polyethylene Insert
Research Team: Eric Smith, MD (Primary Investigator) Lauren Cipriani, PA-C (Co-Investigator),   Mary Pevear (SC)

The purpose of this open label, postmarket multi-center evaluation is to  study, sponsored by Stryker Orthopaedics is to evaluate the LFIT Anatomic CoCr Femoral Heads with X3 Inserts.a large size (36mm, 40mm or 44mm) femoral head called the LFIT™ Anatomic CoCr Femoral Head. The large size femoral heads will be used with the Trident® X3® polyethylene (plastic) inserts. The head and insert are mating parts of an artificial hip joint. 

Triathlon TS Outcomes Study: A prospective, post market, multi-center study of the outcomes of the Traithlon TS Total Knee System
Research Team: Eric Smith, MD (Primary Investigator) Lauren Cipriani, Physician’s Assistant (Co-Investigator), Mary Pevear (Study Coordinator)

This is a prospective, post market, multi-center study of the outcomes of the Traithlon TS Total Knee System. This system is used when a previous knee replacement surgery has failed. The Triathlon TS Total Knee System includes modular components that attach to your femur (thigh bone) and tibia (shin bone) separated by a tibial insert made of high quality plastic. It includes components that may be used as needed to substitute for any areas of bone loss to provide a stable, balanced total knee replacement. A total of approximately 181 subjects from 7-12 different clinics will be participating in this study. Approximately 30 subjects will be enrolled at Tufts Medical Center for this study. Learn more >

DePuy Post-Approval Study for the Ceramax Ceramic-on-Ceramic Acetabular Cup Prosthesis System (28mm)
Sponsor: DePuy
Research Team: Eric L. Smith (Primary Investigator), Lauren Cipriani (Co-Investigator), Mary Pevear (Study Coordinator)

The purpose of this study is to gather more clinical and radiographic information about the recently-approved 28mm ceramic-on-ceramic Ceramax™ hip implant system to see how it performs over a longer period of time. During a previous clinical study, the Ceramax™ implant was implanted in 168 subjects who were followed for a period of years. The FDA reviewed the clinical results and approved the implants for use in the United States. Some of those subjects will also continue follow up by taking part in a separate post-approval study. The Ceramax™ hip implant, developed by DePuy Orthopaedics, Inc., a Johnson & Johnson company, will be used in this study. It has a ceramic ball and a titanium socket (shell). Inside the socket there is a ceramic socket insert. This ceramic socket insert is the main difference between this hip implant and other marketed total hip replacement implants.

Post-Approval Study for the Ceramax Ceramic-on-Ceramic Acetabular Cup Prosthesis System (36mm)
Sponsor: DePuy
Research Team: Eric L. Smith (Primary Investigator), Lauren Cipriani (Co-Investigator), Mary Pevear (Study Coordinator)

The purpose of this study is to gather more clinical and radiographic information about the recently-approved 36mm ceramic-on-ceramic Ceramax™ hip implant system to see how it performs over a longer period of time.The compiled information will be included in the annual post-approval study reports. While most total hip replacements use a metal or ceramic “ball” attached to a metal stem and a metal socket with a plastic socket insert. The Ceramax™ hip implant, developed by DePuy Orthopaedics, Inc., a Johnson & Johnson company, used in this study has a ceramic ball and a titanium socket (shell). Inside the socket there is a ceramic socket insert. This ceramic socket insert is the main difference between this hip implant and other marketed total hip replacement implants.

Acquisition of Human Skeletal Tissue with Associated Blood Samples
Research Team: Eric Smith, MD (Primary Investigator) Lauren Cipriani, PA-C (Co-Investigator), Mary Pevear (SC)

The purpose of this study sponsored by Pfizer is to obtain and analyze species from human skeletal muscle tissues. Studies will advance our understanding of the regulation of these species in relation to the rate of lipolysis in adipose tissue.