Research

A Pilot Study of a Dexamethasone Implant System in Humans

IRB Number:

Institutional Review Board, Hospital for Special Surgery

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Mark P. Figgie, MD

Co-Investigators

Ryan Sutherland

Summary

The purpose of this study is to assess safety and implant tolerability of an extended release dexamethasone insert in patients who are eligible to receive a total knee replacement due to osteoarthritis (OA) of the knee but desire to delay the surgery. Dexamethasone is a type of steroid used to treat inflammatory conditions such as your knee arthritis. Your overall participation will continue over the course of 6 months.

Six patients will be enrolled based on a screening visit. The dexamethasone insert will be placed in the “safe zone” of the knee during the day of implantation, and the subject will be followed via office visits at weeks 4, 12, and 24. After 24 weeks the implant will remain in the knee until a total knee replacement is performed.

Your participation will involve a total of 5 study visits.  The length of each visit will vary, as shown below:

Study Visit                                            Length of Visit

Screening Visit                                   1.5 hours (includes blood draw and X-rays)

Day of Implantation                            3 hours

Week 4: Follow-up Office Visit           1.5 hours (includes blood draw and X-rays)

Week 12: Follow-up Office Visit         1 hour (includes blood draw)

Week 24:  Follow-up Office Visit        1.5 hours (includes blood draw and X-rays)


Enrollment period = 2 years

Inclusion/Exclusion Criteria

Inclusion Criteria

•  Male or female >= 40 years of age at time of consent

•  Diagnosis of unilateral or bilateral knee osteoarthritis for at least 6 months prior to screening with confirmation of osteoarthritis according to the American College of Rheumatology Criteria for Classification of Idiopathic Osteoarthritis of the Knee (clinical and radiological) based on an X-ray performed within 6 months prior to screening or during the screening period

•  Kellgren – Lawrence grade ≥2 on weight bearing anteroposterior femorotibial radiograph performed within 6 months prior to or during screening period

•  During the office visit to determine eligibility for the study, the patient will be given a survey to provide pain scores at rest, at night, and during activity (0 – 10 Numeric Rating System). A mean of these scores ≥ 5 and ≤ 10 will be used as the inclusion criterion.

•  Body mass index (BMI) ≤ 40 kg/m2

•  Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions

 

Exclusion Criteria

•  Fibromyalgia, chronic pain syndrome, or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee

•  History of inflammatory arthritis including rheumatoid arthritis, juvenile inflammatory arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, reactive arthritis

•  Hemophilia

•  Achondroplasia

•  History of infection in the index joint

•  Intra-articular corticosteroid (investigational or marketed) in any joint within three months of screening

•  Intra-articular hyaluronic acid (investigational or marketed) in the index knee within three months of screening

•  Oral, inhaled, and intranasal corticosteroids (investigational or marketed) within one month of screening

•  Prior arthroscopic or open surgery of the index knee within 12 months of screening

•  Planned / anticipated surgery of the index knee during the study period

•  Active or history of malignancy within the last five years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ

•  Insulin dependent diabetes

•  History of or active Cushing’s syndrome

•  Skin breakdown at index knee where procedure would take place

•  Women of child-bearing potential

•  Case history related to motor vehicle accident or workers compensation

•  Presence of hardware in the index knee (e.g. screws, plates)

•  Immunocompromised patients (TB, HIV, etc.)

•  Allergic reactions to acetaminophen or paracetmol (e.g. Tylenol)

Contact Information

Ryan Sutherland
sutherlandry@hss.edu
646.797.8473