CLINICAL RESEARCH GROUP |
Johns Hopkins at The Good Samaritan Hospital is actively involved in research
projects concerning the diagnosis and treatment of a number
of musculoskeletal diseases that affect the lower extremity
(hip and knee, in particular). The following is a summary of
these projects. Please be aware that participation in any of
these studies is strictly voluntary. If a patient does not choose
to participate in a study, it will not affect the quality of
care that he or she receives.
Factors Influencing the Outcome of Total Joint Arthroplasty
Rationale: To evaluate different patient-related factors which
may affect the outcome of total hip or knee replacement. These
factors include factors relating to 1) the patient such as disease,
gender, and weight; 2) the surgeon; and 3) the implant (e.g.
design and materials).
Candidates for Enrollment: All patients who have undergone or
are planning to undergo total joint surgery by one of the orthopaedic
surgeons of JHU Orthopaedics @ Good Samaritan Hospital.
Status: Open Enrollment. All patients who are seen in our office
and are planning total hip or knee replacement, or have had
surgery, are asked to participate in this project.
Duration of Study: Indefinite.
Do Corticosteroid-Associated Osteonecrosis Patients Develop
To evaluate whether patients with osteonecrosis of the hip (femoral
head) associated with a history of corticosteroid therapy develop
osteoporosis and, if so, if it is at a different rate than osteonecrosis
patients (hip) without a history of corticosteroid therapy.
Candidates for Enrollment: All patients who have been diagnosed
with osteonecrosis of the femoral head by a physician. You cannot
have had a previous surgery in the hip under study.
Status: Open Enrollment. All patients who are seen in our office
and have been diagnosed with osteonecrosis of the hip are eligible.
Duration of Study: Two visits.
STUDIES CONDUCTED IN PAST 5 YEARS
Citation Total Hip Study:
part of a multicenter study, we evaluated the clinical and radiographic
(x-ray) outcome of patients who underwent a total hip replacement
surgery with a Citation® total hip prosthesis. Twenty-five
patients ages 18-75 years old, underwent primary total hip replacement
using cementless femur. Patients were followed for five years.
Clinical and radiographic assessments were evaluated pre-operatively,
intra-operatively, prior to discharge, 6-12 weeks post-op, 6
months, 1 year, and 2 years and 5 years post-operatively.
Meridian Total Hip Study:
multicenter study evaluated the clinical and radiographic (x-ray)
outcome of patients who underwent a total hip replacement surgery
with a Meridian® total hip prosthesis. Twenty-seven patients
who had Meridian total hip replacement performed in 1995-1996
were evaluated. This is a chart review and long term follow-up
study. Patients were followed for five years.
Effectiveness of Revision Knee Arthroplasty Study:
number of patients undergoing total knee replacement has increased
as a result of a rise in the aging population and the benefits
of total joints. With the increase in total joints, there has
also been a need for more revision surgeries. This multicenter
study was designed to evaluate the outcomes of total knee revision.
Patients greater than 18 years of age who are undergoing revision
of the tibial and/or femoral component of a total knee replacement
were evaluated. Evaluations were conducted at baseline, in hospital,
first post-operative visit and 6 months post-operatively. This
study was a 2-phase study.
multicenter study evaluated the effectiveness of rhBMP-2 (an
absorbable collagen sponge) in core decompression surgery as
an aide to restoration of normal bone in patients with osteonecrosis.
Eight patients with Stage I or II osteonecrosis (ON) undergoing
core decompression surgery were candidates for this study. All
patients were followed for 3 years.
is a hormone that stimulates the production and release of red
blood cells. Procrit is a medication that has the same biological
effects as natural erythropoietin. Procrit has been shown in
prior studies to increase the production of red blood cells,
and when given to patients pre-operatively, was shown effective
in reducing the number of blood transfusions needed. This multicenter
study was designed to compare patients who receive Procrit in
2 weekly doses to patients who receive no Procrit prior to primary
total knee replacement. Due to difficulty meeting inclusion
criteria for this study, only 3 patients were enrolled prior
to discontinuing this trial.
Grafton® Demineralized Bone Matrix Gel Study
multicenter study evaluated the effectiveness of Grafton Gel
and hip core decompression compared to hip core decompression
alone. Patients with Stage II, Stage III, or Stage IV osteonecrosis
of the hip were candidates for participation. Enrolled patients
were followed until 2 years post-operatively.
Cosamin DS Study
aim of this study was to evaluate the effectiveness of the nutritional
supplement Cosamin DS (chondroitin sulfate and glucosamine)
in the treatment of osteoarthritis of the knee. Sixty-eight
patients 35-80 years of age with osteoarthritis of the knee
who have been symptomatic a minimum of 6 months and demonstrate
osteoarthritis on x-ray films were enrolled in this study. Patients
were followed for six months.
Fosamax (Alendronate) Study:
Osteolysis is a condition which causes loss of bone around a
total hip prosthesis in some patients. The purpose of this multicenter
study was to evaluate the use of FOSAMAX, a marketed drug used
in the treatment of osteoporosis and Paget's disease, for its
potential to decrease or stop osteolysis. Three patients were
enrolled in this study at this site.
Octocal F15 in Total Hip Replacement
patients were enrolled in a study where Octocal F15, a fibrin
glue which is a natural surgical adhesive was used to evaluate
its effectiveness in decreasing blood loss and the need for
transfusions after total hip replacement. This multicenter study
was completed with 6 month follow-up.
Octocal F15 PharmoEconomic Study
17 patients entered into the Octocal F15 hip study were consented
for further permission to review their medical billing records.
The purpose of this multicenter study was to evaluate the medical
cases for patients who received Octocal 15 compared to patients
who received the standard of care.
Bone mineral density changes occur around total hip replacements.
The use of standard x-rays for monitoring these changes is not
always considered satisfactory. This study was performed by
using a technique of dual energy x-ray absorptiometry (DEXA)
and assessing it's use as a more accurate tool than standard
Thirty-one patients were enrolled into this study, 4 patients
withdrew from the study and 27 patients were followed. Nine
patients completed all 6 scans required for 2 years, 10 patients
had 5 scans, 3 patients had 4 scans, 3 patients had 3 scans
and 2 patients had 2 scans done.
Ultram Pain Relief Study
study was a multicenter one in which patients were interviewed
9 times via telephone to assess the effectiveness of Ultram
as an analgesic for relief of pain. Eleven patients were enrolled
at this center.
UniSpacer Knee Arthroplasty Study:
was a multicenter study that evaluated the clinical and radiographic
(x-ray) outcome of patients who have had a UniSpacer knee arthroplasty
implanted. Thirty patients age 18 years or older undergoing
placement of a UniSpacer prosthesis were recruited. Two year
follow-up included clinical and radiopraphic assessments.
Synvisc Injections in Patients with Mild to Moderate Osteoarthritis
of the Hip Study:II. Ultram Pain Relief Study
multicenter study evaluated the effectiveness of Synvisc injections
in patients with mild to moderate osteoarthritis of the hip
as compared to the use of steroid injections. Patients age 35
years or older, with mild to moderate osteoarthritis as evaluated
by x-ray and degree of pain were eligible to participate. Six
month follow-up was obtained for all patients who enrolled in