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| 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.

CURRENT CLINICAL STUDIES

I. Factors Influencing the Outcome of Total Joint Arthroplasty Study:

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.

II. Do Corticosteroid-Associated Osteonecrosis Patients Develop Osteonecrosis?

Rationale: 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.

CLINICAL STUDIES CONDUCTED IN PAST 5 YEARS

I. Citation Total Hip Study:

As 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.

II. Meridian Total Hip Study:

Another 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.

III. Effectiveness of Revision Knee Arthroplasty Study:

The 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.

IV. rhBMP2 Study.

This 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.

V. Procrit Study

Erythropoietin 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.

VI. Grafton® Demineralized Bone Matrix Gel Study

This 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.

VII. Cosamin DS Study

The 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.

VIII. 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.

IX. Octocal F15 in Total Hip Replacement

Seventeen 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.

X. Octocal F15 PharmoEconomic Study

The 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.

XI. DEXA Study

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 x-rays.
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.

XII. Ultram Pain Relief Study

This 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.

XIII. UniSpacer Knee Arthroplasty Study:

This 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.

XIV. Synvisc Injections in Patients with Mild to Moderate Osteoarthritis of the Hip Study:II. Ultram Pain Relief Study

This 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 study.