University Orthopaedic Associates is Enrolling Patients for a New Hip Study
Primary Investigator: Stephen Kayiaros, MD, (732) 537-0909, firstname.lastname@example.org
IRB Study: Pro20140001090
TITLE OF STUDY:The Impact of Two Different Physical Therapy Programs in the Rehabilitation of Patients Undergoing Anterior Approach Hip Replacement Surgery.
Why is this study being done?
The study’s purpose is to investigate two types of physical therapy programs in the rehabilitation of patients who undergo a minimally invasive hip replacement surgery (anterior approach). This special type of surgery uses the top portion of the thigh for the incision rather than the back of the thigh (posterior approach). Multiple studies have shown that patients undergoing this specific type of hip replacement surgery (minimally invasive) require less intense rehabilitation because their muscles are damaged less by surgery. This study wants to compare physical therapist directed physical therapy with a self-directed physical therapy protocol to demonstrate that both types of therapy will equally return people to normal function after surgery.
Who may take part in this study? And who may not?
Patients between the ages of 18 to 80, who walk without help (canes, walkers), and those that will be going home directly from the hospital after surgery are eligible for this study. You may not enter the study if you meet any of the following:
- If you recently (<1 year) had a heart attack, stroke, or lung clots
- If you had previous invasive surgery on the hip undergoing replacement
- If you have dementia, Parkinson’s, or similar problems because that makes it more difficult to follow physical therapy programs and require special treatment/rehabilitation
- If you don’t walk. This study is looking at your ability to walk after hip replacement surgery.
- If you don’t have the ability to consent, whether because of mental illness or otherwise.
- If you are being discharged to a rehabilitation center. We won’t be able to monitor your post-operative therapy if you go to a rehab center.
- If you experience any complications during the surgery, such as a fracture of the leg bone. These complications change the postop therapy.
What will you be asked to do if you take part in this research study?
You will be randomly assigned to one of two physical therapy groups by chance. Neither you nor your doctor can choose the group you will be in. The two groups are:
1) self-directed physical therapy or
2) formal physical therapy.
The self-directed physical therapy group concentrates on a self-directed home therapy program, which will be supervised by Dr. Kayiaros and his physician assistant. This self-directed physical therapy group will perform daily exercises at home. You will be given instructions on how to perform these exercises at your pre-op visit as well as in the hospital after surgery. To assure that you are advancing appropriately, all patients will receive a phone call at two weeks post op from Dr. Kayiaros’ assistant to determine your progress prior to their regularly scheduled 1 month post op visit. If there is concern you are not progressing appropriately, Dr. Kayiaros will discuss with you the option of switching to formal therapy. This self-directed physical therapy group will continue to perform self-directed home therapy for the duration of the study. The second group will undergo standard outpatient physical therapy (formal physical therapy) for the duration of the study. Thus, if you are in the formal group, your process will be monitored by a trained physical therapist. Regardless of your group, you will be continuously monitored by clinical staff and/or physical therapists at all times. Participants in both groups will have an office visit at 1 month, 3 months, 6 months and 12 months after surgery, which is normal after hip replacement surgery. If more postoperative visits are deemed necessary depending on individual progress, these will be arranged. Upon each visit to the office you will be asked to complete self-administered questionnaires that address how you are functioning. These forms and scales are standardized tests used in research. The completion of these forms will take roughly 5-10 minutes. You will also complete a Timed Up and Go Test (TUG Test). The TUG test consists of timing you getting up from a chair, walking 10 feet, and then returning back to the chair. Your office visit will last as long as necessary for Dr. Kayiaros and his clinical staff to properly evaluate you, which is generally 10-20 minutes.
For more information about involvement with this study, please contact Dr. Kayiaros or his staff.
There is NO compensation for involvement in this study.
Dr. Kayiaros may be reached at (732) 537-0909, or at the University Orthopaedic Associates office:
2 Worlds Fair Drive
Somerset, NJ 08873
*This study has been approved by the Internal Review Board, Rutgers University Pro20140001090