Back to resultsThe Impact of Two Different Physical Therapy Programs in the Rehabilitation of Patients Undergoing Anterior Approach Hip Replacement Surgery
Primary Purpose
Hip Arthritis, Total Hip Arthroplasty
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Formal Physical Therapy
Self-directed Physical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Hip Arthritis focused on measuring Total Hip Arthroplasty, Anterior Approach, Physical Therapy
Eligibility Criteria
Inclusion Criteria:
- Patients aged between 18 and 80 years of age
- Patients undergoing primary anterior total hip arthroplasty for the diagnosis of osteoarthritis
- Patients with no previous invasive hip surgery (such as a previous hip replacement)
Exclusion Criteria:
- Non-English speaking persons will be excluded in our study.
- Patients with a recent history (<1 year) of heart attack, stroke, and lung clots.
- Previous invasive surgery on the hip undergoing replacement
- Patients with dementia, Parkinson's, or other neurological disorders
- Non-ambulatory patients
- Patients with impaired ability to consent, whether because of mental illness or otherwise
- Patients being discharged to a rehabilitation center
- Patients that experience intra-operative complications
Sites / Locations
- University Orthopaedic AssociatesRecruiting
- Robert Wood Johnson Somerset HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Formal Physical Therapy
Self-directed Physical Therapy
Arm Description
Outcomes
Primary Outcome Measures
Change inHarris Hip Score (HHS)
elf-administered health survey that assesses pain, function, absence of deformity, and range of motion of the hip through 10 questions. HHS measures dysfunction, so a higher score indicates a better, higher functional outcome. Less than 70 is poor result, 70-80 ia fair result, 80-90 is good result, 90-100 is excellent result
Secondary Outcome Measures
Change in timed up and go test
Patients will be assessed the amount of time it takes for them rise from a standard arm chair, walk 10 feet on the floor at normal pace, and then return and site down in same standard arm chair. Duration to complete task will be recorded in seconds
Change in Visual Analog Scale for Pain
Patients will rate their pain on a scale form 0-10 at a given time point with 0 being no pain and 10 being unbearable pain. The higher the number, the more pain
Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) form
Self-administered health survey that assesses pain, stiffness, and function of arthritis of the hip or knee. WOMAC form assesses activities of daily living, functional mobility, gait, general health, pain, and quality of life. WOMAC questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). A total score of 0 to 96 is possible, with a lower score indicating less pain or disability.
Full Information
NCT ID
NCT04492462
First Posted
June 29, 2020
Last Updated
September 14, 2021
Sponsor
Rutgers, The State University of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT04492462
Brief Title
The Impact of Two Different Physical Therapy Programs in the Rehabilitation of Patients Undergoing Anterior Approach Hip Replacement Surgery
Official Title
The Impact of Two Different Physical Therapy Programs in the Rehabilitation of Patients Undergoing Anterior Approach Hip Replacement Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 22, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will look to determine two different types of physical therapy regimens in patients who undergo anterior total hip replacement. We will compare the results of two groups. The first group, the "Formal Physical Therapy" group, will undergo standard physical therapy following their surgery. They will see a physical therapist in a physical therapy office after their surgery. Here, the therapist will work with the patient to strengthen muscles and improve their walking. The second group, the "Self-directed Physical Therapy" group, will undergo physical therapy in the comfort of their own home using common household items (chairs, steps, etc). These patients will be given a list of exercises and stretches to perform on their own. It is our goal to prove that formal physical therapy is not needed after anterior hip replacements.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Arthritis, Total Hip Arthroplasty
Keywords
Total Hip Arthroplasty, Anterior Approach, Physical Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Formal Physical Therapy
Arm Type
Experimental
Arm Title
Self-directed Physical Therapy
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Formal Physical Therapy
Intervention Description
Patients will undergo standard physical therapy following their surgery with a physical therapist in an office
Intervention Type
Other
Intervention Name(s)
Self-directed Physical Therapy
Intervention Description
Patients will undergo self-directed physical therapy in the comfort of their own home by completing a list of exercises and stretches without the direct supervision of a physical therapist in a physical therapist office
Primary Outcome Measure Information:
Title
Change inHarris Hip Score (HHS)
Description
elf-administered health survey that assesses pain, function, absence of deformity, and range of motion of the hip through 10 questions. HHS measures dysfunction, so a higher score indicates a better, higher functional outcome. Less than 70 is poor result, 70-80 ia fair result, 80-90 is good result, 90-100 is excellent result
Time Frame
assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery
Secondary Outcome Measure Information:
Title
Change in timed up and go test
Description
Patients will be assessed the amount of time it takes for them rise from a standard arm chair, walk 10 feet on the floor at normal pace, and then return and site down in same standard arm chair. Duration to complete task will be recorded in seconds
Time Frame
assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery
Title
Change in Visual Analog Scale for Pain
Description
Patients will rate their pain on a scale form 0-10 at a given time point with 0 being no pain and 10 being unbearable pain. The higher the number, the more pain
Time Frame
assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery
Title
Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) form
Description
Self-administered health survey that assesses pain, stiffness, and function of arthritis of the hip or knee. WOMAC form assesses activities of daily living, functional mobility, gait, general health, pain, and quality of life. WOMAC questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). A total score of 0 to 96 is possible, with a lower score indicating less pain or disability.
Time Frame
assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients aged between 18 and 80 years of age
Patients undergoing primary anterior total hip arthroplasty for the diagnosis of osteoarthritis
Patients with no previous invasive hip surgery (such as a previous hip replacement)
Exclusion Criteria:
Non-English speaking persons will be excluded in our study.
Patients with a recent history (<1 year) of heart attack, stroke, and lung clots.
Previous invasive surgery on the hip undergoing replacement
Patients with dementia, Parkinson's, or other neurological disorders
Non-ambulatory patients
Patients with impaired ability to consent, whether because of mental illness or otherwise
Patients being discharged to a rehabilitation center
Patients that experience intra-operative complications
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel C Mascarenhas, MD
Phone
732-235-7869
Email
daniel.mascarenhas@rutgers.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen T Kayiaros, MD
Organizational Affiliation
Rutgers University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Orthopaedic Associates
City
Somerset
State/Province
New Jersey
ZIP/Postal Code
08873
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Kayiaros, MD
Phone
732-537-0909
First Name & Middle Initial & Last Name & Degree
Stephen Kayiaros, MD
Facility Name
Robert Wood Johnson Somerset Hospital
City
Somerville
State/Province
New Jersey
ZIP/Postal Code
08876
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel C Mascarenhas, MD
Phone
732-235-7869
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
The Impact of Two Different Physical Therapy Programs in the Rehabilitation of Patients Undergoing Anterior Approach Hip Replacement Surgery
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