The Impact of Two Different Physical Therapy Programs in the Rehabilitation of Patients Undergoing Anterior Approach Hip Replacement Surgery

Total Hip Arthroplasty Clinical Trial

Official title:

The Impact of Two Different Physical Therapy Programs in the Rehabilitation of Patients Undergoing Anterior Approach Hip Replacement Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04492462
• Other study ID #: Pro20140001090
• Status: Recruiting
• Phase: N/A
• Start date: October 22, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2021
• Source: Rutgers, The State University of New Jersey
• Contact: Daniel C Mascarenhas, MD
• Phone: 732-235-7869
• Email: daniel.mascarenhas[@]rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Hip Arthritis
• Total Hip Arthroplasty

Intervention

Other:
• Formal Physical Therapy
Patients will undergo standard physical therapy following their surgery with a physical therapist in an office
• Self-directed Physical Therapy
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

Locations

Country	Name	City	State
United States	University Orthopaedic Associates	Somerset	New Jersey
United States	Robert Wood Johnson Somerset Hospital	Somerville	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery
Secondary	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	assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery
Secondary	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	assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery
Secondary	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.	assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery