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

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.

Study Overview

• Status: Recruiting
• Conditions: Total Hip Arthroplasty; Hip Arthritis
• Intervention / Treatment: Other: Formal Physical Therapy; Other: Self-directed Physical Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel C Mascarenhas, MD; Phone Number: 732-235-7869; Email: daniel.mascarenhas@rutgers.edu

Study Locations

• United States
  • New Jersey
    • Somerset, New Jersey, United States, 08873
      • Recruiting
      • University Orthopaedic Associates
      • Contact: Stephen Kayiaros, MD; Phone Number: 732-537-0909
    • Somerville, New Jersey, United States, 08876
      • Recruiting
      • Robert Wood Johnson Somerset Hospital
      • Contact: Daniel C Mascarenhas, MD; Phone Number: 732-235-7869

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Formal Physical Therapy	Other: Formal Physical Therapy; Patients will undergo standard physical therapy following their surgery with a physical therapist in an office
Experimental: Self-directed Physical Therapy	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Stephen T Kayiaros, MD, Rutgers University

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (Actual): July 30, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Physical Therapy; Total Hip Arthroplasty; Anterior Approach
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: Pro20140001090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No