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

NCT04492462 | Unknown

• 1 other identifier: Pro20140001090
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Hip Arthritis; Total Hip Arthroplasty

Keywords

Total Hip Arthroplasty; Anterior Approach; Physical Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in timed up and go test

  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

  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

  assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery

Study Arms (2)

Formal Physical Therapy

EXPERIMENTAL

Other: Formal Physical Therapy

Self-directed Physical Therapy

EXPERIMENTAL

Other: Self-directed Physical Therapy

Interventions

Formal Physical Therapy OTHER

Patients will undergo standard physical therapy following their surgery with a physical therapist in an office

Formal Physical Therapy

Self-directed Physical Therapy OTHER

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

Self-directed Physical Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (2)

University Orthopaedic Associates

Somerset, New Jersey, 08873, United States

RECRUITING

Robert Wood Johnson Somerset Hospital

Somerville, New Jersey, 08876, United States

RECRUITING

Study Officials

• Stephen T Kayiaros, MD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel C Mascarenhas, MD

CONTACT

732-235-7869; daniel.mascarenhas@rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Assistant Professor

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 30, 2020
• Study Start: October 22, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

US (2)