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

September 14, 2021 updated by: Stephen Kayiaros MD, Rutgers, The State University of New Jersey
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change inHarris Hip Score (HHS)
Time Frame: assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in timed up and go test
Time Frame: assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery
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
Time Frame: assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery
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
Time Frame: assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rutgers, The State University of New Jersey

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stephen T Kayiaros, MD, Rutgers University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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