Physical Therapy Following Total Hip Arthroplasty

December 12, 2019 updated by: Thomas J Ellis, Orthopedic One

Randomized Controlled Trial of Home-based Physical Therapy Versus Outpatient Clinic-based Physical Therapy Following Primary Anterior Total Hip Arthroplasty

130 patients undergoing primary unilateral total hip arthroplasty through anterior approach were enrolled and randomized into one of two groups. One group received standard of care clinic-based physical therapy postoperatively (clinic PT) while the other group underwent progressive home-based exercises to do after surgery (home PT). Patient surveys with Hip Osteoarthritis Outcome Scores (HOOS) and SF12v2 scores for both groups were obtained before surgery as well as 6, 14, and 24 weeks postop. Patients had the option to crossover into the other study group at their 6-week follow-up visit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • 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 Locations

  • United States
    • Ohio
      • Dublin, Ohio, United States, 43016
        • Orthopedic One

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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • scheduled to undergo primary unilateral anterior total hip arthroplasty for the treatment of arthritis under the care of the Principal investigator
  • available for follow ups postoperatively

Exclusion Criteria:

  • Age <18 or > 75
  • Preoperative BMI ≥ 40
  • Revision (i.e., non-primary) THA procedures
  • Patients who have undergone THA in contralateral hip within the past 6 months
  • Patient is scheduled for or anticipating THA on contralateral limb within 6 months
  • Patients with an active infection (at the time of screening through surgery, as this is a surgical contraindication)
  • Current co-morbidities such as alcohol or drug addiction, and/or mental disorders could potentially interfere with study participation
  • Cognitive deficit or significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting
  • History of severe osteoporosis, metabolic bone disease, radioactive bone disease, or tumor in the bone surrounding the hip joint
  • History of significant neurological and/or musculoskeletal disorders that may adversely affect gait after THA
  • History of inflammatory hip arthritis
  • History of septic hip arthritis in affected hip
  • Patients requiring discharge to a rehabilitation center, skilled nursing facility, long-term care center, or convalescent home
  • Non-English speaking
  • Unable to give informed consent
  • Currently enrolled in another therapeutic study for THA

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Clinic-based Physical Therapy
Procedure: total hip arthroplasty
each patient is expected to undergo an anterior total hip arthroplasty procedure and some sort of physical therapy postoperatively
Other Names:
  • physical therapy
Active Comparator: Home-based Physical Therapy
Procedure: total hip arthroplasty
each patient is expected to undergo an anterior total hip arthroplasty procedure and some sort of physical therapy postoperatively
Other Names:
  • physical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Hip Disability and Osteoarthritis Outcome Scores
Time Frame: preoperative, postoperative 6 weeks, postoperative 12 weeks, and postoperative 24 weeks
preoperative, postoperative 6 weeks, postoperative 12 weeks, and postoperative 24 weeks
Change in SF-12v2 Scores
Time Frame: preoperative and postoperative 24 weeks
preoperative and postoperative 24 weeks

Collaborators and Investigators

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

Sponsor

Orthopedic One

Collaborators

Medacta USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 31, 2018

Primary Completion (Actual)

October 7, 2019

Study Completion (Actual)

October 7, 2019

Study Registration Dates

First Submitted

December 10, 2019

First Submitted That Met QC Criteria

December 12, 2019

First Posted (Actual)

December 13, 2019

Study Record Updates

Last Update Posted (Actual)

December 13, 2019

Last Update Submitted That Met QC Criteria

December 12, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20181607

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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