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Physical Therapy Following Total Hip Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04199390
Recruitment Status : Completed
First Posted : December 13, 2019
Last Update Posted : December 13, 2019
Sponsor:
Collaborator:
Medacta USA
Information provided by (Responsible Party):
Thomas J Ellis, Orthopedic One

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hip Osteoarthritis Surgery Procedure: total hip arthroplasty Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Home-based Physical Therapy Versus Outpatient Clinic-based Physical Therapy Following Primary Anterior Total Hip Arthroplasty
Actual Study Start Date : July 31, 2018
Actual Primary Completion Date : October 7, 2019
Actual Study Completion Date : October 7, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: physical therapy




Primary Outcome Measures :
  1. Change in Hip Disability and Osteoarthritis Outcome Scores [ Time Frame: preoperative, postoperative 6 weeks, postoperative 12 weeks, and postoperative 24 weeks ]
  2. Change in SF-12v2 Scores [ Time Frame: preoperative and postoperative 24 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04199390


Locations
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United States, Ohio
Orthopedic One
Dublin, Ohio, United States, 43016
Sponsors and Collaborators
Orthopedic One
Medacta USA
Publications:

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Responsible Party: Thomas J Ellis, Principal Investigator, Orthopedic One
ClinicalTrials.gov Identifier: NCT04199390    
Other Study ID Numbers: 20181607
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas J Ellis, Orthopedic One:
total hip arthroplasty
physical therapy
Additional relevant MeSH terms:
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Osteoarthritis, Hip
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases