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OpenTrials
Completed

NCT Number: NCT04199390

Physical Therapy Following 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopedic One

Dublin, Ohio, 43016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total Hip Arthroplasty

Procedure

each patient is expected to undergo an anterior total hip arthroplasty procedure and some sort of physical therapy postoperatively

Other names: physical therapy

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Orthopedic One

Other

Collaborators

  • Medacta USA

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 13, 2019
Registry last updated
Dec 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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