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CompletedNCT04199390Updated Dec 13, 2019

Physical Therapy Following Total Hip Arthroplasty

An interventional study of total hip arthroplasty in Hip Osteoarthritis and Surgery, sponsored by Orthopedic One. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-12-13.

Sponsored by Orthopedic One · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Jul 2018, registered Dec 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hip Osteoarthritis
  • Surgery

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Keywords

  • total hip arthroplasty
  • physical therapy
03

In context

Osteoarthritis, Hip

628 studies on the registry are indexed under Osteoarthritis, Hip; 121 are open to participants now.

This study's enrollment of 130 is above the median of 90 across 450 interventional studies indexed under Osteoarthritis, Hip.

Browse Osteoarthritis, Hip studies →

Lead sponsor

This is the only study on the registry with Orthopedic One as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
130 participants (actual)

Study arms

  • Active comparator
    Clinic-based Physical Therapy

    Procedure: total hip arthroplasty

  • Active comparator
    Home-based Physical Therapy

    Procedure: total hip arthroplasty

Interventions

  • Proceduretotal hip arthroplasty

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

    Also known as: physical therapy

06

What researchers measure

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

07

Study locations

1 site
  • Orthopedic One
    Dublin, Ohio 43016, United States
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References and documents

Publications

  • Wolford ML, Palso K, Bercovitz A. Hospitalization for total hip replacement among inpatients aged 45 and over: United States, 2000-2010. NCHS Data Brief. 2015 Feb;(186):1-8. PubMed 25714040 ↗
  • Ong KL, Lotke PA, Lau E, Manley MT, Kurtz SM. Prevalence and Costs of Rehabilitation and Physical Therapy After Primary TJA. J Arthroplasty. 2015 Jul;30(7):1121-6. doi: 10.1016/j.arth.2015.02.030. Epub 2015 Feb 28. PubMed 25765130 ↗
  • Kramer JF, Speechley M, Bourne R, Rorabeck C, Vaz M. Comparison of clinic- and home-based rehabilitation programs after total knee arthroplasty. Clin Orthop Relat Res. 2003 May;(410):225-34. doi: 10.1097/01.blo.0000063600.67412.11. PubMed 12771834 ↗
  • Galea MP, Levinger P, Lythgo N, Cimoli C, Weller R, Tully E, McMeeken J, Westh R. A targeted home- and center-based exercise program for people after total hip replacement: a randomized clinical trial. Arch Phys Med Rehabil. 2008 Aug;89(8):1442-7. doi: 10.1016/j.apmr.2007.11.058. Epub 2008 Jun 30. PubMed 18586222 ↗
  • Di Monaco M, Vallero F, Tappero R, Cavanna A. Rehabilitation after total hip arthroplasty: a systematic review of controlled trials on physical exercise programs. Eur J Phys Rehabil Med. 2009 Sep;45(3):303-17. Epub 2009 Feb 23. PubMed 19238130 ↗
  • Berger RA, Jacobs JJ, Meneghini RM, Della Valle C, Paprosky W, Rosenberg AG. Rapid rehabilitation and recovery with minimally invasive total hip arthroplasty. Clin Orthop Relat Res. 2004 Dec;(429):239-47. doi: 10.1097/01.blo.0000150127.80647.80. PubMed 15577494 ↗
  • Sharma V, Morgan PM, Cheng EY. Factors influencing early rehabilitation after THA: a systematic review. Clin Orthop Relat Res. 2009 Jun;467(6):1400-11. doi: 10.1007/s11999-009-0750-9. Epub 2009 Mar 10. PubMed 19277807 ↗
  • Austin MS, Urbani BT, Fleischman AN, Fernando ND, Purtill JJ, Hozack WJ, Parvizi J, Rothman RH. Formal Physical Therapy After Total Hip Arthroplasty Is Not Required: A Randomized Controlled Trial. J Bone Joint Surg Am. 2017 Apr 19;99(8):648-655. doi: 10.2106/JBJS.16.00674. PubMed 28419032 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04199390
Lead sponsor
Orthopedic One
Collaborators
Medacta USA
Responsible party
Thomas J Ellis (Principal Investigator, Orthopedic One) — Principal investigator
First posted
Dec 13, 2019
Start date
Jul 31, 2018
Primary completion
Oct 7, 2019
Completion
Oct 7, 2019
Last update
Dec 13, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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