Physical Therapy Following Total Hip Arthroplasty

NCT ID: NCT04199390

Last Updated: 2019-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-31

Study Completion Date

2019-10-07

Brief Summary

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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.

Detailed Description

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Conditions

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Hip Osteoarthritis Surgery

Keywords

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total hip arthroplasty physical therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Clinic-based Physical Therapy

Group Type ACTIVE_COMPARATOR

total hip arthroplasty

Intervention Type PROCEDURE

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

Home-based Physical Therapy

Group Type ACTIVE_COMPARATOR

total hip arthroplasty

Intervention Type PROCEDURE

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

Interventions

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total hip arthroplasty

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

Intervention Type PROCEDURE

Other Intervention Names

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physical therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medacta USA

INDUSTRY

Sponsor Role collaborator

Orthopedic One

OTHER

Sponsor Role lead

Responsible Party

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Thomas J Ellis

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Orthopedic One

Dublin, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 25714040 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25765130 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12771834 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18586222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19238130 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15577494 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19277807 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28419032 (View on PubMed)

Other Identifiers

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20181607

Identifier Type: -

Identifier Source: org_study_id