NCT04199390

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 31, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2019

Completed
Last Updated

December 13, 2019

Status Verified

December 1, 2019

Enrollment Period

1.2 years

First QC Date

December 10, 2019

Last Update Submit

December 12, 2019

Conditions

Hip OsteoarthritisSurgery

Keywords

total hip arthroplastyphysical therapy

Outcome Measures

Primary Outcomes (2)

  • Change in Hip Disability and Osteoarthritis Outcome Scores

    preoperative, postoperative 6 weeks, postoperative 12 weeks, and postoperative 24 weeks

  • Change in SF-12v2 Scores

    preoperative and postoperative 24 weeks

Study Arms (2)

Clinic-based Physical Therapy

ACTIVE COMPARATOR
Procedure: total hip arthroplasty

Home-based Physical Therapy

ACTIVE COMPARATOR
Procedure: total hip arthroplasty

Interventions

total hip arthroplastyPROCEDURE

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

Also known as: physical therapy
Clinic-based Physical TherapyHome-based Physical Therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopedic One

Dublin, Ohio, 43016, United States

Location

Related Publications (8)

  • 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.

    PMID: 25714040BACKGROUND

  • 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.

    PMID: 25765130BACKGROUND

  • 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.

    PMID: 12771834BACKGROUND

  • 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.

    PMID: 18586222BACKGROUND

  • 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.

    PMID: 19238130BACKGROUND

  • 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.

    PMID: 15577494BACKGROUND

  • 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.

    PMID: 19277807BACKGROUND

  • 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.

    PMID: 28419032BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Arthroplasty, Replacement, HipPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis ImplantationTherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 10, 2019

First Posted

December 13, 2019

Study Start

July 31, 2018

Primary Completion

October 7, 2019

Study Completion

October 7, 2019

Last Updated

December 13, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)