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Physical Therapy Following Total Hip Arthroplasty

Primary Purpose

Hip Osteoarthritis, Surgery

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

total hip arthroplasty

About this trial

This is an interventional treatment trial for Hip Osteoarthritis focused on measuring total hip arthroplasty, physical therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Orthopedic One

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Clinic-based Physical Therapy

Home-based Physical Therapy

Arm Description

Outcomes

Primary Outcome Measures

Change in Hip Disability and Osteoarthritis Outcome Scores

Change in SF-12v2 Scores

Secondary Outcome Measures

Full Information

NCT ID

NCT04199390

First Posted

December 10, 2019

Last Updated

December 12, 2019

Sponsor

Orthopedic One

Collaborators

Medacta USA

1. Study Identification

Unique Protocol Identification Number

NCT04199390

Brief Title

Physical Therapy Following Total Hip Arthroplasty

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

July 31, 2018 (Actual)

Primary Completion Date

October 7, 2019 (Actual)

Study Completion Date

October 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Orthopedic One

Collaborators

Medacta USA

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hip Osteoarthritis, Surgery

Keywords

total hip arthroplasty, physical therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

130 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Clinic-based Physical Therapy

Arm Type

Active Comparator

Arm Title

Home-based Physical Therapy

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

total hip arthroplasty

Other Intervention Name(s)

physical therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Hip Disability and Osteoarthritis Outcome Scores

Time Frame

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

Title

Change in SF-12v2 Scores

Time Frame

preoperative and postoperative 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Orthopedic One

City

Dublin

State/Province

Ohio

ZIP/Postal Code

43016

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25714040

Citation

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.

Results Reference

background

PubMed Identifier

25765130

Citation

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.

Results Reference

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PubMed Identifier

12771834

Citation

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.

Results Reference

background

PubMed Identifier

18586222

Citation

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.

Results Reference

background

PubMed Identifier

19238130

Citation

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.

Results Reference

background

PubMed Identifier

15577494

Citation

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.

Results Reference

background

PubMed Identifier

19277807

Citation

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.

Results Reference

background

PubMed Identifier

28419032

Citation

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.

Results Reference

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Physical Therapy Following Total Hip Arthroplasty

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