Physical Therapy Following Total Hip Arthroplasty

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04199390
• Other study ID #: 20181607
• Status: Completed
• Phase: N/A
• Start date: July 31, 2018
• Est. completion date: October 7, 2019

Study information

• Verified date: December 2019
• Source: Orthopedic One
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: October 7, 2019
• Est. primary completion date: October 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis, Hip
• Surgery

Intervention

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

Locations

Country	Name	City	State
United States	Orthopedic One	Dublin	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Orthopedic One	Medacta USA

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hip Disability and Osteoarthritis Outcome Scores		preoperative, postoperative 6 weeks, postoperative 12 weeks, and postoperative 24 weeks
Primary	Change in SF-12v2 Scores		preoperative and postoperative 24 weeks