Clinical trial NCT04199390: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Surgery
Keywords: total hip arthroplasty
physical therapy
Lead sponsor: Orthopedic One
Sponsor class: OTHER
Collaborators: name: Medacta USA
First posted: 2019-12-13
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Hip Disability and Osteoarthritis Outcome Scores
timeFrame: preoperative, postoperative 6 weeks, postoperative 12 weeks, and postoperative 24 weeks
measure: Change in SF-12v2 Scores
timeFrame: preoperative and postoperative 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: United States
facility: Orthopedic One
state: Ohio
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.
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.