Clinical trial NCT03961711: Telemedicine in Total Hip Arthroplasty and Total Knee Arthroplasty
Official title: Randomized Controlled Trial Assessing Post-operative Telemedicine Versus In-Person Clinic Visits in Hip and Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Hip Osteoarthritis
Lead sponsor: The Hawkins Foundation
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate patient perspective on telemedicine used in 3 week post operative visits for knee and hip arthroplasty. It is hypothesized that patient satisfaction with telemedicine follow-up is equal to patient satisfaction with in-office followup. Patient satisfaction will be assessed at the 3-week and 9-week post-operative timepoints.

Detailed description: In 2014 there were 370,770 total hip replacements and 680,150 total knee replacements performed in the United States. As the elderly proportion of the population continues to grow, it is estimated that the number of total hip arthroplasty will grow by 71 percent and total knee arthroplasty will grow by 85 percent by the year 2030 (Sloan, M The Journal of Bone and Joint Surgery 2018). As these numbers continue to rise, health care delivery must evolve into a more efficient, cost effective system without compromising the quality of the care delivered.

Telemedicine involves using electronic communications and software to provide clinical services to patients in place of an in-person visit. Benefits of telemedicine include avoiding unnecessary trips to hospitals, saving time, and reducing the number of working days missed (Asiri, A Acta Inform Med 2018). Used in general surgery followup care, anonymous survey responses demonstrated a high degree of satisfaction with 85% expressing a desire to utilize telemedicine for followup care in the future (Nikolian, V Annals of Surgery 2018). Postoperative telemedicine has been studied in many specialties, but literature exploring its use in orthopedics has been scant.

Eligibility criteria: Inclusion Criteria:

There will be two arms of this study, knee and hip patients.

* Knee: All adult patients over the age of 18 scheduled for a primary total knee arthroplasty will be eligible for the inclusion in the study.
* Hips: All adult patients over the age of 18 scheduled for a primary total hip arthroplasty will be eligible for the inclusion in the study.

Exclusion Criteria:

* lack of access to a telephone
* history of wound complications
* venous thromboembolism (deep vein thrombosis and/or pulmonary embolism),
* significant cardiac history (myocardial infarction, angina, stroke, lower limb ischemia)
* Subject with any condition (including cognitive impairment) that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Primary outcomes:
measure: Patient reported satisfaction
timeFrame: 9 weeks
Secondary outcomes:
Other outcomes:
measure: Patient reported pain level
timeFrame: 9 weeks
measure: Adverse Events
timeFrame: 9 weeks
measure: Time spent during 3-week post-operative encounter
timeFrame: 3 weeks
measure: Patient reported overall quality of life measures
timeFrame: 9 weeks
Locations:
city: Greenville
country: United States
facility: Steadman Hawkins Clinic of the Carolinas
state: South Carolina
Study officials:
affiliation: Steadman Hawkins Clinic of the Carolinas - Greenville Health System
name: Brian Burnikel, MD
role: PRINCIPAL_INVESTIGATOR
References: