Telemedicine in Total Hip Arthroplasty and Total Knee Arthroplasty
Randomized Controlled Trial Assessing Post-operative Telemedicine Versus In-Person Clinic Visits in Hip and Knee Arthroplasty
1 other identifier
interventional
98
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable knee-osteoarthritis
Started May 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2019
CompletedFirst Submitted
Initial submission to the registry
May 22, 2019
CompletedFirst Posted
Study publicly available on registry
May 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2020
CompletedAugust 4, 2020
August 1, 2020
1 year
May 22, 2019
August 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Patient reported satisfaction
Client Satisfaction Questionnaire (CSQ-8) will be used to assess patient satisfaction of the 3 week encounter both at 3 and 9 weeks post-operatively. The scale of the survey ranges from 8-32, with 32 being the best score and 8 being the worst. The higher a patient scores, the more satisfied the patient is with the care provided.
9 weeks
Other Outcomes (4)
Patient reported pain level
9 weeks
Adverse Events
9 weeks
Time spent during 3-week post-operative encounter
3 weeks
- +1 more other outcomes
Study Arms (2)
Telemedicine encounter
EXPERIMENTALPatients will undergo a Telemedicine encounter with the physician at the 3-week post-operative timepoint following a total hip or total knee arthroplasty.
In-person Clinic Visit
ACTIVE COMPARATORPatients will undergo an in-person clinic encounter with the physician at the 3-week post-operative timepoint following a total hip or total knee arthroplasty.
Interventions
Patients will undergo a Telemedicine encounter with the physician at the 3-week post-operative timepoint following a total hip or total knee arthroplasty.
Patients will undergo an in-person clinic encounter with the physician at the 3-week post-operative timepoint following a total hip or total knee arthroplasty.
Eligibility Criteria
You may qualify if:
- There will be two arms of this study, knee and hip patients.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Steadman Hawkins Clinic of the Carolinas
Greenville, South Carolina, 29615, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Burnikel, MD
Steadman Hawkins Clinic of the Carolinas - Greenville Health System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2019
First Posted
May 23, 2019
Study Start
May 10, 2019
Primary Completion
May 22, 2020
Study Completion
May 22, 2020
Last Updated
August 4, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share