Telemedicine in Total Hip Arthroplasty and Total Knee Arthroplasty
Primary Purpose
Knee Osteoarthritis, Hip Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telemedicine
In-Person Clinic Visit
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
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.
Sites / Locations
- Steadman Hawkins Clinic of the Carolinas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Telemedicine encounter
In-person Clinic Visit
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03961711
Brief Title
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
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 10, 2019 (Actual)
Primary Completion Date
May 22, 2020 (Actual)
Study Completion Date
May 22, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hawkins Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Hip Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telemedicine encounter
Arm Type
Experimental
Arm Description
Patients will undergo a Telemedicine encounter with the physician at the 3-week post-operative timepoint following a total hip or total knee arthroplasty.
Arm Title
In-person Clinic Visit
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Telemedicine
Intervention Description
Patients will undergo a Telemedicine encounter with the physician at the 3-week post-operative timepoint following a total hip or total knee arthroplasty.
Intervention Type
Procedure
Intervention Name(s)
In-Person Clinic Visit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient reported satisfaction
Description
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.
Time Frame
9 weeks
Other Pre-specified Outcome Measures:
Title
Patient reported pain level
Description
Pain assessed via Visual Analog Score (VAS), 0-10, with 0 being no pain and 10 being extreme pain.
Time Frame
9 weeks
Title
Adverse Events
Description
Adverse events will be tracked for both groups and compared.
Time Frame
9 weeks
Title
Time spent during 3-week post-operative encounter
Description
Post-operative telemedicine follow up duration compared to clinic follow up duration (measured in minutes).
Time Frame
3 weeks
Title
Patient reported overall quality of life measures
Description
Quality of Life assessed via EuroQol-5 Dimensions (EQ-5D) Questionnaire. Levels of perceived problems are coded with 1 being the best outcome and 3 being the worst. The overall health scale portion of the EQ-5D (EQ VAS) is scored on a scale of 0-100, with 100 being the best and 0 being the worst.
Time Frame
9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Burnikel, MD
Organizational Affiliation
Steadman Hawkins Clinic of the Carolinas - Greenville Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steadman Hawkins Clinic of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Telemedicine in Total Hip Arthroplasty and Total Knee Arthroplasty
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