Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Telemedicine in Total Hip Arthroplasty and Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03961711
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
The Hawkins Foundation

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Hip Osteoarthritis Procedure: Telemedicine Procedure: In-Person Clinic Visit Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Assessing Post-operative Telemedicine Versus In-Person Clinic Visits in Hip and Knee Arthroplasty
Actual Study Start Date : May 10, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: Telemedicine encounter
Patients will undergo a Telemedicine encounter with the physician at the 3-week post-operative timepoint following a total hip or total knee arthroplasty.
Procedure: Telemedicine
Patients will undergo a Telemedicine encounter with the physician at the 3-week post-operative timepoint following a total hip or total knee arthroplasty.

Active Comparator: In-person Clinic Visit
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.
Procedure: In-Person Clinic Visit
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 Measures :
  1. Patient reported satisfaction [ Time Frame: 9 weeks ]

    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.



Other Outcome Measures:
  1. Patient reported pain level [ Time Frame: 9 weeks ]
    Pain assessed via Visual Analog Score (VAS), 0-10, with 0 being no pain and 10 being extreme pain.

  2. Adverse Events [ Time Frame: 9 weeks ]
    Adverse events will be tracked for both groups and compared.

  3. Time spent during 3-week post-operative encounter [ Time Frame: 3 weeks ]
    Post-operative telemedicine follow up duration compared to clinic follow up duration (measured in minutes).

  4. Patient reported overall quality of life measures [ Time Frame: 9 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961711


Contacts
Layout table for location contacts
Contact: Kyle J Adams, BS 864-454-7458 Kyle.Adams@hawkinsfoundation.com

Locations
Layout table for location information
United States, South Carolina
Steadman Hawkins Clinic of the Carolinas Recruiting
Greenville, South Carolina, United States, 29615
Contact: Kyle Adams, BS    864-454-7458    kyle.adams@hawkinsfoundation.com   
Sponsors and Collaborators
The Hawkins Foundation
Investigators
Layout table for investigator information
Principal Investigator: Brian Burnikel, MD Steadman Hawkins Clinic of the Carolinas - Greenville Health System

Layout table for additonal information
Responsible Party: The Hawkins Foundation
ClinicalTrials.gov Identifier: NCT03961711     History of Changes
Other Study ID Numbers: Pro00087297
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases