免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Telemedicine in Total Hip Arthroplasty and Total Knee Arthroplasty

Telemedicine in Total Hip Arthroplasty and Total Knee Arthroplasty

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.

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 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
Actual Primary Completion Date : May 22, 2020
Actual Study Completion Date : May 22, 2020
Arms and Interventions
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.
Outcome Measures
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.


Eligibility Criteria
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.
Contacts and Locations

Locations
Layout table for location information
United States, South Carolina
Steadman Hawkins Clinic of the Carolinas
Greenville, South Carolina, United States, 29615
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
Tracking Information
First Submitted Date  ICMJE May 22, 2019
First Posted Date  ICMJE May 23, 2019
Last Update Posted Date August 4, 2020
Actual Study Start Date  ICMJE May 10, 2019
Actual Primary Completion Date May 22, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2019) 		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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2019) 		Patient reported satisfaction [ Time Frame: 9 weeks ]
Client Satisfaction Questionnaire will be used to assess patient satisfaction of their 3 week encounter both at 3 and 9 weeks post-operatively.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019) 		Patient reported overall quality of life measures [ Time Frame: 9 weeks ]
Quality of Life assessed via EQ-5D Questionnaire
Current Other Pre-specified Outcome Measures
 (submitted: May 28, 2019)
  • 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.
  • Adverse Events [ Time Frame: 9 weeks ]
    Adverse events will be tracked for both groups and compared.
  • 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).
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: May 22, 2019)
  • Patient reported pain level [ Time Frame: 9 weeks ]
    Pain assessed via Visual Analog Score (VAS)
  • Adverse Events [ Time Frame: 9 weeks ]
    Adverse events will be tracked for both groups and compared.
  • Time spent during 3-week post-operative encounter [ Time Frame: 3 weeks ]
    Post op telephone follow up duration compared to clinic follow up duration (measured in minutes).
 
Descriptive Information
Brief Title  ICMJE Telemedicine in Total Hip Arthroplasty and Total Knee Arthroplasty
Official Title  ICMJE Randomized Controlled Trial Assessing Post-operative Telemedicine Versus In-Person Clinic Visits in Hip and Knee Arthroplasty
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Knee Osteoarthritis
  • Hip Osteoarthritis
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Telemedicine
  • 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.
    Intervention: Procedure: In-Person Clinic Visit
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 3, 2020) 		98
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2019) 		176
Actual Study Completion Date  ICMJE May 22, 2020
Actual Primary Completion Date May 22, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03961711
Other Study ID Numbers  ICMJE Pro00087297
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party The Hawkins Foundation
Study Sponsor  ICMJE The Hawkins Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brian Burnikel, MD Steadman Hawkins Clinic of the Carolinas - Greenville Health System
PRS Account The Hawkins Foundation
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯