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Completed

NCT Number: NCT03961711

Telemedicine in Total Hip Arthroplasty and Total Knee Arthroplasty

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Hip Osteoarthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Steadman Hawkins Clinic of the Carolinas

Greenville, South Carolina, 29615, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telemedicine

Procedure

Patients 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

Procedure

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

The Hawkins Foundation

Other

Registry information

Official study title

Randomized Controlled Trial Assessing Post-operative Telemedicine Versus In-Person Clinic Visits in Hip and Knee Arthroplasty

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 23, 2019
Registry last updated
Aug 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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