CClinicalTrials.gg
Status unknownNCT03607461Updated Jul 31, 2018

Using a Smartphone App to Aid in Functional Mobility Return Following Total Knee Arthroplasty

An interventional study of Smartphone App and Control Group in Total Knee Arthroplasty, sponsored by Lagniappe Physical Therapy. Status unknown at 1 site in United States. Open to participants aged 45 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-31.

Sponsored by Lagniappe Physical Therapy · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
45 Years to 64 Years
Sex
All
01

Study summary

Traditional home health care for individuals recovering from unilateral TKA is expensive and provides a higher level of service than most individuals, aged 45 to 64, require. Use of smartphone technology has the potential to drive down costs while maintaining outcomes for this patient population. The proposed randomized controlled trial would determine the efficacy and proper dose-response of a smartphone app to reduce costs and maintain outcomes for the desired patient population compared to traditional home care.

Read the detailed description

As of 2013, it was estimated that 4.0 million individuals in the U.S. were living with a TKA, representing 4.2% of the population fifty years of age or older (8). As of 2010, there were 81,489,445 people aged 45 to 64 in the U.S. (4), with a rate of 39.5 total knee arthroplasties per year per 10,000 individuals in that age group (3). Therefore, approximately 322,000 TKAs were performed in 2010 for those aged 45 to 64. A 2010 study from The Centers for Disease Control and Prevention found the average cost of home health care following TKA to be $3,709 per episode of care per patient (5). This results in nearly $1.2 billion dollars in U.S. healthcare spending in 2010 for home care following TKA for those aged 45 to 64. The reason for the high cost of home health care may be the state regulations governing home health care agencies. The Louisiana Department of Health and Hospitals states that 'skilled home health care,' found under the definition of 'home health agency' in the official Louisiana Home Health State Regulations, is to include skilled nursing and at least one of the following services: physical therapy, occupational therapy, speech therapy, medical social services, or home health aide services (9). These regulations place pressure, whether conscious or subconscious, on the home health agency to over utilize skilled nursing services for those patients aged 45 to 64 recovering from TKA. Skilled nursing home health care services for this particular patient population usually involves managing the patient's medications and providing wound care services. A cohort study by Bleijenberg et al published in the Journal of the American Geriatric Society in 2017 found that only 10.3% of adults aged 65 to 69, which is above the age cutoff for this prospective study, had difficulty with managing their medications (10). Also, in the author's clinical experience, it is rare for an orthopedic surgeon to allow any other clinician to manage post-operative dressing changes except those clinicians under the surgeon's direct supervision; though further research in this area would be helpful. Furthermore, utilization of TKA, and the home care cost associated with recovery from TKA, is on the rise. As of 2009, the number of primary TKAs performed annually in the U.S. among all age groups exceeded 620,000 procedures, which is more than doubled when compared to the previous decade (7). Smartphones and other technologies may provide a solution to the rising costs of home health care following TKA for those aged 45 to 64. Over the past decade, the smartphone has become an integral part of most people's lives. The latest Pew Research Data from February 2018 shows that 73% of individuals aged 50 to 64 own a smartphone (8). Smartphones would allow the patient to have direct multimedia access to a prescriptive exercise program designed by a licensed Physical Therapist without an in-person home visit, as well as to have communication directly with their Physical Therapist through secure in-app messaging or e-mail. The patient would benefit by having reduced intrusion in their home environment, convenient access to their Physical Therapist and their Physical Therapist's plan of care, and financial savings due to the elimination of home health care services following TKA. The Physical Therapist would benefit from the ability to quickly interact with the patient to mitigate any adverse events and to efficiently assist a greater number of patients compared to traditional home-based physical therapy. Third-party payors would benefit from drastically reduced home care costs for those recovering from TKA.

02

Conditions studied

  • Total Knee Arthroplasty
03

In context

Lead sponsor

This is the only study on the registry with Lagniappe Physical Therapy as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • participants aged 45 to 64
  • unilateral TKA
  • subject discharged directly to home from the hospital

Exclusion criteria

Exclusion Criteria:

  • subject does not engage with the app within 24 hours of discharge from the hospital
  • subject neglects to engage with the app over any 24-hour period during the study
  • subject is readmitted to the hospital at any point during the home bound portion of their recovery
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Smartphone App Users

    Smartphone App Users will receive important information and prescriptive exercise via a smartphone app upon returning home from the hospital following total knee arthroplasty

    Device: Smartphone App

  • Active comparator
    Home Health Users

    Home Health Users will have already undergone traditional home health physical therapy and/or skilled nursing for the purpose of comparing outcomes

    Combination Product: Control Group

Interventions

  • DeviceSmartphone App

    Smartphone App Users will engage with the app at least daily and follow along with the prescriptive exercises as instructed.

  • Combination productControl Group

    Home Health users will have received traditional home health physical therapy and skilled nursing services.

06

What researchers measure

Primary outcomes

  1. Total Knee Range of Motion (ROM) change

    Initial knee ROM will be taken within 48 hours of discharge home from hospital. Final knee ROM will be taken upon participant no longer being homebound and expressing readiness to begin outpatient physical therapy

    Time frame: Baseline and through study completion, usually 2 to 4 weeks

  2. Western Ontario and McMaster Universities Osteoarthritis Index (shortened version)

    Questionnaire to be completed by participant at time of initial data collection described above. Final questionnaire also completed as described above

    Time frame: Baseline and through study completion, usually 2 to 4 weeks

Secondary outcomes

  1. Self-Reported App Engagement

    Participant will self-report frequency of app engagement

    Time frame: Data collected at final assessment, usually 2 to 4 weeks

07

Study locations

1 of 1 sites recruiting
  • Office
    Shreveport, Louisiana 71106, United States
    • Eric M Rippetoe, DPT · Contact · Errippetoe@aol.com · 318-560-5726
    • Eric M Rippetoe, DPT · Principal investigator
    Recruiting
08

References and documents

Publications

  • Whitehouse SL, Lingard EA, Katz JN, Learmonth ID. Development and testing of a reduced WOMAC function scale. J Bone Joint Surg Br. 2003 Jul;85(5):706-11. PubMed 12892194 ↗
  • Abbott JH, Hobbs C, Gwynne-Jones D; MOA Trial Team. The ShortMAC: Minimum Important Change of a Reduced Version of the Western Ontario and McMaster Universities Osteoarthritis Index. J Orthop Sports Phys Ther. 2018 Feb;48(2):81-86. doi: 10.2519/jospt.2018.7676. Epub 2017 Oct 21. PubMed 29056072 ↗
  • Weinstein AM, Rome BN, Reichmann WM, Collins JE, Burbine SA, Thornhill TS, Wright J, Katz JN, Losina E. Estimating the burden of total knee replacement in the United States. J Bone Joint Surg Am. 2013 Mar 6;95(5):385-92. doi: 10.2106/JBJS.L.00206. PubMed 23344005 ↗
  • Losina E, Thornhill TS, Rome BN, Wright J, Katz JN. The dramatic increase in total knee replacement utilization rates in the United States cannot be fully explained by growth in population size and the obesity epidemic. J Bone Joint Surg Am. 2012 Feb 1;94(3):201-7. doi: 10.2106/JBJS.J.01958. PubMed 22298051 ↗
  • Bleijenberg N, Smith AK, Lee SJ, Cenzer IS, Boscardin JW, Covinsky KE. Difficulty Managing Medications and Finances in Older Adults: A 10-year Cohort Study. J Am Geriatr Soc. 2017 Jul;65(7):1455-1461. doi: 10.1111/jgs.14819. Epub 2017 Apr 5. PubMed 28378345 ↗

Study documents

  • Study protocol · Jun 20, 2018
  • Informed consent form · Jun 24, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — There are no plans to make IPD available to other researchers

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03607461
Lead sponsor
Lagniappe Physical Therapy
Responsible party
Sponsor
First posted
Jul 31, 2018
Start date
Jul 2018 (estimated)
Primary completion
Aug 2018 (estimated)
Completion
Sep 2018 (estimated)
Last update
Jul 31, 2018

Study contacts

Eric M Rippetoe, DPT
Contact
eric@lagniappept.com
318-560-5726
Eric M Rippetoe, DPT
principal investigator · Owner of Lagniappe Physical Therapy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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