NCT01079572

Brief Summary

Complications following total joint arthroplasty are rare, and the majority of follow-up visits are routine. The technology now exists to conduct annual follow-up assessments without having to physically see the patient. This study will investigate the cost-effectiveness of web-based follow-up assessments compared to standard in-clinic follow-ups. We will also assess patient satisfaction, preference, and the validity of the web-based follow up assessments. Patients coming up to their 1 year follow-up or greater will be randomized to either the web-based group or the usual care group. Web-based patients will complete all questionnaires using an online database system, and have their x-ray taken at their local radiology facility. The surgeon will review radiographs online. If there are any concerns with the x-ray or responses to questionnaires, arrangements will be made for the patient to be seen at the clinic. Patients in the Usual Care group will come into the clinic for their follow-up assessment and have their x-ray taken at University Hospital as usual. Online assessment could significantly decrease wait times in orthopaedic clinics, as well as increase availability for OR time and new consultations. This approach could also potentially reduce patient burden by decreasing travel distances, financial burden and time requirements.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

February 7, 2013

Status Verified

February 1, 2013

Enrollment Period

1.1 years

First QC Date

March 1, 2010

Last Update Submit

February 6, 2013

Conditions

Keywords

osteoarthritisarthroplastyweb-basedelectronic follow-up

Outcome Measures

Primary Outcomes (1)

  • Cost-effectiveness

    one year

Secondary Outcomes (4)

  • Harris Hip Score

    one year

  • Western Ontario and McMaster Osteoarthritis Index (WOMAC)

    one year

  • SF-12

    one year

  • Adverse events

    one year

Study Arms (2)

web-based

EXPERIMENTAL

The patient will undergo xrays at the closest PACs enabled imaging centre and will login and answer questions online. The surgeon will review the images and patient responses and determine whether the patient needs to be seen more urgently or a per routine.

Other: web-based

in-person

ACTIVE COMPARATOR

Patients will attend their follow-up appointments in-person as per usual

Other: in-person

Interventions

Follow-up appointments will be completed in-person as per usual

in-person

Patients who are at least 2 years following knee or hip replacement will complete a questionnaire online and routine x-rays at a PACS enabled imaging center. The patient's surgeon will receive an email from the database summarizing the patient's responses to key questions and will review the x-rays. The surgeon will determine whether the patient needs to be seen in-person.

web-based

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients who have had a primary total hip or total knee arthroplasty

You may not qualify if:

  • patients with osteolysis, or previous complications from their joint replacement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre - University Hospital

London, Ontario, N6G 1H1, Canada

Location

Related Publications (3)

  • Marsh J, Hoch JS, Bryant D, MacDonald SJ, Naudie D, McCalden R, Howard J, Bourne R, McAuley J. Economic evaluation of web-based compared with in-person follow-up after total joint arthroplasty. J Bone Joint Surg Am. 2014 Nov 19;96(22):1910-6. doi: 10.2106/JBJS.M.01558.

  • Marsh JD, Bryant DM, MacDonald SJ, Naudie DD, McCalden RW, Howard JL, Bourne RB, McAuley JP. Feasibility, effectiveness and costs associated with a web-based follow-up assessment following total joint arthroplasty. J Arthroplasty. 2014 Sep;29(9):1723-8. doi: 10.1016/j.arth.2014.04.003. Epub 2014 Apr 13.

  • Marsh J, Bryant D, MacDonald SJ, Naudie D, Remtulla A, McCalden R, Howard J, Bourne R, McAuley J. Are patients satisfied with a web-based followup after total joint arthroplasty? Clin Orthop Relat Res. 2014 Jun;472(6):1972-81. doi: 10.1007/s11999-014-3514-0. Epub 2014 Feb 22.

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 1, 2010

First Posted

March 3, 2010

Study Start

February 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

February 7, 2013

Record last verified: 2013-02

Locations