Osteoarthritis in the Knee JointNCT01079572
Cost-Effectiveness of Web-Based Follow Ups
A study testing in-person and web-based in people with Osteoarthritis in the Knee Joint and Osteoarthritis in the Hip Joint, run by University of Western Ontario, Canada at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis in the Knee Joint, Osteoarthritis in the Hip Joint
- What is being tested?
- in-person and web-based
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2010to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients who have had a primary total hip or total knee arthroplasty
Who cannot join
- patients with osteolysis, or previous complications from their joint replacement
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Centre - University Hospital
London, Ontario, N6G 1H1
About this study
Official title: Cost-Effectiveness of Web-Based Follow Up Following Total Joint Arthroplasty
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.
Read more
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.
- Being tested
- in-person, web-based
- Keywords
- osteoarthritis, arthroplasty, web-based, electronic follow-up
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in-personOther
Follow-up appointments will be completed in-person as per usual
web-basedOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: web-based |
| in-person | Active comparator | Patients will attend their follow-up appointments in-person as per usual Receives: Other: in-person |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-effectiveness
Measured: one year
Secondary outcomes (4)
Harris Hip Score
Measured: one year
Western Ontario and McMaster Osteoarthritis Index (WOMAC)
Measured: one year
SF-12
Measured: one year
Adverse events
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis in the Knee JointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Western Ontario, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Principal investigator, Dianne Bryant, University of Western Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079572
- Sponsor's protocol ID
- PSI-2010-01
- Status last verified
- Feb 2013
- First submitted
- 1 Mar 2010
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25410510Marsh 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.
PubMed 24881023Marsh 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.
PubMed 24562873
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-Effectiveness of Web-Based Follow Up Following Total Joint Arthroplasty
- ClinicalTrials.gov ID
- NCT01079572
- Acronym / sponsor ID
- PSI-2010-01
- Keywords
- osteoarthritis, arthroplasty, web-based, electronic follow-up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- University of Western Ontario, CanadaUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Feb 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 3 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| web-based | Experimental | Other: web-basedThe 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. |
| in-person | Active comparator | Other: in-personPatients will attend their follow-up appointments in-person as per usual |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients who have had a primary total hip or total knee arthroplasty
Key exclusion criteria (1 listed)
- patients with osteolysis, or previous complications from their joint replacement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| in-personFollow-up appointments will be completed in-person as per usual | Other | in-person |
| web-basedPatients 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. | Other | web-based |
Primary outcome
Cost-effectiveness
Time frame: one year
4 secondary outcomes
Harris Hip Score
Time frame: one year
Western Ontario and McMaster Osteoarthritis Index (WOMAC)
Time frame: one year
SF-12
Time frame: one year
Adverse events
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
- Derived from this study: PubMed 25410510Marsh 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.
- Derived from this study: PubMed 24881023Marsh 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.
- Derived from this study: PubMed 24562873Marsh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing in-person and web-based in people with Osteoarthritis in the Knee Joint and Osteoarthritis in the Hip Joint, run by University of Western Ontario, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-effectiveness (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01079572, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2013.