- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01370252
Arthroscopic Ankle Arthrodesis: Measuring Post-operative Pain to Assess the Potential for Outpatient Surgery.
June 8, 2011 updated by: Hammond, Allan, M.D.
Post-operative pain will be measured using a pain diary for one week post-surgery.
The purpose is to test the assumption that the arthroscopic technique leads to less post-operative pain and results in shorter hospital stays when compared to the open technique.
It is believed that the arthroscopic technique will result in minimal pain when compared to the open technique, allowing this procedure to be performed as day surgery.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3A 1R9
- Recruiting
- Health Sciences Centre
-
Contact:
- Allan Hammond, MD FRCSC
- Phone Number: 204 451-5702
- Email: erahammond@gmail.com
-
Principal Investigator:
- Allan Hammond, MD, FRCSC.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients selected from the surgeons waitlist.
Description
Inclusion Criteria:
- Ankle osteoarthritis with adequate bone stock
Exclusion Criteria:
- Mental or physical inability to consent or answer pain questions, pre-operative or peri-operative morbidity impairing mobility, pre-operative opioid therapy, non-steroidal anti-inflammatory drugs or steroids within 24 hours before skin incision, kidney or liver dysfunction, morbid obesity, smoking, significant bony deformity, significant loss of bone stock or diabetes with sensory changes will be cause for exclusion.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
scope technique
|
open technique
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Rating Pain Scale (NRPS)
Time Frame: recorded for one week post-operatively
|
A scale from 0-10 is used for patients to record the amount of pain they are experiencing at a given time.
Multiple questions are asked on a daily basis in a pain diary to report pain in the morning, at night, with movement, before and after pain medication.
|
recorded for one week post-operatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Allan Hammond, MD, FRCSC, University of Manitoba, Faculty of Medicine, Department of Orthopedics, Assistant professor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Study Registration Dates
First Submitted
June 8, 2011
First Submitted That Met QC Criteria
June 8, 2011
First Posted (Estimate)
June 9, 2011
Study Record Updates
Last Update Posted (Estimate)
June 9, 2011
Last Update Submitted That Met QC Criteria
June 8, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H2011:070
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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