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NCT01370252 Clinical Trial

Arthroscopic Ankle Arthrodesis: Measuring Post-operative Pain to Assess the Potential for Outpatient Surgery.

Osteoarthritis Clinical Trial

Official title:
Arthroscopic Ankle Arthrodesis: Measuring Post-operative Pain to Assess the Potential for Outpatient Surgery.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01370252
Other study ID # H2011:070
Secondary ID
Status Recruiting
Phase N/A
First received June 8, 2011
Last updated June 8, 2011
Start date June 2011

Study information
Verified date June 2011
Source Hammond, Allan, M.D.
Contact n/a
Is FDA regulated No
Health authority Canada: Canadian Institutes of Health Research
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Canada Health Sciences Centre Winnipeg Manitoba

Sponsors (1)
Lead Sponsor Collaborator
Hammond, Allan, M.D.

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Numeric Rating Pain Scale (NRPS) 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 No
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