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

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Recruiting
        • Health Sciences Centre
        • Contact:
        • 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

Hammond, Allan, M.D.

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

Keywords

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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