NCT01370252

Brief 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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2011

Completed
Last Updated

June 9, 2011

Status Verified

June 1, 2011

First QC Date

June 8, 2011

Last Update Submit

June 8, 2011

Conditions

Keywords

ankle arthrodesispainarthroscopic techniqueankle osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

scope technique

open technique

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients selected from the surgeons waitlist.

You may qualify if:

  • Ankle osteoarthritis with adequate bone stock

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

RECRUITING

MeSH Terms

Conditions

OsteoarthritisPain

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Allan Hammond, MD, FRCSC

    University of Manitoba, Faculty of Medicine, Department of Orthopedics, Assistant professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDIV

Study Record Dates

First Submitted

June 8, 2011

First Posted

June 9, 2011

Study Start

June 1, 2011

Last Updated

June 9, 2011

Record last verified: 2011-06

Locations