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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Hammond, Allan, M.D..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hammond, Allan, M.D.
ClinicalTrials.gov Identifier:
NCT01370252
First received: June 8, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

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.


Condition
Osteoarthritis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Arthroscopic Ankle Arthrodesis: Measuring Post-operative Pain to Assess the Potential for Outpatient Surgery.

Resource links provided by NLM:


Further study details as provided by Hammond, Allan, M.D.:

Primary Outcome Measures:
  • Numeric Rating Pain Scale (NRPS) [ Time Frame: recorded for one week post-operatively ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: June 2011
Groups/Cohorts
scope technique
open technique

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients selected from the surgeons waitlist.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01370252

Locations
Canada, Manitoba
Health Sciences Centre Recruiting
Winnipeg, Manitoba, Canada, R3A 1R9
Contact: Allan Hammond, MD FRCSC    204 451-5702    erahammond@gmail.com   
Principal Investigator: Allan Hammond, MD, FRCSC.         
Sponsors and Collaborators
Hammond, Allan, M.D.
Investigators
Principal Investigator: Allan Hammond, MD, FRCSC University of Manitoba, Faculty of Medicine, Department of Orthopedics, Assistant professor
  More Information

No publications provided

Responsible Party: Dr. Allan Hammond, University of Manitoba, Assistant Professor, Faculty of Medicine
ClinicalTrials.gov Identifier: NCT01370252     History of Changes
Other Study ID Numbers: H2011:070
Study First Received: June 8, 2011
Last Updated: June 8, 2011
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Hammond, Allan, M.D.:
ankle arthrodesis
pain
arthroscopic technique
ankle osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Pain, Postoperative
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014