OsteoarthritisNCT01370252
Arthroscopic Ankle Arthrodesis: Measuring Post-operative Pain to Assess the Potential for Outpatient Surgery.
An observational study of Osteoarthritis, run by Hammond, Allan, M.D. at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients selected from the surgeons waitlist.
Who may be able to join
- Ankle osteoarthritis with adequate bone stock
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9
Allan Hammond, MD FRCSC, 204 451-5702, erahammond@gmail.com
Allan Hammond, MD, FRCSC.
About this study
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.
- Conditions
- Osteoarthritis
- Keywords
- ankle arthrodesis, pain, arthroscopic technique, ankle osteoarthritis
- Medical subject headings
- Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| scope technique | Not described | |
| open technique | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: recorded for one week post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hammond, Allan, M.D.
- Investigators
- Allan Hammond, MD, FRCSC, Principal investigator, University of Manitoba, Faculty of Medicine, Department of Orthopedics, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370252
- Sponsor's protocol ID
- H2011:070
- Status last verified
- Jun 2011
- First submitted
- 8 Jun 2011
- Last updated
- 9 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Ankle Arthrodesis: Measuring Post-operative Pain to Assess the Potential for Outpatient Surgery.
- ClinicalTrials.gov ID
- NCT01370252
- Acronym / sponsor ID
- H2011:070
- Conditions
- Osteoarthritis
- Keywords
- ankle arthrodesis, pain, arthroscopic technique, ankle osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hammond, Allan, M.D.
- Study start
- Jun 2011
- First posted
- 9 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| scope technique | – | – |
| open technique | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients selected from the surgeons waitlist.
Key inclusion criteria (1 listed)
- Ankle osteoarthritis with adequate bone stock
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan Hammond, MD, FRCSC principal investigator
University of Manitoba, Faculty of Medicine, Department of Orthopedics, Assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Hammond, Allan, M.D. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Pain Scale (NRPS) (time frame: recorded for one week post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2011.