Pain ManagementNCT00474773
Evaluation of Post Hospital Administration of Celecoxib Following Minimally Invasive Knee Replacement Surgery
An observational study of Pain Management and Function, run by St. Louis Joint Replacement Institute at 1 site in United States.
Trial summary
This study will evaluate the benefits of continuing celecoxib through six weeks of total knee arthroplasty recovery. This is a randomized, double blind study with a group of approximately 130 primary total knee patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain Management, Function, Minimally Invasive Total Knee Arthroplasty
- What is being tested?
- Celecoxib
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Dec 2009
- 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
- Child, Adult, Older adult
Study population: total knee canidates
Who may be able to join
- having undergone a minimally invasive total knee by select surgeon
- voluntarily enrolled
- independent community ambulators
- only patients being discharged directly home
Who cannot join
- celecoxib allergy or intolerence
- Renal insufficiency (defined as serum creatine level >1.5 mg/dL or BUN level >22mg/dL
- History of bleeding gastic or duodenal ulceration
- New York Heart Association Class III or IV Congestive Heart Failure
- Previous myocardial infarction or cerebralvascular event
- Severe inflammatory bowel disease
Show all 9Show fewer
- Known coagulation abnormality or hepatic disease
- Chronic coumadin administration
- Refusal by primary or cardiac physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Post Hospital Administration of Celecoxib Following Minimally Invasive Knee Replacement Surgery: A Randomized Controlled Study
This study will evaluate the benefits of continuing celecoxib through six weeks of total knee arthroplasty recovery. This is a randomized, double blind study with a group of approximately 130 primary total knee patients. All patients will receive celecoxib throughout their hospitalization as per current minimally invasive total knee arthroplasty protocol. At the time of hospital discharge, participating patients will be randomly placed on either celecoxib 200mg twice a day or a placebo twice a day.
This study will determine if the continued use of celecoxib for six weeks after total knee arthroplasty hospitalization will further decrease narcotic consumption, improve knee range of motion, improve ambulatory ability, and improve patient satisfaction over patients receiving celecoxib only during the acute hospitalization.
- Being tested
- Celecoxib
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis Joint Replacement Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Zimmer Biomet
- Responsible party
- Sponsor
- Investigators
- William C Schroer, MD, Principal investigator, St. Louis Joint Replacement Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00474773
- Sponsor's protocol ID
- GA3190YM
- Status last verified
- Jan 2010
- First submitted
- 15 May 2007
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post Hospital Administration of Celecoxib Following Minimally Invasive Knee Replacement Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00474773
- Acronym / sponsor ID
- GA3190YM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- St. Louis Joint Replacement InstituteUniversity, hospital or other
- Collaborators
- Pfizer, Zimmer Biomet
- Study start
- Jun 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 17 May 2007 (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.
This study will evaluate the benefits of continuing celecoxib through six weeks of total knee arthroplasty recovery. This is a randomized, double blind study with a group of approximately 130 primary total knee patients. All patients will receive celecoxib throughout their hospitalization as per current minimally invasive total knee arthroplasty protocol. At the time of hospital discharge, participating patients will be randomly placed on either celecoxib 200mg twice a day or a placebo twice a day.
This study will determine if the continued use of celecoxib for six weeks after total knee arthroplasty hospitalization will further decrease narcotic consumption, improve knee range of motion, improve ambulatory ability, and improve patient satisfaction over patients receiving celecoxib only during the acute hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- total knee canidates
Key inclusion criteria (4 listed)
- having undergone a minimally invasive total knee by select surgeon
- voluntarily enrolled
- independent community ambulators
- only patients being discharged directly home
Key exclusion criteria (9 listed)
- celecoxib allergy or intolerence
- Renal insufficiency (defined as serum creatine level >1.5 mg/dL or BUN level >22mg/dL
- History of bleeding gastic or duodenal ulceration
- New York Heart Association Class III or IV Congestive Heart Failure
- Previous myocardial infarction or cerebralvascular event
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celecoxib | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
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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.
William C Schroer, MD principal investigator
St. Louis Joint Replacement Institute
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 Pain Management and Function, run by St. Louis Joint Replacement Institute at 1 site in United States.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 28 Apr 2016. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 28 Apr 2016.