Reverse or Primary Total ShoulderPhase 4NCT03305068
Evaluation of Post-Procedure Administration of Celecoxib Following Shoulder Surgery
A Phase 4 study testing Celecoxib in people with Reverse or Primary Total Shoulder and Rotator Cuff- Full Thickness- Repair, run by St. Louis Joint Replacement Institute at 1 site in United States.
Trial summary
Hypothesis It is expected that shoulder surgery patients treated with celecoxib (Celebrex) will experience significantly reduced narcotic use as measured by pill count compared with controls at three and six weeks postoperatively. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Reverse or Primary Total Shoulder, Rotator Cuff- Full Thickness- Repair
- What is being tested?
- Celecoxib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Jun 2018
- Phase
- Phase 4
- 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
Who may be able to join
- community ambulators
- D/C to home only
- only MO and IL pts
- Primary unilateral shoulder replacements / Cuff tear
- Full Thickness, single tendon tear
Who cannot join
- allergy, sensitivity, or inability to take Celebrex
- CR >1.5
- h/o bleeding ulcers
- h/o Inflammatory bowel disease, Crohn's disease, ulcerative colitis
- Coagulation abnormality
- Coumadin/Plavix/Xaralto
Show all 10Show fewer
- CHF
- Previous MI or CVA
- Current use of long acting narcotics (Fentanyl Patches, Oxycontin CR, MS Contin)
- Refusal by PCP or cardiologist
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Post-Procedure Administration of Celecoxib Following Shoulder Surgery: A Randomized Controlled Study
Hypothesis It is expected that shoulder surgery patients treated with celecoxib (Celebrex) will experience significantly reduced narcotic use as measured by pill count compared with controls at three and six weeks postoperatively.
Study Overview The proposed study will determine if there is benefit to the use of a COX-II inhibitor in shoulder surgery. This study will have two arms: Arm 1 (shoulder replacement, both primary and reverse) and Arm 2 (arthroscopic rotator cuff repair). These distinct arms are necessary because each surgery is distinct in terms of type of procedure, indications, and patient population. The patients in Arm 1 will undergo stratified randomization according to the type of arthroplasty (primary or reverse) to ensure a balanced representation of these patients within subgroups. All patients undergoing primary total shoulder replacement, reverse shoulder replacement, or arthroscopic rotator cuff repair will be eligible to participate in the appropriate arm of the study. Revision surgery patients will be excluded from both arms of the study. A maximum of 78 arthroscopic cuff repair patients, and 78 arthroplasty patients will be enrolled in each arm of the study. Baseline information will be obtained on each patient including baseline VAS for pain, baseline shoulder scores as outlined below, and baseline narcotic and anti-inflammatory medication use, if any. Patients will be randomized to receive celecoxib (Celebrex) 400 mg one hour prior to surgery or placebo; they will then continue to receive the same medication daily for 3 weeks postoperatively: celecoxib 200 mg twice daily or a placebo control. The primary outcome measure will be narcotic utilization as measured by narcotic pill count. Secondary outcome measures will include subjective measure of pain as measured by the VAS for pain, range of motion as measured by active forward elevation (at 6 weeks postoperatively) and three patient assessment scores: the Simple Shoulder Test (SST), the UCLA score, and the American Shoulder and Elbow Society score (ASES). Data will be obtained at follow-up visits three and six weeks postoperatively.
Read the detailed description
Hypothesis It is expected that shoulder surgery patients treated with celecoxib (Celebrex) will experience significantly reduced narcotic use as measured by pill count compared with controls at three and six weeks postoperatively.
Study Overview The proposed study will determine if there is benefit to the use of a COX-II inhibitor in shoulder surgery. This study will have two arms: Arm 1 (shoulder replacement, both primary and reverse) and Arm 2 (arthroscopic rotator cuff repair). These distinct arms are necessary because each surgery is distinct in terms of type of procedure, indications, and patient population. The patients in Arm 1 will undergo stratified randomization according to the type of arthroplasty (primary or reverse) to ensure a balanced representation of these patients within subgroups. All patients undergoing primary total shoulder replacement, reverse shoulder replacement, or arthroscopic rotator cuff repair will be eligible to participate in the appropriate arm of the study. Revision surgery patients will be excluded from both arms of the study. A maximum of 78 arthroscopic cuff repair patients, and 78 arthroplasty patients will be enrolled in each arm of the study. Baseline information will be obtained on each patient including baseline VAS for pain, baseline shoulder scores as outlined below, and baseline narcotic and anti-inflammatory medication use, if any. Patients will be randomized to receive celecoxib (Celebrex) 400 mg one hour prior to surgery or placebo; they will then continue to receive the same medication daily for 3 weeks postoperatively: celecoxib 200 mg twice daily or a placebo control. The primary outcome measure will be narcotic utilization as measured by narcotic pill count. Secondary outcome measures will include subjective measure of pain as measured by the VAS for pain, range of motion as measured by active forward elevation (at 6 weeks postoperatively) and three patient assessment scores: the Simple Shoulder Test (SST), the UCLA score, and the American Shoulder and Elbow Society score (ASES). Data will be obtained at follow-up visits three and six weeks postoperatively.
- Being tested
- Celecoxib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
| Study group | Role | What they receive |
|---|---|---|
| the use of a COX-II inhibitor in shoulder surgery. | Placebo comparator | Arm 1 shoulder replacement, both primary and reverse Receives: Drug: Celecoxib |
| the use of a COX-II inhibitor in arhroscopic shoulder surgery. | Placebo comparator | Arm 2 arthroscopic rotator cuff repair Receives: Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
This study will determine if use of celecoxib (Celebrex) for three weeks after shoulder surgery will reduce pain as measured by decreased narcotic consumption.
Measured: 3 weeks
This study will determine if use of celecoxib (Celebrex) for three weeks after shoulder surgery will reduce pain as measured by decreased narcotic consumption.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study startFeb 2014
- Primary completionMar 2018
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reverse or Primary Total ShoulderStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Louis Joint Replacement Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine Burns, MD, Principal investigator, SSM orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305068
- Sponsor's protocol ID
- BI177194
- Status last verified
- Apr 2018
- First submitted
- 7 Feb 2014
- Last updated
- 27 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-Procedure Administration of Celecoxib Following Shoulder Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03305068
- Acronym / sponsor ID
- BI177194
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- St. Louis Joint Replacement InstituteUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Mar 2018 (actual)
- Study completion
- Jun 2018 (estimated)
- First posted
- 9 Oct 2017 (actual)
- 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.
Hypothesis It is expected that shoulder surgery patients treated with celecoxib (Celebrex) will experience significantly reduced narcotic use as measured by pill count compared with controls at three and six weeks postoperatively.
Study Overview The proposed study will determine if there is benefit to the use of a COX-II inhibitor in shoulder surgery. This study will have two arms: Arm 1 (shoulder replacement, both primary and reverse) and Arm 2 (arthroscopic rotator cuff repair). These distinct arms are necessary because each surgery is distinct in terms of type of procedure, indications, and patient population. The patients in Arm 1 will undergo stratified randomization according to the type of arthroplasty (primary or reverse) to ensure a balanced representation of these patients within subgroups. All patients undergoing primary total shoulder replacement, reverse shoulder replacement, or arthroscopic rotator cuff repair will be eligible to participate in the appropriate arm of the study. Revision surgery patients will be excluded from both arms of the study. A maximum of 78 arthroscopic cuff repair patients, and 78 arthroplasty patients will be enrolled in each arm of the study. Baseline information will be obtained on each patient including baseline VAS for pain, baseline shoulder scores as outlined below, and baseline narcotic and anti-inflammatory medication use, if any. Patients will be randomized to receive celecoxib (Celebrex) 400 mg one hour prior to surgery or placebo; they will then continue to receive the same medication daily for 3 weeks postoperatively: celecoxib 200 mg twice daily or a placebo control. The primary outcome measure will be narcotic utilization as measured by narcotic pill count. Secondary outcome measures will include subjective measure of pain as measured by the VAS for pain, range of motion as measured by active forward elevation (at 6 weeks postoperatively) and three patient assessment scores: the Simple Shoulder Test (SST), the UCLA score, and the American Shoulder and Elbow Society score (ASES). Data will be obtained at follow-up visits three and six weeks postoperatively.
Detailed description
Hypothesis It is expected that shoulder surgery patients treated with celecoxib (Celebrex) will experience significantly reduced narcotic use as measured by pill count compared with controls at three and six weeks postoperatively.
Study Overview The proposed study will determine if there is benefit to the use of a COX-II inhibitor in shoulder surgery. This study will have two arms: Arm 1 (shoulder replacement, both primary and reverse) and Arm 2 (arthroscopic rotator cuff repair). These distinct arms are necessary because each surgery is distinct in terms of type of procedure, indications, and patient population. The patients in Arm 1 will undergo stratified randomization according to the type of arthroplasty (primary or reverse) to ensure a balanced representation of these patients within subgroups. All patients undergoing primary total shoulder replacement, reverse shoulder replacement, or arthroscopic rotator cuff repair will be eligible to participate in the appropriate arm of the study. Revision surgery patients will be excluded from both arms of the study. A maximum of 78 arthroscopic cuff repair patients, and 78 arthroplasty patients will be enrolled in each arm of the study. Baseline information will be obtained on each patient including baseline VAS for pain, baseline shoulder scores as outlined below, and baseline narcotic and anti-inflammatory medication use, if any. Patients will be randomized to receive celecoxib (Celebrex) 400 mg one hour prior to surgery or placebo; they will then continue to receive the same medication daily for 3 weeks postoperatively: celecoxib 200 mg twice daily or a placebo control. The primary outcome measure will be narcotic utilization as measured by narcotic pill count. Secondary outcome measures will include subjective measure of pain as measured by the VAS for pain, range of motion as measured by active forward elevation (at 6 weeks postoperatively) and three patient assessment scores: the Simple Shoulder Test (SST), the UCLA score, and the American Shoulder and Elbow Society score (ASES). Data will be obtained at follow-up visits three and six weeks postoperatively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the use of a COX-II inhibitor in shoulder surgery. | Placebo comparator | Drug: CelecoxibArm 1 shoulder replacement, both primary and reverse |
| the use of a COX-II inhibitor in arhroscopic shoulder surgery. | Placebo comparator | Drug: CelecoxibArm 2 arthroscopic rotator cuff repair |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- community ambulators
- D/C to home only
- only MO and IL pts
- Primary unilateral shoulder replacements / Cuff tear
- Full Thickness, single tendon tear
Key exclusion criteria (10 listed)
- allergy, sensitivity, or inability to take Celebrex
- CR >1.5
- h/o bleeding ulcers
- h/o Inflammatory bowel disease, Crohn's disease, ulcerative colitis
- Coagulation abnormality
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 | the use of a COX-II inhibitor in arhroscopic shoulder surgery., the use of a COX-II inhibitor in shoulder surgery. |
Primary outcome
This study will determine if use of celecoxib (Celebrex) for three weeks after shoulder surgery will reduce pain as measured by decreased narcotic consumption.
Time frame: 3 weeks
This study will determine if use of celecoxib (Celebrex) for three weeks after shoulder surgery will reduce pain as measured by decreased narcotic consumption.
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
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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.
Katherine Burns, MD principal investigator
SSM orthopedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Celecoxib in people with Reverse or Primary Total Shoulder and Rotator Cuff- Full Thickness- Repair, 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 5 inclusion and 10 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 27 Apr 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
This study will determine if use of celecoxib (Celebrex) for three weeks after shoulder surgery will reduce pain as measured by decreased narcotic consumption. (time frame: 3 weeks). The study lists 2 primary outcomes in all. 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 27 Apr 2018.