Olecranon BursitisNCT01406652
Optimisation of the Treatment of Infectious Bursitis
A study testing Two-stage bursectomy in people with Olecranon Bursitis and Patellar Bursitis, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The study investigates prospectively the cost-savings related to a one-stage bursectomy (debridement, drainage and closure at the same time) versus two-stage bursectomy (debridement, left open and closure at a second time) of severe bursitis among hospitalized patients for surgical treatment of septic bursitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Olecranon Bursitis, Patellar Bursitis
- What is being tested?
- Two-stage bursectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2011to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Hospitalized for bursectomy for septic bursitis
Who cannot join
- Bacteraemic diseases
- Presence of another concomitant infection requiring antibiotics
- Presence of osteosynthesis material beneath the bursitis
- Septic bursitis outside of the elbow or the knee
- Severe immune suppression (transplantation, HIV with Cluster of Differentiation cell count <200 cells/mm3, immune suppressive treatment with equivalence of more than 15 mg of prednisone daily ).
- Recurrent septic bursitis episodes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: One-stage Versus Two-stage Surgical Treatment of Infectious Bursitis
The study investigates prospectively the cost-savings related to a one-stage bursectomy (debridement, drainage and closure at the same time) versus two-stage bursectomy (debridement, left open and closure at a second time) of severe bursitis among hospitalized patients for surgical treatment of septic bursitis.
We suppose that the one-stage bursectomy reveals similar recurrence rates but is associated with a significant shortening of hospital stay, consumption of resources and increased patient satisfaction.
Read the detailed description
Start as single center interventional study at Geneva University Hospitals Study open for additional centres (electronic CRF) Funding on 24.6.2011 (50,000 Swiss Francs). Further demand for funding ongoing.
Septic bursitis of knee and elbows, for which the patients are hospitalised (a substantial part of patient with failure of conservative treatment) Randomisation 1:1 (one-stage vs. two-stage).
Duration of concomitant postsurgical antibiotic therapy fixed to 7 days Exclusion of severely immuno-depressed patients.
Assessment of all costs of inpatient treatment and outpatient follow-up of included cases.
Interim analysis after ca. 100 cases planified.
- Conditions
- Olecranon Bursitis, Patellar Bursitis
- Being tested
- Two-stage bursectomy
- Keywords
- septic bursitis, bursectomy, primary closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-stage bursectomyProcedure or surgery
Also called There are no "other names"
Debridement, drainage, and secondary closure of septic bursitis during two surgical interventions
| Study group | Role | What they receive |
|---|---|---|
| One-stage bursectomy | Active comparator | Bursectomy with debridement and primary closure of the wound during one surgical intervention Receives: Procedure: Two-stage bursectomy |
| Two-stage bursectomy | Experimental | Bursectomy with debridement and left open. Wound closure in a second step and in a second surgery. Receives: Procedure: Two-stage bursectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Costs of the Combined Surgical and Medical Treatment
The overall costs are of primary interest in the study protocol.
Measured: 2 months
Secondary outcomes (1)
Number of Participants With Post-surgical Wound Dehiscence
We assess clinical failures of bursectomy for bursitis. As recurrences are associated with wound dehiscence, we evaluate the dehiscence a the most important parameter for Failure. Of course, dehiscence can also occur without recurrent infection, but this is also considered as failure.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startMay 2011
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Olecranon BursitisStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Randomization 1:1 with two arms: One versus two-stage bursectomy.
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilker Uckay, University Hospital, Geneva
- Investigators
- Ilker UCKAY, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406652
- Sponsor's protocol ID
- 11-016 (NAC 11-004)
- Status last verified
- Nov 2019
- First submitted
- 27 Jun 2011
- Last updated
- 2 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Perez C, Huttner A, Assal M, Bernard L, Lew D, Hoffmeyer P, Uckay I. Infectious olecranon and patellar bursitis: short-course adjuvant antibiotic therapy is not a risk factor for recurrence in adult hospitalized patients. J Antimicrob Chemother. 2010 May;65(5):1008-14. doi: 10.1093/jac/dkq043. Epub 2010 Mar 1.
PubMed 20197288Uckay I, von Dach E, Perez C, Agostinho A, Garnerin P, Lipsky BA, Hoffmeyer P, Pittet D. One- vs 2-Stage Bursectomy for Septic Olecranon and Prepatellar Bursitis: A Prospective Randomized Trial. Mayo Clin Proc. 2017 Jul;92(7):1061-1069. doi: 10.1016/j.mayocp.2017.03.011. Epub 2017 Jun 8.
PubMed 28602435Baumbach SF, Wyen H, Perez C, Kanz KG, Uckay I. Evaluation of current treatment regimens for prepatellar and olecranon bursitis in Switzerland. Eur J Trauma Emerg Surg. 2013 Feb;39(1):65-72. doi: 10.1007/s00068-012-0236-4. Epub 2012 Nov 8.
PubMed 26814924
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-stage Versus Two-stage Surgical Treatment of Infectious Bursitis
- ClinicalTrials.gov ID
- NCT01406652
- Acronym / sponsor ID
- 11-016 (NAC 11-004)
- Conditions
- Olecranon Bursitis, Patellar Bursitis
- Keywords
- septic bursitis, bursectomy, primary closure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 1 Aug 2011 (estimated)
- Results
- Posted 5 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study investigates prospectively the cost-savings related to a one-stage bursectomy (debridement, drainage and closure at the same time) versus two-stage bursectomy (debridement, left open and closure at a second time) of severe bursitis among hospitalized patients for surgical treatment of septic bursitis.
We suppose that the one-stage bursectomy reveals similar recurrence rates but is associated with a significant shortening of hospital stay, consumption of resources and increased patient satisfaction.
Detailed description
Start as single center interventional study at Geneva University Hospitals Study open for additional centres (electronic CRF) Funding on 24.6.2011 (50,000 Swiss Francs). Further demand for funding ongoing.
Septic bursitis of knee and elbows, for which the patients are hospitalised (a substantial part of patient with failure of conservative treatment) Randomisation 1:1 (one-stage vs. two-stage).
Duration of concomitant postsurgical antibiotic therapy fixed to 7 days Exclusion of severely immuno-depressed patients.
Assessment of all costs of inpatient treatment and outpatient follow-up of included cases.
Interim analysis after ca. 100 cases planified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization 1:1 with two arms: One versus two-stage bursectomy.
| Arm | Type | Receives |
|---|---|---|
| One-stage bursectomy | Active comparator | Procedure: Two-stage bursectomyBursectomy with debridement and primary closure of the wound during one surgical intervention |
| Two-stage bursectomy | Experimental | Procedure: Two-stage bursectomyBursectomy with debridement and left open. Wound closure in a second step and in a second surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18 years
- Hospitalized for bursectomy for septic bursitis
Key exclusion criteria (6 listed)
- Bacteraemic diseases
- Presence of another concomitant infection requiring antibiotics
- Presence of osteosynthesis material beneath the bursitis
- Septic bursitis outside of the elbow or the knee
- Severe immune suppression (transplantation, HIV with Cluster of Differentiation cell count <200 cells/mm3, immune suppressive treatment with equivalence of more than 15 mg of prednisone daily ).
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 |
|---|---|---|
| Two-stage bursectomyAlso: There are no "other names"Debridement, drainage, and secondary closure of septic bursitis during two surgical interventions | Procedure or surgery | One-stage bursectomy, Two-stage bursectomy |
Primary outcome
Overall Costs of the Combined Surgical and Medical Treatment
Time frame: 2 months
The overall costs are of primary interest in the study protocol.
1 secondary outcome
Number of Participants With Post-surgical Wound Dehiscence
Time frame: 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20197288Perez C, Huttner A, Assal M, Bernard L, Lew D, Hoffmeyer P, Uckay I. Infectious olecranon and patellar bursitis: short-course adjuvant antibiotic therapy is not a risk factor for recurrence in adult hospitalized patients. J Antimicrob Chemother. 2010 May;65(5):1008-14. doi: 10.1093/jac/dkq043. Epub 2010 Mar 1.
- Background: PubMed 28602435Uckay I, von Dach E, Perez C, Agostinho A, Garnerin P, Lipsky BA, Hoffmeyer P, Pittet D. One- vs 2-Stage Bursectomy for Septic Olecranon and Prepatellar Bursitis: A Prospective Randomized Trial. Mayo Clin Proc. 2017 Jul;92(7):1061-1069. doi: 10.1016/j.mayocp.2017.03.011. Epub 2017 Jun 8.
- Background: PubMed 26814924Baumbach SF, Wyen H, Perez C, Kanz KG, Uckay I. Evaluation of current treatment regimens for prepatellar and olecranon bursitis in Switzerland. Eur J Trauma Emerg Surg. 2013 Feb;39(1):65-72. doi: 10.1007/s00068-012-0236-4. Epub 2012 Nov 8.
- Individual participant dataSharing planned: No
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.
Ilker UCKAY, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two-stage bursectomy in people with Olecranon Bursitis and Patellar Bursitis, run by University Hospital, Geneva at 1 site in Switzerland.
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 2 inclusion and 6 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 2 Dec 2019. 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 Switzerland. 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?
Yes. Results are posted in the registry (first posted 5 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Costs of the Combined Surgical and Medical Treatment (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01406652, which also lists 3 linked publications.
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 2 Dec 2019.