Traumatic Laceration of the Olecranon or Prepatellar BursaNCT01714999
Treatment of Acute Traumatic Laceration of the Olecranon and Prepatellar Bursa
A study testing Bursectomy and Bursal reconstruction in people with Traumatic Laceration of the Olecranon or Prepatellar Bursa, run by Ludwig-Maximilians - University of Munich at 2 sites in 2 countries.
Trial summary
Following a recent publication by the authors [1], there is no standardized treatment regime for the treatment of lacerations of the olecranon or prepatellar bursa, although primary bursectomy seems to be the most common treatment regime in Germany, Austria and Switzerland. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Traumatic Laceration of the Olecranon or Prepatellar Bursa
- What is being tested?
- Bursectomy and Bursal reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2014to Dec 2015
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Acute lacerations of the OB or PB (<12h)
- Age 18 - 60 years
- Patient can read and understand German
Who cannot join
- Immunodeficient patients
- Severe dementia
- Chronic alcoholism
- Conditions affecting the neuromuscular- or musculoskeletal system
- Previous surgical interventions at the same joint
- Conditions affecting wound healing (including chronic alcoholism, insulin dependent diabetes
Show all 10Show fewer
- Neurological diseases
- Patient is not available for follow-up visits
- Patient suspected to be non-compliant
- No major concomitant injuries
Trial locations and contacts
2 sites in 2 countries.
Sebastian F Baumbach, M.D. contact
2 sites in 2 countries
Austria1 site, 1 recruiting
- Recruiting
Department of Trauma Surgery, Medical University of Vienna
Vienna, 1090
Florian Domaszewski, M.D., florian.domaszewski@meduniwien.ac.at
Florian Domaszewski, M.D.
Germany1 site, 1 recruiting
- Recruiting
Department of Trauma Surgery, Medical University of Munich
Munich, 80336
Sebastian F. Baumbach, M.D., sebastian.baumbach@med.uni-muenchen.de
Sebastian F. Baumbach, M.D.
About this study
Official title: A Prospective Evaluation of the Current Treatment Regime for Acute Traumatic Laceration of the Olecranon and Prepatellar Bursa
Following a recent publication by the authors [1], there is no standardized treatment regime for the treatment of lacerations of the olecranon or prepatellar bursa, although primary bursectomy seems to be the most common treatment regime in Germany, Austria and Switzerland. The aim of this study is to prospectively follow patients who suffered from an acute traumatic laceration of the OB or PB treated, according to the local standards, either by bursectomy (Vie, AT) or bursal reconstruction and direct wound closure (Muc, GER).
[1] Baumbach et al. Evaluation of the current treatment concepts in Germany, Austria and Switzerland for acute traumatic lesions to the prepatellar and olecranon bursa. Injury (2012)
Read the detailed description
A fall onto the elbow or knee often results in a laceration of the olecranon (OB) and prepatellar bursa (PB), due to their exposed and superficial location. Although a common injury, the authors are not aware of any study dealing with this entity. In order to get a first idea on the treatment concepts currently used, the authors conducted a international online survey among orthopaedic and trauma surgeons in Germany, Austria and Switzerland [1]. The primary treatment approach of more than 70% of Austrian and German surgeons was bursectomy and immobilization, which was performed by less than 50% of Swiss physicians.
At the Departments of Trauma Surgery of the Medical University of Vienna and of the Medical University of Munich, two opposing treatment concepts are being practised. Whereas in Vienna a bursectomy is performed in case of traumatic laceration of the OB and PB, a primary bursal reconstruction is performed at the Medical University of Munich.
The aim of this study is to prospectively follow patients who suffered from an acute traumatic laceration of the OB or PB treated, according to the local standards, either by bursectomy (Vie, AT) or bursal reconstruction and direct wound closure (Muc, GER).
The Hypothesis of this study is, that there is no difference with respect to complications between bursectomy and bursal reconstruction in case of acute traumatic laceration of the OB and PB.
- Baumbach et al. Evaluation of the current treatment concepts in Germany, Austria and Switzerland for acute traumatic lesions to the prepatellar and olecranon bursa. Injury (2012)
- Being tested
- Bursectomy, Bursal reconstruction
- Keywords
- olecranon, prepatellar, bursa, trauma, laceration, bursectomy, bursa reconstruction
- Medical subject headings
- Wounds and Injuries, Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BursectomyProcedure or surgery
Also called Removal of the Bursa, Excision of the Bursa
Bursectomy of the OB and PB are performed in the operation theatre under sterile conditions. In case of a laceration of the OB a leash, in case of PB a redon drainage (Charr. 10) is inserted. After application of a sterile bandage a cast is applied in both cases. Patient will receive AB for 5 days, the affected limb will be immobilized until removal of the stiches after 12-14 days.
Bursal reconstructionProcedure or surgery
Also called Reconstruction of the bursa
The bursal laceration is treated within in ER setting. The wound is cleaned and thoroughly washed, if needed the wound margins are excised. The wound is then closed using simple suture and a plaster applied and removed 5 days later. Antibiotics are be administered for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Bursectomy: Vienna | Experimental | At the Department of Trauma Surgery, Medical University of Vienna, bursectomy is considered the gold standard in case of traumatic laceration of the OB or PB bursa. Receives: Procedure: Bursectomy |
| Bursal reconstruction: Munich | Experimental | At the Department of Trauma Surgery, Medical University of Munich, the treatment regime is a primary bursa-preserving therapy. Receives: Procedure: Bursal reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound infection
Measured: 6 weeks
Secondary outcomes (1)
Bursitis
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startApr 2014
- Primary completionSep 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Laceration of the Olecranon or Prepatellar BursaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian. F. Baumbach, Ludwig-Maximilians - University of Munich
- Investigators
- Sebastian F Baumbach, MD, Principal investigator, Ludwig-Maximilians - University of MunichVikoria Bogner, MD, Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714999
- Sponsor's protocol ID
- 415-12
- Other IDs
- 1692/2012
- Status last verified
- Apr 2014
- First submitted
- 24 Oct 2012
- Last updated
- 16 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Baumbach SF, Domaszewski F, Wyen H, Kalcher K, Mutschler W, Kanz KG. Evaluation of the current treatment concepts in Germany, Austria and Switzerland for acute traumatic lesions to the prepatellar and olecranon bursa. Injury. 2013 Nov;44(11):1423-7. doi: 10.1016/j.injury.2012.08.008. Epub 2012 Sep 11.
PubMed 22980398
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of the Current Treatment Regime for Acute Traumatic Laceration of the Olecranon and Prepatellar Bursa
- ClinicalTrials.gov ID
- NCT01714999
- Acronym / sponsor ID
- 415-12
- Keywords
- olecranon, prepatellar, bursa, trauma, laceration, bursectomy, bursa reconstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 26 Oct 2012 (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.
Following a recent publication by the authors [1], there is no standardized treatment regime for the treatment of lacerations of the olecranon or prepatellar bursa, although primary bursectomy seems to be the most common treatment regime in Germany, Austria and Switzerland. The aim of this study is to prospectively follow patients who suffered from an acute traumatic laceration of the OB or PB treated, according to the local standards, either by bursectomy (Vie, AT) or bursal reconstruction and direct wound closure (Muc, GER).
[1] Baumbach et al. Evaluation of the current treatment concepts in Germany, Austria and Switzerland for acute traumatic lesions to the prepatellar and olecranon bursa. Injury (2012)
Detailed description
A fall onto the elbow or knee often results in a laceration of the olecranon (OB) and prepatellar bursa (PB), due to their exposed and superficial location. Although a common injury, the authors are not aware of any study dealing with this entity. In order to get a first idea on the treatment concepts currently used, the authors conducted a international online survey among orthopaedic and trauma surgeons in Germany, Austria and Switzerland [1]. The primary treatment approach of more than 70% of Austrian and German surgeons was bursectomy and immobilization, which was performed by less than 50% of Swiss physicians.
At the Departments of Trauma Surgery of the Medical University of Vienna and of the Medical University of Munich, two opposing treatment concepts are being practised. Whereas in Vienna a bursectomy is performed in case of traumatic laceration of the OB and PB, a primary bursal reconstruction is performed at the Medical University of Munich.
The aim of this study is to prospectively follow patients who suffered from an acute traumatic laceration of the OB or PB treated, according to the local standards, either by bursectomy (Vie, AT) or bursal reconstruction and direct wound closure (Muc, GER).
The Hypothesis of this study is, that there is no difference with respect to complications between bursectomy and bursal reconstruction in case of acute traumatic laceration of the OB and PB.
- Baumbach et al. Evaluation of the current treatment concepts in Germany, Austria and Switzerland for acute traumatic lesions to the prepatellar and olecranon bursa. Injury (2012)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bursectomy: Vienna | Experimental | Procedure: BursectomyAt the Department of Trauma Surgery, Medical University of Vienna, bursectomy is considered the gold standard in case of traumatic laceration of the OB or PB bursa. |
| Bursal reconstruction: Munich | Experimental | Procedure: Bursal reconstructionAt the Department of Trauma Surgery, Medical University of Munich, the treatment regime is a primary bursa-preserving therapy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Acute lacerations of the OB or PB (<12h)
- Age 18 - 60 years
- Patient can read and understand German
Key exclusion criteria (10 listed)
- Immunodeficient patients
- Severe dementia
- Chronic alcoholism
- Conditions affecting the neuromuscular- or musculoskeletal system
- Previous surgical interventions at the same joint
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 |
|---|---|---|
| BursectomyAlso: Removal of the Bursa, Excision of the BursaBursectomy of the OB and PB are performed in the operation theatre under sterile conditions. In case of a laceration of the OB a leash, in case of PB a redon drainage (Charr. 10) is inserted. After application of a sterile bandage a cast is applied in both cases. Patient will receive AB for 5 days, the affected limb will be immobilized until removal of the stiches after 12-14 days. | Procedure or surgery | Bursectomy: Vienna |
| Bursal reconstructionAlso: Reconstruction of the bursaThe bursal laceration is treated within in ER setting. The wound is cleaned and thoroughly washed, if needed the wound margins are excised. The wound is then closed using simple suture and a plaster applied and removed 5 days later. Antibiotics are be administered for 5 days | Procedure or surgery | Bursal reconstruction: Munich |
Primary outcome
Wound infection
Time frame: 6 weeks
1 secondary outcome
Bursitis
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2014.
- Background: PubMed 22980398Baumbach SF, Domaszewski F, Wyen H, Kalcher K, Mutschler W, Kanz KG. Evaluation of the current treatment concepts in Germany, Austria and Switzerland for acute traumatic lesions to the prepatellar and olecranon bursa. Injury. 2013 Nov;44(11):1423-7. doi: 10.1016/j.injury.2012.08.008. Epub 2012 Sep 11.
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.
Sebastian F Baumbach, M.D. contact
Sebastian F Baumbach, MD principal investigator
Ludwig-Maximilians - University of Munich
Vikoria Bogner, MD principal investigator
Ludwig-Maximilians - University of Munich
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bursectomy and Bursal reconstruction in people with Traumatic Laceration of the Olecranon or Prepatellar Bursa, run by Ludwig-Maximilians - University of Munich at 2 sites in 2 countries.
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 3 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 16 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Germany. 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?
Contact Sebastian F Baumbach, M.D. (sebastian.baumbach@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound infection (time frame: 6 weeks). 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 NCT01714999, which also lists 1 linked publication.
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 16 Apr 2014.