Treatment of Acute Traumatic Laceration of the Olecranon and Prepatellar Bursa
Primary Purpose
Traumatic Laceration of the Olecranon or Prepatellar Bursa
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Bursectomy
Bursal reconstruction
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Laceration of the Olecranon or Prepatellar Bursa focused on measuring olecranon, prepatellar, bursa, trauma, laceration, bursectomy, bursa reconstruction
Eligibility Criteria
Inclusion Criteria:
- Acute lacerations of the OB or PB (<12h)
- Age 18 - 60 years
- Patient can read and understand German
Exclusion Criteria:
- 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
- Neurological diseases
- Patient is not available for follow-up visits
- Patient suspected to be non-compliant
- No major concomitant injuries
Sites / Locations
- Department of Trauma Surgery, Medical University of ViennaRecruiting
- Department of Trauma Surgery, Medical University of MunichRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Bursectomy: Vienna
Bursal reconstruction: Munich
Arm Description
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.
At the Department of Trauma Surgery, Medical University of Munich, the treatment regime is a primary bursa-preserving therapy.
Outcomes
Primary Outcome Measures
Wound infection
Secondary Outcome Measures
Bursitis
Full Information
NCT ID
NCT01714999
First Posted
October 24, 2012
Last Updated
April 14, 2014
Sponsor
Ludwig-Maximilians - University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT01714999
Brief Title
Treatment of Acute Traumatic Laceration of the Olecranon and Prepatellar Bursa
Official Title
A Prospective Evaluation of the Current Treatment Regime for Acute Traumatic Laceration of the Olecranon and Prepatellar Bursa
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig-Maximilians - University of Munich
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Laceration of the Olecranon or Prepatellar Bursa
Keywords
olecranon, prepatellar, bursa, trauma, laceration, bursectomy, bursa reconstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bursectomy: Vienna
Arm Type
Experimental
Arm Description
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.
Arm Title
Bursal reconstruction: Munich
Arm Type
Experimental
Arm Description
At the Department of Trauma Surgery, Medical University of Munich, the treatment regime is a primary bursa-preserving therapy.
Intervention Type
Procedure
Intervention Name(s)
Bursectomy
Other Intervention Name(s)
Removal of the Bursa, Excision of the Bursa
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Bursal reconstruction
Other Intervention Name(s)
Reconstruction of the bursa
Intervention Description
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
Primary Outcome Measure Information:
Title
Wound infection
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Bursitis
Time Frame
12 month
Other Pre-specified Outcome Measures:
Title
Treatment costs of a standard patient
Time Frame
6 weeks / 12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acute lacerations of the OB or PB (<12h)
Age 18 - 60 years
Patient can read and understand German
Exclusion Criteria:
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
Neurological diseases
Patient is not available for follow-up visits
Patient suspected to be non-compliant
No major concomitant injuries
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sebastian F Baumbach, M.D.
Email
sebastian.baumbach@med.uni-muenchen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian F Baumbach, MD
Organizational Affiliation
Ludwig-Maximilians - University of Munich
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vikoria Bogner, MD
Organizational Affiliation
Ludwig-Maximilians - University of Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Trauma Surgery, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florian Domaszewski, M.D.
Email
florian.domaszewski@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Florian Domaszewski, M.D.
Facility Name
Department of Trauma Surgery, Medical University of Munich
City
Munich
ZIP/Postal Code
80336
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastian F. Baumbach, M.D.
Email
sebastian.baumbach@med.uni-muenchen.de
First Name & Middle Initial & Last Name & Degree
Sebastian F. Baumbach, M.D.
12. IPD Sharing Statement
Citations:
PubMed Identifier
22980398
Citation
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.
Results Reference
background
Learn more about this trial
Treatment of Acute Traumatic Laceration of the Olecranon and Prepatellar Bursa
We'll reach out to this number within 24 hrs