Clinical trial NCT01714999: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Laceration of the Olecranon or Prepatellar Bursa
Keywords: olecranon
prepatellar
bursa
trauma
laceration
bursectomy
bursa reconstruction
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2012-10-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Wound infection
timeFrame: 6 weeks
Secondary outcomes:
measure: Bursitis
timeFrame: 12 month
Other outcomes:
measure: Treatment costs of a standard patient
timeFrame: 6 weeks / 12 month
Locations:
city: Vienna
country: Austria
facility: Department of Trauma Surgery, Medical University of Vienna
city: Munich
country: Germany
facility: Department of Trauma Surgery, Medical University of Munich
Study officials:
affiliation: Ludwig-Maximilians - University of Munich
name: Sebastian F Baumbach, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ludwig-Maximilians - University of Munich
name: Vikoria Bogner, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.