Treatment of Acute Traumatic Laceration of the Olecranon and Prepatellar Bursa

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)

Study Overview

• Status: Unknown
• Conditions: Traumatic Laceration of the Olecranon or Prepatellar Bursa
• Intervention / Treatment: Procedure: Bursectomy; Procedure: Bursal reconstruction

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)

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sebastian F Baumbach, M.D.; Email: sebastian.baumbach@med.uni-muenchen.de

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Department of Trauma Surgery, Medical University of Vienna
    • Contact: Florian Domaszewski, M.D.; Email: florian.domaszewski@meduniwien.ac.at
    • Principal Investigator: Florian Domaszewski, M.D.
• Germany
  • Munich, Germany, 80336
    • Recruiting
    • Department of Trauma Surgery, Medical University of Munich
    • Contact: Sebastian F. Baumbach, M.D.; Email: sebastian.baumbach@med.uni-muenchen.de
    • Principal Investigator: Sebastian F. Baumbach, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bursectomy: Vienna; 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.	Procedure: Bursectomy; 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.; Other Names: Removal of the Bursa, Excision of the Bursa
Experimental: Bursal reconstruction: Munich; At the Department of Trauma Surgery, Medical University of Munich, the treatment regime is a primary bursa-preserving therapy.	Procedure: Bursal reconstruction; 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; Other Names: Reconstruction of the bursa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Wound infection	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Bursitis	12 month

Other Outcome Measures

Outcome Measure	Time Frame
Treatment costs of a standard patient	6 weeks / 12 month

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Investigators: Principal Investigator: Sebastian F Baumbach, MD, Ludwig-Maximilians - University of Munich; Principal Investigator: Vikoria Bogner, MD, Ludwig-Maximilians - University of Munich

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: October 24, 2012
• First Submitted That Met QC Criteria: October 24, 2012
• First Posted (Estimate): October 26, 2012

Study Record Updates

• Last Update Posted (Estimate): April 16, 2014
• Last Update Submitted That Met QC Criteria: April 14, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: trauma; bursectomy; olecranon; prepatellar; bursa; laceration; bursa reconstruction
• Additional Relevant MeSH Terms: Wounds and Injuries; Lacerations
• Other Study ID Numbers: 415-12; 1692/2012 (Other Identifier: Ethics commission Medical University of Vienna)