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Treatment of Acute Traumatic Laceration of the Olecranon and Prepatellar Bursa

This study is not yet open for participant recruitment.
Verified October 2012 by Ludwig-Maximilians - University of Munich
Sponsor:
Information provided by (Responsible Party):
Sebastian. F. Baumbach, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01714999
First received: October 24, 2012
Last updated: October 26, 2012
Last verified: October 2012
History of Changes
  Purpose

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)


Condition Intervention
Traumatic Laceration of the Olecranon or Prepatellar Bursa
 Procedure: Bursectomy
Procedure: Bursal reconstruction

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Evaluation of the Current Treatment Regime for Acute Traumatic Laceration of the Olecranon and Prepatellar Bursa

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • Wound infection [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bursitis [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Treatment costs of a standard patient [ Time Frame: 6 weeks / 12 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Reconstruction of the bursa

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01714999

Contacts
Contact: Sebastian F Baumbach, M.D. sebastian.baumbach@med.uni-muenchen.de

Locations
Austria
Department of Trauma Surgery, Medical University of Vienna Active, not recruiting
Vienna, Austria, 1090
Germany
Department of Trauma Surgery, Medical University of Munich Active, not recruiting
Munich, Germany, 80336
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
Principal Investigator: Karl-Georg Kanz, P.D. Ludwig-Maximilians - University of Munich
  More Information

Publications:

Responsible Party: Sebastian. F. Baumbach, M.D., Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01714999     History of Changes
Other Study ID Numbers: 415-12, 1692/2012
Study First Received: October 24, 2012
Last Updated: October 26, 2012
Health Authority: Germany: Ethics Commission
Austria: Ethikkommission

Keywords provided by Ludwig-Maximilians - University of Munich:
olecranon
prepatellar
bursa
trauma
 laceration
bursectomy
bursa reconstruction

Additional relevant MeSH terms:
Lacerations
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013