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Status unknownNCT01714999Updated Apr 16, 2014

Treatment of Acute Traumatic Laceration of the Olecranon and Prepatellar Bursa

An interventional study of Bursectomy and Bursal reconstruction in Traumatic Laceration of the Olecranon or Prepatellar Bursa, sponsored by Ludwig-Maximilians - University of Munich. Status unknown at 2 sites in 2 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2014-04-16.

Sponsored by Ludwig-Maximilians - University of Munich · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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)

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.

  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)
02

Conditions studied

  • Traumatic Laceration of the Olecranon or Prepatellar Bursa

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Keywords

  • olecranon
  • prepatellar
  • bursa
  • trauma
  • laceration
  • bursectomy
  • bursa reconstruction
03

In context

Lacerations

133 studies on the registry are indexed under Lacerations; 29 are open to participants now.

This study's planned enrollment of 100 is above the median of 79 across 106 interventional studies indexed under Lacerations.

Browse Lacerations studies →

Lead sponsor

Ludwig-Maximilians - University of Munich is the lead sponsor of 218 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Acute lacerations of the OB or PB (\<12h)
  • Age 18 - 60 years
  • Patient can read and understand German

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureBursectomy

    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.

    Also known as: Removal of the Bursa, Excision of the Bursa

  • ProcedureBursal 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

    Also known as: Reconstruction of the bursa

06

What researchers measure

Primary outcomes

  1. Wound infection

    Time frame: 6 weeks

Secondary outcomes

  1. Bursitis

    Time frame: 12 month

Other outcomes

  1. Treatment costs of a standard patient

    Time frame: 6 weeks / 12 month

07

Study locations

2 of 2 sites recruiting
  • Department of Trauma Surgery, Medical University of Vienna
    Vienna, 1090, Austria
    Recruiting
  • Department of Trauma Surgery, Medical University of Munich
    Munich, 80336, Germany
    Recruiting
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01714999
Lead sponsor
Ludwig-Maximilians - University of Munich
Responsible party
Sebastian. F. Baumbach (M.D., Ludwig-Maximilians - University of Munich) — Principal investigator
First posted
Oct 26, 2012
Start date
Apr 2014
Primary completion
Sep 2015 (estimated)
Completion
Dec 2015 (estimated)
Last update
Apr 16, 2014

Study contacts

Sebastian F Baumbach, M.D.
Contact
sebastian.baumbach@med.uni-muenchen.de
Sebastian F Baumbach, MD
principal investigator · Ludwig-Maximilians - University of Munich
Vikoria Bogner, MD
principal investigator · Ludwig-Maximilians - University of Munich

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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