Treatment of Acute Traumatic Laceration of the Olecranon and Prepatellar Bursa

Traumatic Laceration of the Olecranon or Prepatellar Bursa Clinical Trial

Official title:

A Prospective Evaluation of the Current Treatment Regime for Acute Traumatic Laceration of the Olecranon and Prepatellar Bursa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01714999
• Other study ID #: 415-12
• Secondary ID: 1692/2012
• Status: Recruiting
• Phase: N/A
• First received: October 24, 2012
• Last updated: April 14, 2014
• Start date: April 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2014
• Source: Ludwig-Maximilians - University of Munich
• Contact: Sebastian F Baumbach, M.D.
• Email: sebastian.baumbach[@]med.uni-muenchen.de
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionAustria: Ethikkommission
• Study type: Interventional

Clinical Trial 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)

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lacerations
• Traumatic Laceration of the Olecranon or Prepatellar Bursa

Intervention

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.
• 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

Locations

Country	Name	City	State
Austria	Department of Trauma Surgery, Medical University of Vienna	Vienna
Germany	Department of Trauma Surgery, Medical University of Munich	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Countries where clinical trial is conducted

Austria,  Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment costs of a standard patient		6 weeks / 12 month	No
Primary	Wound infection		6 weeks	No
Secondary	Bursitis		12 month	No