Treatment of Compound Tibia Fracture With a Microvascular Latissimus Dorsi Flap and the Ilizarov Technique

Reconstructive Surgical Procedure Clinical Trial

Official title:

Treatment of Compound Tibia Fracture With a Microvascular Latissimus Dorsi Flap and the Ilizarov Technique: a Cross-sectional Study of Long-term Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02369991
• Other study ID #: 343/13/03/02/2013/4
• Status: Completed
• Phase: N/A
• First received: February 18, 2015
• Last updated: May 12, 2015
• Start date: June 2014
• Est. completion date: February 2015

Study information

• Verified date: May 2015
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study assesses the long-term results of compound tibial reconstruction treated with a microvascular latissimus dorsi flap and bone transport technique during the last 25 year in Helsinki University central Hospital.

Description:

A retrospective review of hospital records was conducted to chart the clinical and operational characteristics of patient. Patients current condition is assessed by applying two function-related (Disabilities of the Arm, Hand and Shoulder, DASH; Lower Extremity Functional Scale, LEFS) and a health-related quality of life (the 15-dimensions, 15D) questionnaires. The patients received the questionnaires by mail. A written informed consent was obtained from the participants. The obtained data was computerized and analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Age over 15 years.

• Patients with acute compound tibial fracture or sequela treated with free latissimus dorsi flap and bone transport.

Exclusion Criteria:

• Deceased.

• Patients under 15 years of age.

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Reconstructive Surgical Procedure
• Tibial Fractures

Intervention

Procedure:
• Reconstructive surgery
Patients were treated with free latissimus dorsi flap and bone transport technique

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki	Uusimaa

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disabilities of the Arm, Shoulder and Hand (DASH)	Assesses the function of the donor site	10-25 years	No
Primary	The 15-Dimensions Health-Related Quality of Life (HRQoL) instrument.	Assesses the HRQoL	10-25 years	No
Primary	Lower Extremity Functional Scale (LEFS)	Assesses the function of the reconstructed limb	10-25 years	No