NCT02369991

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2015

Completed
Last Updated

May 14, 2015

Status Verified

May 1, 2015

Enrollment Period

8 months

First QC Date

February 18, 2015

Last Update Submit

May 12, 2015

Conditions

Reconstructive Surgical Procedure

Keywords

latissimus dorsi flapbone transportbone reconstructiontibiatibial fracture

Outcome Measures

Primary Outcomes (3)

  • Disabilities of the Arm, Shoulder and Hand (DASH)

    Assesses the function of the donor site

    10-25 years

  • The 15-Dimensions Health-Related Quality of Life (HRQoL) instrument.

    Assesses the HRQoL

    10-25 years

  • Lower Extremity Functional Scale (LEFS)

    Assesses the function of the reconstructed limb

    10-25 years

Interventions

Reconstructive surgeryPROCEDURE

Patients were treated with free latissimus dorsi flap and bone transport technique

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age over 15 years.
  • Patients with acute compound tibial fracture or sequela treated with free latissimus dorsi flap and bone transport.

You may not qualify if:

  • Deceased.
  • Patients under 15 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Central Hospital

Helsinki, Uusimaa, 00029, Finland

Location

MeSH Terms

Conditions

Tibial Fractures

Interventions

Plastic Surgery Procedures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Erkki J. Tukiainen, PhD, MD

    Helsinki University Hospital, Department of Plastic and Reconstructive Surgery.

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

February 18, 2015

First Posted

February 24, 2015

Study Start

June 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

May 14, 2015

Record last verified: 2015-05

Locations

FI(1)