Treatment of Compound Tibia Fracture With a Microvascular... | NCT02369991

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

NCT02369991

Sponsor

Helsinki University Central Hospital

Status

Completed

Last Update Posted

May 14, 2015Estimated

Enrollment

9Actual

Phase

Not provided

Conditions

Reconstructive Surgical Procedure

Interventions

Reconstructive surgery

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Feb 2015Actual

Completion Date

Feb 2015Actual

First Submitted Date

Feb 18, 2015

First Submission Date that Met QC Criteria

Feb 23, 2015

First Posted Date

Feb 24, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2015

Last Update Posted Date

May 14, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jussi Repo, Researcher, Helsinki University Central HospitalPrincipal Investigator

Lead Sponsor

Helsinki University Central HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Reconstructive surgery	Procedure	Patients were treated with free latissimus dorsi flap and bone transport technique

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erkki J. Tukiainen, PhD, MD	Helsinki University Hospital, Department of Plastic and Reconstructive Surgery.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki University Central Hospital		Helsinki	Uusimaa	00029	Finland

Condition Browse Module

MeSH Terms

ID	Term
D013978	Tibial Fractures

Ancestor Terms

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries
D007869	Leg Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019651	Plastic Surgery Procedures

Ancestor Terms

ID	Term
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided