NCT01779011

Brief Summary

The prospective cohort study, SuTra2, assesses the functional and socio-economic status of patients who were operated on for a severe limb injury resulting in amputation or limb preservation 1 and 2 years after the 2010 Haiti earthquake.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
305

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
Last Updated

January 29, 2013

Status Verified

January 1, 2013

Enrollment Period

1.3 years

First QC Date

December 15, 2012

Last Update Submit

January 28, 2013

Conditions

Wounds and InjuriesTraumatic Amputation

Outcome Measures

Primary Outcomes (1)

  • Patient Satisfaction with Musculoskeletal functional recovery

    2 years

Secondary Outcomes (1)

  • Employment status

    2 years

Study Arms (2)

A cohort post amputation

Those patients undergoing either traumatic amputation or surgical amputation of limb

A cohort post limb conserving surgery

Patients whose surgical management involved conservation of their injured limb

Eligibility Criteria

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

Patients will be recruited by phone from databases issued by: * A surgical clinic, The Clinique Lambert (Pétion-Ville, Haiti), * Two non-governmental organizations * Handicap International (HI) * Bangladesh Rural Advancement Committee (BRAC), * A local organization l'Union des Jeunes Victimes du Séisme (UJVS)

You may qualify if:

  • Patients, with limb injuries due to the earthquake,
  • Who underwent limb surgery, which ended up in limb amputation or limb conservation.

You may not qualify if:

  • Limb injury not related to the earthquake
  • No surgery for the limb injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ALIMA

Port-au-Prince, Port-au-Prince, Haiti

Location

Related Links

MeSH Terms

Conditions

Wounds and InjuriesAmputation, Traumatic

Study Officials

  • Marie-Christine Delauche, MD

    Alliance for International Medical Action

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2012

First Posted

January 29, 2013

Study Start

January 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

January 29, 2013

Record last verified: 2013-01

Locations

HA(1)