NCT00263497

Brief Summary

Most trauma survivors in low-income countries develop post-injury chronic pain syndromes. Normally traumatic amputees have to wait 4-6 months for definitive prosthesis fitting. The actual study aims at reducing post-injury chronic pain and improving function by immediate temporary prosthesis fitting after surgery.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

December 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2005

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
14 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

14 years

First QC Date

December 7, 2005

Last Update Submit

March 6, 2020

Conditions

Transtibial Amputation

Keywords

Postinjury chronic painTranstibial amputationPhysical rehabilitationImmediate temporary prosthesis

Outcome Measures

Primary Outcomes (4)

  • Pain: Patient-rated

    1, 3, and 6 months postinjury

  • Pain: clinical exam rated

    1, 3, and 6 months post-injury

  • Function: patient-rated

    1, 3, and 6 months post-injury

  • Function: gait analysis

    1, 3, and 6 months post-injury

Secondary Outcomes (1)

  • Qualitative longitudinal study of subsets

    1, 3, and 6 months post-injury

Interventions

Temporary tuber-ischii bearing prosthesisDEVICE

Tuber ischii-bearing holster is connected by hinged metal bars to foot device to enable immediate postoperative mobilization of transtibial amputees. No other medical interventions or pharmaceutical treatment.

Eligibility Criteria

Age15 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Traumatic transtibial amputation

You may not qualify if:

  • Double amputation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trauma Care Foundation Cambodia

Battambang, 9500, Cambodia

Location

Study Officials

  • Bjoern Karlsson, Rehab Ing

    TMC, University Hospital Northern Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2005

First Posted

December 8, 2005

Study Start

March 1, 2006

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations

CA(1)