NCT00271362

Brief Summary

The purpose of the study is to compare the effect of different lower limb amputation surgical procedures on leg bone integrity and rehabilitation outcome.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 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 28, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 30, 2005

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 21, 2017

Status Verified

April 1, 2017

Enrollment Period

4.4 years

First QC Date

December 28, 2005

Last Update Submit

April 19, 2017

Conditions

AmputationFractureInflammationOsteoporosis

Keywords

ExercisePhysical functionProsthetic mobilityRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Bone Integrity

    6 weeks - 6 months

Secondary Outcomes (1)

  • Inflammatory Response

    6 weeks - 6 months

Study Arms (1)

1

ACTIVE COMPARATOR

comparing 2 surgical procedures

Behavioral: Amputation rehabilitation exercise programProcedure: Osteomyoplasty vs. routine long posterior flap

Interventions

Amputation rehabilitation exercise programBEHAVIORAL

participants will be physically exercised with a full array of exercise methodologies.

1
Osteomyoplasty vs. routine long posterior flapPROCEDURE

participants enrolled randomly in one of two surgical procedures.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult lower limb PVD-related or traumatic amputees who are appropriate candidates for amputation rehabilitation exercise.

You may not qualify if:

  • Cognitive dysfunction (MiniMental scores \<23), advanced neuropathies, or neurological impairment (CVA, Parkinson's) with residual loss of function enough to preclude exercise;
  • Unresolved MI (high isoenzymes), angina, arrhythmia, 3rd degree AV block, fixed-rate pacer;
  • Recent embolus/thrombophlebitis, myocarditis, pericarditis, or cardiomyopathy;
  • Resting SBP \>200mmHg or DBP \>100mmHg;
  • Uncontrolled metabolic disease, liver or kidney failure, alcohol/drug addiction; acute infection;
  • Exercise-exacerbated neuromuscular/musculoskeletal disorders; irreducible hip/leg contractures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center, Oklahoma City

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Fractures, BoneInflammationOsteoporosisMotor Activity

Condition Hierarchy (Ancestors)

Wounds and InjuriesPathologic ProcessesPathological Conditions, Signs and SymptomsBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Study Officials

  • Daniel J. Brackett, MD

    VA Medical Center, Oklahoma City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2005

First Posted

December 30, 2005

Study Start

January 1, 2006

Primary Completion

June 1, 2010

Study Completion

December 1, 2010

Last Updated

April 21, 2017

Record last verified: 2017-04

Locations

US(1)