NCT00271362

Terminated

Bone Physiology & Mechanics in Osteomyoplasty Amputation Reh...

VA Office of Research and Development Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

O3789-I

Study Type

interventional

Estimated enrollment

95

Locations

1 country

Sites

1

Timeline

Study Start

January 2006

Actual (reported)

Primary Completion

June 2010

Actual (reported)

Study Completion

December 2010

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Estimated enrollment: 95 participants
Study completion date: December 2010
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
December 28, 2005
Actual (reported)
First Posted
December 30, 2005
Actual (reported)
Study Start
January 2006
Actual (reported)
Primary Completion
June 2010
Actual (reported)
Study Completion
December 2010
Actual (reported)

Last Updated: April 21, 2017
Status Verified: April 2017
Last Update Submitted: April 19, 2017

Conditions

Amputation Fracture Inflammation Osteoporosis

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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:

Sponsors & Collaborators

VA Office of Research and Development
US federal agencylead

Study Sites (1)

VA Medical Center, Oklahoma City

Oklahoma City, Oklahoma, 73104, United States

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 2006

Actual (reported)

Primary Completion

June 2010

Actual (reported)

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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.

Study Completion

December 2010

Actual (reported)

Last Updated

April 21, 2017

Record last verified: 2017-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00271362
Data provider: ClinicalTrials.gov
Source updated: 2017-04-21
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:31:28 UTC

Locations

US(1)

Study Stopped

Bone Physiology & Mechanics in Osteomyoplasty Amputation Rehabilitation

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations