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

Condition	Intervention
Amputation Osteoporosis Fracture Inflammation	Procedure: Osteomyoplasty vs. routine long posterior flap  Behavior: Amputation rehabilitation exercise program.

Further study details as provided by Department of Veterans Affairs:

Primary Outcomes: Bone and muscle integrity,inflammatory response,weight bearing,residual limb perfusion,activity level,prosthesis mobility and functional capacity,quality of life measured within 2 weeks after surgery, and at 6 weeks and 6 months post amputation surgery.
Secondary Outcomes: Intra-operative tourniquet time, medullary perfusion, and blood loss measured during surgery. Post-operative healing and infections during 6-month follow-up. Cost of treatment at 6 months.
Expected Total Enrollment:  95

Osteoporosis leading to increased risk of fracture, especially in the ipsilateral limb, is well documented in lower limb amputees. The purpose of this research is to examine the clinical utility of two amputation surgical procedures in: a) minimizing short and longer-term deleterious effects of amputation on bone integrity relative to the antecedents of osteoporotic change: reduced weight bearing capacity, inflammation, impaired muscle viability, and vascular compromise, and b) deriving benefit from prosthetic rehabilitation and exercise interventions.

In a randomized controlled clinical trial, we will test the hypotheses: In lower limb traumatic and dysvascular amputation, when compared to the transtibial long posterior flap amputation technique and the transfemoral Gottschalk method, the osteomyoplastic reconstruction technique developed by Ertl:

1. Hypothesis 1: results in fewer detrimental effects on bone metabolism, structure, and mass.
2. Hypothesis 2: leads to optimal rehabilitation and functional outcomes. Specifically, we will examine, in traumatic and dysvascular lower limb amputees randomly assigned to undergo either the long posterior flap amputation method or amputation with osteomyoplastic reconstruction in transtibial amputation and either the Gottschalk amputation method or amputation with osteomyoplastic reconstruction in transfemoral amputation, differences in the following parameters at baseline, 6 weeks (post-operative recuperation), and 6 months (termination of supervised rehabilitation and exercise intervention).

We will assess bone integrity in patients undergoing standard amputation versus osteomyoplastic reconstruction by measuring bone metabolism and bone mineral density and mineral content. Second, we will measure inflammatory response in patients undergoing standard amputation versus osteomyoplastic reconstruction by assessing weight bearing and impact, muscle integrity, and limb vascularity. Last, we will compare rehabilitation and functional outcome in patients undergoing standard amputation versus osteomyoplastic reconstruction by assessing prosthetic mobility, functional capacity, activity levels, and quality of life.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

6. Exercise-exacerbated neuromuscular/musculoskeletal disorders; irreducible hip/leg contractures.

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Please refer to this study by ClinicalTrials.gov identifier  NCT00271362

Janet Wells, BA, RN      405-270-0501  Ext. 3336    janet-wells@ouhsc.edu
David J Alexander, LVN      405-270-0501  Ext. 3336    david-alexander@ouhsc.edu

Oklahoma
      Oklahoma City VAMC, Oklahoma City,  Oklahoma,  73104,  United States

Study chairs or principal investigators

Jonelle E Wright, PhD MSN BSN,  Principal Investigator,  Oklahoma City VA Medical Center, Research & Development   

Study ID Numbers:  O3789I
Last Updated:  December 29, 2005
Record first received:  December 28, 2005
ClinicalTrials.gov Identifier:  NCT00271362
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10