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Bone Physiology & Mechanics in Osteomyoplasty Amputation Rehabilitation

Bone Physiology & Mechanics in Osteomyoplasty Amputation Rehabilitation

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00271362
Enrollment
95
Registered
2005-12-30
Start date
2006-01-31
Completion date
2010-12-31
Last updated
2017-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amputation, Fracture, Inflammation, Osteoporosis

Keywords

Exercise, Physical function, Prosthetic mobility, Rehabilitation

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.

Detailed description

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.

Interventions

BEHAVIORALAmputation rehabilitation exercise program

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

PROCEDUREOsteomyoplasty vs. routine long posterior flap

participants enrolled randomly in one of two surgical procedures.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Bone Integrity6 weeks - 6 months

Secondary

MeasureTime frame
Inflammatory Response6 weeks - 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026