Status:
TERMINATED
Bone Physiology & Mechanics in Osteomyoplasty Amputation Rehabilitation
Lead Sponsor:
VA Office of Research and Development
Conditions:
Amputation
Fracture
Eligibility:
All Genders
18+ years
Phase:
NA
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 tw...
Eligibility Criteria
Inclusion
- Adult lower limb PVD-related or traumatic amputees who are appropriate candidates for amputation rehabilitation exercise.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00271362
Start Date
January 1 2006
End Date
December 1 2010
Last Update
April 21 2017
Active Locations (1)
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1
VA Medical Center, Oklahoma City
Oklahoma City, Oklahoma, United States, 73104