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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00271362 |
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 |
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Amputation Fracture Inflammation Osteoporosis |
Behavioral: Amputation rehabilitation exercise program Procedure: Osteomyoplasty vs. routine long posterior flap |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Bone Physiology & Mechanics in Osteomyoplasty Amputation Rehabilitation |
Estimated Enrollment: | 95 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
comparing 2 surgical procedures
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Behavioral: Amputation rehabilitation exercise program
participants will be physically exercised with a full array of exercise methodologies.
Procedure: Osteomyoplasty vs. routine long posterior flap
participants enrolled randomly in one of two surgical procedures.
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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:
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 older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adult lower limb PVD-related or traumatic amputees who are appropriate candidates for amputation rehabilitation exercise.
Exclusion Criteria:
Contact: Janet Wells, BS RN | janet-wells@ouhsc.edu | |
Contact: Daniel J Brackett, MD | daniel-brackett@ouhsc.edu |
United States, Oklahoma | |
VA Medical Center, Oklahoma City | Recruiting |
Oklahoma City, Oklahoma, United States, 73104 | |
Contact: Debbie Simmons 405-270-1545 debbie.simmons2@va.gov | |
Contact: Philip C Comp, MD PhD (405) 271-6466 philip.comp@va.gov | |
Principal Investigator: Daniel J. Brackett, MD |
Principal Investigator: | Daniel J. Brackett, MD | VA Medical Center, Oklahoma City |
Responsible Party: | Department of Veterans Affairs ( Brackett, Daniel - Principal Investigator ) |
Study ID Numbers: | O3789I |
Study First Received: | December 28, 2005 |
Last Updated: | July 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00271362 |
Health Authority: | United States: Federal Government |
Exercise Physical function Prosthetic mobility Rehabilitation |
Musculoskeletal Diseases Fractures, Bone Osteoporosis |
Bone Diseases, Metabolic Bone Diseases Inflammation |
Pathologic Processes |