Bone Physiology & Mechanics in Osteomyoplasty Amputation Rehabilitation
|ClinicalTrials.gov Identifier: NCT00271362|
Recruitment Status : Terminated (This project is no longer active with DVA.)
First Posted : December 30, 2005
Last Update Posted : April 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Amputation Fracture Inflammation Osteoporosis||Behavioral: Amputation rehabilitation exercise program Procedure: Osteomyoplasty vs. routine long posterior flap||Not Applicable|
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:
- Hypothesis 1: results in fewer detrimental effects on bone metabolism, structure, and mass.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||95 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bone Physiology & Mechanics in Osteomyoplasty Amputation Rehabilitation|
|Actual Study Start Date :||January 2006|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||December 2010|
Active Comparator: 1
comparing 2 surgical procedures
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.
- Bone Integrity [ Time Frame: 6 weeks - 6 months ]
- Inflammatory Response [ Time Frame: 6 weeks - 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00271362
|United States, Oklahoma|
|VA Medical Center, Oklahoma City|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator:||Daniel J. Brackett, MD||VA Medical Center, Oklahoma City|