Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00271362
Status:
TERMINATED
Last Update Posted:
2017-04-21
First Post:
2005-12-28
Brief Title:
Bone Physiology Mechanics in Osteomyoplasty Amputation Rehabilitation
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Bone Physiology Mechanics in Osteomyoplasty Amputation Rehabilitation
Status:
TERMINATED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This project is no longer active with DVA
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None