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Bone Physiology & Mechanics in Osteomyoplasty Amputation Rehabilitation

This study has been terminated.
(This project is no longer active with DVA.)
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00271362
First received: December 28, 2005
Last updated: November 4, 2010
Last verified: November 2010
  Purpose

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
Amputation
Fracture
Inflammation
Osteoporosis
Behavioral: Amputation rehabilitation exercise program
Procedure: Osteomyoplasty vs. routine long posterior flap

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bone Physiology & Mechanics in Osteomyoplasty Amputation Rehabilitation

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Bone Integrity [ Time Frame: 6 weeks - 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammatory Response [ Time Frame: 6 weeks - 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 95
Study Start Date: January 2006
Estimated Study Completion Date: December 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271362

Locations
United States, Oklahoma
VA Medical Center, Oklahoma City
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
Investigators
Principal Investigator: Daniel J. Brackett, MD VA Medical Center, Oklahoma City
  More Information

No publications provided

Responsible Party: Brackett, Daniel - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00271362     History of Changes
Other Study ID Numbers: O3789I
Study First Received: December 28, 2005
Last Updated: November 4, 2010
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Exercise
Physical function
Prosthetic mobility
Rehabilitation

Additional relevant MeSH terms:
Inflammation
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014