Bone Physiology & Mechanics in Osteomyoplasty Amputation Rehabilitation

NCT ID: NCT00271362

Last Updated: 2017-04-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2010-12-31

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.

Conditions

Amputation; Fracture; Inflammation; Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

comparing 2 surgical procedures

Group Type: ACTIVE_COMPARATOR

Amputation rehabilitation exercise program

Intervention Type: BEHAVIORAL

participants will be physically exercised with a full array of exercise methodologies.

Osteomyoplasty vs. routine long posterior flap

Intervention Type: PROCEDURE

participants enrolled randomly in one of two surgical procedures.

Interventions

Amputation rehabilitation exercise program

participants will be physically exercised with a full array of exercise methodologies.

Intervention Type: BEHAVIORAL

Osteomyoplasty vs. routine long posterior flap

participants enrolled randomly in one of two surgical procedures.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel J. Brackett, MD

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center, Oklahoma City

Locations

VA Medical Center, Oklahoma City

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

O3789-I

Identifier Type: -

Identifier Source: org_study_id