Bone Physiology & Mechanics in Osteomyoplasty Amputation Rehabilitation

• ClinicalTrials.gov Identifier: NCT00271362
• Recruitment Status: Terminated
• First Posted: December 30, 2005
• Last Update Posted: April 21, 2017
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Amputation; Fracture; Inflammation; Osteoporosis	Behavioral: Amputation rehabilitation exercise program; Procedure: Osteomyoplasty vs. routine long posterior flap	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 95 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Bone Integrity [ Time Frame: 6 weeks - 6 months ]

Secondary Outcome Measures :

1. Inflammatory Response [ Time Frame: 6 weeks - 6 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Oklahoma

VA Medical Center, Oklahoma City

Oklahoma City, Oklahoma, United States, 73104

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: Daniel J. Brackett, MD; VA Medical Center, Oklahoma City

More Information

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00271362
• Other Study ID Numbers: O3789-I
• First Posted: December 30, 2005
• Last Update Posted: April 21, 2017
• Last Verified: April 2017

Keywords provided by VA Office of Research and Development:

Exercise; Physical function; Prosthetic mobility; Rehabilitation

Additional relevant MeSH terms:

Osteoporosis; Inflammation; Pathologic Processes; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases