AmputationNCT00271362
Bone Physiology & Mechanics in Osteomyoplasty Amputation Rehabilitation
A study testing Amputation rehabilitation exercise program and Osteomyoplasty vs. routine long posterior flap in people with Amputation and Fracture, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Fracture, Inflammation
- What is being tested?
- Amputation rehabilitation exercise program and Osteomyoplasty vs. routine long posterior flap
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult lower limb PVD-related or traumatic amputees who are appropriate candidates for amputation rehabilitation exercise.
Who cannot join
- Cognitive dysfunction (MiniMental scores <23), advanced neuropathies, or neurological impairment (CVA, Parkinson's) with residual loss of function enough to preclude exercise;
- Unresolved MI (high isoenzymes), angina, arrhythmia, 3rd degree AV block, fixed-rate pacer;
- Recent embolus/thrombophlebitis, myocarditis, pericarditis, or cardiomyopathy;
- Resting SBP >200mmHg or DBP >100mmHg;
- Uncontrolled metabolic disease, liver or kidney failure, alcohol/drug addiction; acute infection;
- Exercise-exacerbated neuromuscular/musculoskeletal disorders; irreducible hip/leg contractures.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center, Oklahoma City
Oklahoma City, Oklahoma, 73104
About this study
The purpose of the study is to compare the effect of different lower limb amputation surgical procedures on leg bone integrity and rehabilitation outcome.
Read the 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:
- 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.
- Conditions
- Amputation, Fracture, Inflammation, Osteoporosis
- Being tested
- Amputation rehabilitation exercise program, Osteomyoplasty vs. routine long posterior flap
- Keywords
- Exercise, Physical function, Prosthetic mobility, Rehabilitation
- Medical subject headings
- Fractures, Bone, Inflammation, Osteoporosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amputation rehabilitation exercise programBehavioural
participants will be physically exercised with a full array of exercise methodologies.
Osteomyoplasty vs. routine long posterior flapProcedure or surgery
participants enrolled randomly in one of two surgical procedures.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | comparing 2 surgical procedures Receives: Behavioral: Amputation rehabilitation exercise program; Procedure: Osteomyoplasty vs. routine long posterior flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Integrity
Measured: 6 weeks - 6 months
Secondary outcomes (1)
Inflammatory Response
Measured: 6 weeks - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2005 (estimated)
- Study startJan 2006
- Primary completionJun 2010
- Study completionDec 2010
Why it stopped: This project is no longer active with DVA.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Daniel J. Brackett, MD, Principal investigator, VA Medical Center, Oklahoma City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271362
- Sponsor's protocol ID
- O3789-I
- Status last verified
- Apr 2017
- First submitted
- 28 Dec 2005
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Physiology & Mechanics in Osteomyoplasty Amputation Rehabilitation
- ClinicalTrials.gov ID
- NCT00271362
- Acronym / sponsor ID
- O3789-I
- Conditions
- Amputation, Fracture, Inflammation, Osteoporosis
- Keywords
- Exercise, Physical function, Prosthetic mobility, Rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This project is no longer active with DVA.
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jan 2006 (actual)
- Primary completion
- Jun 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 30 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Amputation rehabilitation exercise program, Procedure: Osteomyoplasty vs. routine long posterior flapcomparing 2 surgical procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult lower limb PVD-related or traumatic amputees who are appropriate candidates for amputation rehabilitation exercise.
Key exclusion criteria (6 listed)
- Cognitive dysfunction (MiniMental scores <23), advanced neuropathies, or neurological impairment (CVA, Parkinson's) with residual loss of function enough to preclude exercise;
- Unresolved MI (high isoenzymes), angina, arrhythmia, 3rd degree AV block, fixed-rate pacer;
- Recent embolus/thrombophlebitis, myocarditis, pericarditis, or cardiomyopathy;
- Resting SBP >200mmHg or DBP >100mmHg;
- Uncontrolled metabolic disease, liver or kidney failure, alcohol/drug addiction; acute infection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amputation rehabilitation exercise programparticipants will be physically exercised with a full array of exercise methodologies. | Behavioural | 1 |
| Osteomyoplasty vs. routine long posterior flapparticipants enrolled randomly in one of two surgical procedures. | Procedure or surgery | 1 |
Primary outcome
Bone Integrity
Time frame: 6 weeks - 6 months
1 secondary outcome
Inflammatory Response
Time frame: 6 weeks - 6 months
Results and safety
The study was stopped early (reason given: This project is no longer active with DVA.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel J. Brackett, MD principal investigator
VA Medical Center, Oklahoma City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amputation rehabilitation exercise program and Osteomyoplasty vs. routine long posterior flap in people with Amputation and Fracture, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: This project is no longer active with DVA.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Integrity (time frame: 6 weeks - 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2017.