- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00271362
Bone Physiology & Mechanics in Osteomyoplasty Amputation Rehabilitation
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Förenta staterna, 73104
- VA Medical Center, Oklahoma City
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
Adult lower limb PVD-related or traumatic amputees who are appropriate candidates for amputation rehabilitation exercise.
Exclusion Criteria:
- 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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: 1
comparing 2 surgical procedures
|
participants will be physically exercised with a full array of exercise methodologies.
participants enrolled randomly in one of two surgical procedures.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Bone Integrity
Tidsram: 6 weeks - 6 months
|
6 weeks - 6 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Inflammatory Response
Tidsram: 6 weeks - 6 months
|
6 weeks - 6 months
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Daniel J. Brackett, MD, VA Medical Center, Oklahoma City
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- O3789-I
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