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Randomized clinical trial (RCT) to compare treatment failure rates of surgical arthrodesis with MFB against cast treatment in patients suffering from early stage Charcot neuroarthropathy (CN) of the midfoot (Sella and Barrette stages 0, 1 or 2) within the first 2 years after initial treatment. Treatment failure is defined as the occurrence of one or more of the following: 1. Amputation, 2. Occurrence of ulcer or worsening of existing ulcer, 3. Surgical intervention for correction of deformity after initial treatment. The secondary aims are to compare foot function, radiologic outcome, quality of life, complications and foot temperature between the two groups.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Diabetes Mellitus 1 or 2
Surgery with Midfoot Fusion Bolt, Cast treatment
Dept. of Trauma and Reconstructive Surgery, University of Rostock
Not yet recruiting
AO Clinical Investigation and Documentation
Published on BioPortfolio: 2014-08-27T03:15:30-0400
People with diabetes often develop severe skin problems (ulcers) on their feet. Sometimes these are treated with surgery and other times by temporarily immobilizing the foot in a cast. T...
This study prospectively compares the performance of an above-elbow cast (long arm cast) and a below-elbow cast (short arm cast) to maintain reduction in conservatively managed distal radi...
The purpose of this study is to compare waterproof cast padding material to standard cotton/poly-cotton cast padding material to the presence or absence of cast sores of the heel.
To identify patient characteristics associated with non-response after spine fusion surgery for the treatment of degenerative disc disease (DDD).
The purpose of this protocol is to investigate the safety, tolerability and effectiveness of CAST as a treatment for diabetic neuropathy. The primary outcome measure will be Total Neuropa...
Although corrective cast (CC) has been back in use for the treatment of early onset scoliosis (EOS), no studies have reported how clinically meaningful CC was in comparison with brace-only treatment (...
The aim of this study was to determine long-term changes in pharmacological treatment of type 2 diabetes after primary Roux-en-Y gastric bypass (RYGB) surgery, in patients with and without pharmacolog...
The midfoot is instrumental to foot function; however, quantifying its roles in human movement have been difficult. A forceful dynamic activity like landing may help elucidate the midfoot's contributi...
Fiberglass casts are frequently valved to accommodate swelling following injury or surgery. The use of cast spacers has been recommended to bridge this gap between pressure reduction and cast strength...
It is very difficult to determine the fusion process of a spine using postoperative conventional radiological studies and determine whether additional fusion surgery is necessary. The aim of this retr...
Procedures, surgery, or other treatment without consent of person or persons receiving treatment.
The GENETIC RECOMBINATION of the parts of two or more GENES resulting in a gene with different or additional regulatory regions, or a new chimeric gene product. ONCOGENE FUSION includes an ONCOGENE as at least one of the fusion partners and such gene fusions are often detected in neoplastic cells and are transcribed into ONCOGENE FUSION PROTEINS. ARTIFICIAL GENE FUSION is carried out in vitro by RECOMBINANT DNA technology.
Urination of a large volume of urine with an increase in urinary frequency, commonly seen in diabetes (DIABETES MELLITUS; DIABETES INSIPIDUS).
A surgical specialty concerned with diagnosis and treatment of disorders of the heart, lungs, and esophagus. Two major types of thoracic surgery are classified as pulmonary and cardiovascular.
The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...