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Spinal Fractures clinical trials

View clinical trials related to Spinal Fractures.

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NCT ID: NCT00749242 Completed - SPINAL Fracture Clinical Trials

Comparative Study of Balloon Kyphoplasty and Conservative Treatment

TRAUMAA1-2-3
Start date: December 2007
Phase: Phase 4
Study type: Interventional

This study will compare two treatments in acute stable traumatic vertebral fractures (types A1, A2 and A3.1 in MAGERL Classification). The two treatments are the followings: 1. Conservative Orthopedic Management consisting of brace and pain medication. 2. Percutaneous Balloon Kyphoplasty, a variant of Vertebroplasty, in which a balloon is first placed into the fractured vertebra and inflated with fluid in order to create a cavity. This may restore part of the vertebral height loss due to the fracture and facilitate the injection of the cement with low pressure. The primary outcome will be the variation in the angle of Regional Vertebral Kyphosis (or, in the case of asymmetrical fractures, the angle of lateral vertebral inclination) between inclusion and one year follow-up. It will indicate if Balloon Kyphoplasty is able to restore vertebral height of the fractured vertebra better than Conservative Orthopedic Management.

NCT ID: NCT00749229 Terminated - Clinical trials for Located Between T11 and L5

Feasibility Study of Balloon Kyphoplasty in Traumatic Vertebral Fractures Needing Surgical Fixation

TRAUMAA3B1C1
Start date: December 2007
Phase: Phase 4
Study type: Interventional

Some unstable traumatic vertebral fractures (types A3.2, A3.3, B1 et C1 according to MAGERL classification) may undergo unpredictable secondary displacement. Such fractures require a two session surgery with a first operation carried out immediately to achieve posterior fixation and a second surgery which is performed some days later to stabilize the anterior spine and restore stress resistance. Goal of the present study is to show that percutaneous Balloon Kyphoplasty is able to restore anterior spine strength and replace second session surgery.

NCT ID: NCT00749086 Completed - Clinical trials for Osteoporotic Vertebral Fracture

Comparison of Balloon Kyphoplasty and Vertebroplasty in Subacute Osteoporotic Vertebral Fractures

OSTEO+6
Start date: December 2007
Phase: Phase 4
Study type: Interventional

This study aims to compare two treatments in subacute (more than 6 week duration) non-traumatic (usually osteoporotic) vertebral fractures. The two treatments are the following: 1. Vertebroplasty consisting in the percutaneous injection into the fractured vertebra of polymethylmetacrylate cement (the cement used to fix prosthesis in joint replacement) through a posterior route through the vertebral pedicles under radiological guidance. 2. Balloon Kyphoplasty which consists of placing through a percutaneous posterior approach under radiological guidance, into the fractured vertebra a balloon which is inflated with fluid and creates a cavity. This may restore part of the vertebral height loss due to the fracture. In addition, after balloon deflation, polymethylmetacrylate cement is injected with low pressure into the created cavity to fix fracture reduction. The study will indicate if balloon kyphoplasty is able to restore vertebral height of the fractured vertebra better than vertebroplasty.

NCT ID: NCT00749060 Completed - Clinical trials for Osteoporotic Vertebral Fracture

Comparison of Balloon Kyphoplasty, Vertebroplasty and Conservative Management in Acute Osteoporotic Vertebral Fractures

OSTEO-6
Start date: December 2007
Phase: N/A
Study type: Interventional

This study aims to compare three treatments in recent (less than 6 week duration) non-traumatic ( usually osteoporotic) vertebral fractures.

NCT ID: NCT00748631 Terminated - Multiple Myeloma Clinical Trials

Treatment of Malignant Vertebral Fractures With Percutaneous Balloon Kyphoplasty.

KYPHOK
Start date: October 2007
Phase: N/A
Study type: Interventional

Balloon Kyphoplasty is an alternative to vertebroplasty in the treatment of painful malignant vertebral fractures. This is a mini-invasive percutaneous treatment, aiming to stabilize the vertebral fracture, decrease of pain. This technique also improves patient function. Namely, bedridden patients are often able to resume walking in the days following vertebral cement injection. Advantage of Balloon Kyphoplasty as compared to vertebroplasty is the ability to inject the cement into the diseased vertebral body which shows cortical destruction with lower pressure, thereby possibly reducing cement leakage and related complications. This is a multicentric, observational prospective study. Patients are evaluated before and after the procedure. Sixty women or men older than 18 years, with 1 to 3 painful vertebral fracture(s) of malignant origin (due to multiple myeloma or osteolytic vertebral metastasis) will be enrolled. Each patient will be followed during 1 year after the procedure with 7 visits at D-8, D-1, D1, D15, D90, D180, and D360 or until the death of the patient. The main evaluation outcome is patient self-global satisfaction regarding the procedure on a semi-quantitative satisfaction scale, 15 days after the Balloon Kyphoplasty.

NCT ID: NCT00713258 Terminated - Back Pain Clinical Trials

The Effect of PTH(1-84) or Alendronate on Reduction of Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) (FP-005-IM)

Start date: April 2008
Phase: Phase 4
Study type: Interventional

The primary objective of this trial is to show that PTH(1-84) is superior to alendronate in reducing back pain intensity over a 24-week treatment period in postmenopausal women with an osteoporosis related vertebral fracture(s). Secondly the objectives are to investigate any differences in patient reported outcomes between the two treatment arms over a 24-week treatment period in postmenopausal women with an osteoporosis related vertebral fracture(s).

NCT ID: NCT00679978 Completed - Rheumatic Diseases Clinical Trials

Vertebral Fracture and Osteonecrosis Associated With High-dose Glucocorticoid

Start date: January 2001
Phase: Phase 4
Study type: Observational

Osteoporotic vertebral fracture (VF) and osteonecrosis of the femoral head (OFH) are major concerns in patients with systemic rheumatic diseases treated with high-dose glucocorticoids (GCs). The investigators examined and compared the incidence and risk factors of VF with those of OFH in patients who had recently received high-dose GC therapy to clarify the relationship between these two complications.

NCT ID: NCT00638768 Completed - Osteoporosis Clinical Trials

Effectiveness of Physiotherapy for Osteoporotic Spinal Fracture

Start date: February 2006
Phase: Phase 2
Study type: Interventional

The aim of this pilot study was to determine the effect of physiotherapy on impairments and health-related quality of life in people with a painful osteoporotic spinal fracture. It is hypothesised that physiotherapy will reduce impairments and improve quality of life in this patient group.

NCT ID: NCT00635297 Suspended - Osteoporosis Clinical Trials

Percutaneous Vertebroplasty: Prophylactic Treatment of Adjacent Vertebra

Start date: April 2008
Phase: N/A
Study type: Interventional

Percutaneous vertebroplasty is a treatment for painful osteoporotic compression fractures. Multiple reports have shown as high as 20 % refracturerates in vertebrae adjacent to those that have been treated with percutaneous vertebroplasty. The purpose of the study is to determine if prophylactic vertebroplasty of unfractured vertebrae adjacent to the treated fractured vertebrae can reduce the rates of refracture in adjacent vertebrae.

NCT ID: NCT00616694 Completed - Osteoporosis Clinical Trials

Impact of Vertebral Fracture Knowledge on Persistence in Subjects Taking Glucocorticoid Therapy

ACTIVATE
Start date: July 2002
Phase: Phase 4
Study type: Interventional

To evaluate the effect of subject knowledge of their disease status on persistence in subjects receiving Actonel 5 mg daily over a 12-month period for the prevention and treatment of GIO.