NCT03682328

Vertebroplasty and Kyphoplasty in Osteoporotic Vertebral Body Fractures.

Status unknown NA Last updated 24 September 2018

What this trial tests

NA trial testing vertebroplasty in Osteoporotic Fracture of Vertebra in 23 participants. Status unknown.

Timeline

1 October 2018

Primary endpoint
1 August 2020

1 September 2020

Quick facts

Lead sponsor	Assiut University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	23
Start date	1 October 2018
Primary completion	1 August 2020
Estimated completion	1 September 2020

Drugs / interventions tested

• vertebroplasty
• kyphoplaty

Conditions studied

• Osteoporotic Fracture of Vertebra — all drugs for Osteoporotic Fracture of Vertebra →

Sponsor

Assiut University

Who can join

60 and older, any sex, with Osteoporotic Fracture of Vertebra. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Vertebral body fractures are a major health care problem in all countries with incidence 1.4%. They are a common cause of severe debilitating pain, with consequent deteriorated quality of life, physical function and psychosocial performance.

Surgery is indicated in patients with vertebral body fracture, and concurrent spinal instability or neurologic deficit. The cornerstone of management for vertebral body fractures without neurological impairment is medical therapy, which include analgesics, bed rest, orthoses and rehabilitation. In the majority of patients such treatment modalities are effective. However, conservative management measures are not indicated for every type of fracture. For example, in older patients with vertebral fractures and cardio-respiratory disease it is not possible to prescribe bedrest for long period. Moreover, sometimes anti-inflammatory drugs are poorly tolerated by older patients, and bed rest can lead to further demineralization of the vertebrae, predisposing to future fractures.

Percutaneous minimally invasive vertebral augmentation methods for cement application into the vertebral body are a useful tool for the management of symptomatic fractures without neurological impairment when conventional measures of treatment can not be adopted. Two different percutaneous minimally invasive vertebral augmentation methods for cement application into the vertebral body for the management of symptomatic vertebral body fractures without neurological impairment have been developed, namely vertebroplasty and kyphoplasty.

Kyphoplasty and vertebroplasty have gained wide acceptance worldwide to manage patients without neurological impairment suffering from unmanageable pain caused by vertebral body fractures. Both procedures depend on mechanical stabilization of the fracture produced by cement injection into the fractured vertebral body.

Cement augmentation of the vertebral body by vertebroplasty and kyphoplasty was originally introduced for osteoporotic compression fractures, but surgeons have now applied these techniques as a method of enhancing anterior column support while avoiding the morbidity and complications associated with anterior approaches.

The mainstay of the controversy between kyphoplasty and vertebroplasty are height restoration, whether or not this height restoration is clinically significant, and the risks related to height restoration.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.