Vertebroplasty and Kyphoplasty in Osteoporotic Vertebral Body Fractures.

NCT03682328 | Unknown

• 1 other identifier: Vertebroplasty and kyphoplasty
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Osteoporotic Fracture of Vertebra

Keywords

Vertebroplasty; Kyphoplasty; Osteoporosis; Vertebral fractures

Outcome Measures

Primary Outcomes (1)

• back pain

  Measuring and comparing the post-operative back pain via Visual analogue scales system

  up to 6 months

Secondary Outcomes (1)

• kyphotic deformity

  up to 6 months

Study Arms (2)

vertebroplasty

ACTIVE COMPARATOR

Patients will be managed by equipment of vertebroplasty (Osteofix from Tsunami Medical Made in Italy which is composed of a packet of PMMA and ampule of MMA).

Procedure: vertebroplasty

kyphoplasty

ACTIVE COMPARATOR

Patients will be managed by equipment of kyphoplasty (Osteofix from Tsunami Medical Made in Italy which is composed of a packet of PMMA and ampule of MMA).

Procedure: kyphoplaty

Interventions

vertebroplasty PROCEDURE

Cement augmentation of the vertebral body

vertebroplasty

kyphoplaty PROCEDURE

Cement augmentation of the vertebral body

kyphoplasty

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: \> 60 years.
• Sex: both males and females.
• Compressive and burst vertebral body fractures without any neurological deficit.
• Failure of medical treatment for at least 3-4 weeks

You may not qualify if:

• Unmanageable bleeding disorder.
• Improvement of the symptoms of the patient with conservative management.
• Asymptomatic vertebral body fracture or presence of neurological deficit.
• Local or generalized infection.
• Known allergy to bone cement.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Lieberman IH, Togawa D, Kayanja MM. Vertebroplasty and kyphoplasty: filler materials. Spine J. 2005 Nov-Dec;5(6 Suppl):305S-316S. doi: 10.1016/j.spinee.2005.02.020.

  PMID: 16291128 BACKGROUND

• Phillips FM. Minimally invasive treatments of osteoporotic vertebral compression fractures. Spine (Phila Pa 1976). 2003 Aug 1;28(15 Suppl):S45-53. doi: 10.1097/01.BRS.0000076898.37566.32.

  PMID: 12897474 BACKGROUND

MeSH Terms

Conditions

Osteoporosis; Spinal Fractures

Interventions

Vertebroplasty

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Cementoplasty; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Ahmed Abdalla, MD

  Assiut University

  STUDY CHAIR

Central Study Contacts

Mahmoud Gamal, M.Sc

CONTACT

+201000630887; mahmoud_gamal20102000@yahoo.com

Mohammad Taghyan, MD

CONTACT

01006876892; mtoghyan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 24, 2018
• Study Start: October 1, 2018
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: September 24, 2018

Record last verified: 2018-09