Spine Fracture
Conditions
Keywords
fractures, compression, back pain, bone cements, kyphoplasty
Brief summary
Kyphoplasty(PKP) is performed under general anaesthesia in patients with osteoporotic vertebral compression fracture. The balloon is first placed into the fractured vertebra and inflated with contrast agent for height restoration. Then, the cement is injected into the cavity created by the balloon. As the diffusion of cement can be interfered by closely barriers formed by surrounding cancellous bones, refractures are often found in patients with conventional PKP. Furthermore, the loss of restored height of surgical vertebrae due to refracture in PKP. The investigators will applied a rotary cutter to destroy the structure of the cavity created by the balloon. Finally, the cement is injected, which may effectively interdigitates with the surrounding cancellous bone.
Interventions
DEVICEKyphoplasty with Rotary Cutter
The rotary cutter is applied before cement injection to destroy the structure around the cavity created by inflated balloon. Then, the rotary cutter will make the bone cement to support a wider range and to blend with the surrounding cancellous bones more densely.
DEVICEConventional Kyphoplasty
The cement is injected into the cavity created by PKP. The diffusion of cement can be interfered by closely barriers formed by surrounding cancellous bones.
Sponsors
Li Min
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is able to undergo the vertebroplasty or balloon kyphoplasty procedure 2. Patient has read and sign the informed consent 3. Male or female, 50 years or older 4. Compressive and burst vertebral body fractures without any neurological deficit. 5. Persistent pain despite medical treatment according to VAS ≥ 5 or a last resort to morphine treatment
Exclusion criteria
1. Neurological signs related to the vertebral fracture to treat 2. Unmanageable bleeding disorder 3. History of surgical or percutaneous spine treatment except simple discectomy at a single or multiple vertebral levels with no residual pain. 4. Known allergy to bone cement 5. Local or generalized infection 6. Improvement of the symptoms of the patient with conservative management
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Back pain: Visual analogue scales system | up to 2 years | Measuring and comparing the post-operative back pain via Visual analogue scales system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Refracture | up to 2 years | Number of new vertebral fractures documented radiologically |
| Kyphotic angle and global thoracic and lumbar angulations | up to 2 years | — |
| The patterns of cement opacification | during the procedure of PKP | The patterns of cement opacification were classified as solid patterns (cement forms a mass), trabecular patterns (cement spread along the fine bone trabeculae), and mixed patterns (cement forms a mass with spreading along the fine bone trabeculae) |
| Height of the treated vertebral body | Preoperative, up to 2 years | Follow-up of anterior, median and posterior height of the treated vertebral body, obtained by making an average of all measurements |
| Medico-economic follow-up | up to 2 years | Cost of intervention; Cost of prescribed medicines; Cost of follow-up visits; Cost of subsequent hospitalization; Cost of complications. |
Countries
China
Outcome results
None listed