Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures

Phase 4

Completed

Conditions: Vertebral Compression Fracture

Interventions: Device: Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA)

Registration Number: NCT01383616

Lead Sponsor: Hospital for Special Surgery, New York

Brief Summary: Balloon kyphoplasty for the treatment of patients with osteoporotic vertebral compression fractures has been shown to be successful in providing acute pain relief, enabling improved function, and restoring of vertebral body height. However, limited prospective data exists in the investigation of unipedicular balloon kyphoplasty as a sufficient alternative to bipedicular balloon kyphoplasty. The purpose of this prospective randomized study was to compare the clinical and radiographic outcomes of unipedicular and bipedicular balloon kyphoplasty.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 84

Inclusion Criteria

Males or females older than 50 years of age with acute vertebral compression fractures causing significant pain and functional limitations in their daily activities.

Exclusion Criteria

primary tumors of bone or evidence of metastasis at the index vertebrae
pre-existing chronic pain or functional disability unrelated to a vertebral compression fracture which would confound the data analysis
fracture secondary to a traumatic event
inability to fully visualize both pedicles of the fractured vertebrae on intraoperative fluoroscopy

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unipedicular kyphoplasty	Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA)	Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm only vertebral body pedicle was entered to deliver bone cement.
Bipedicular Kyphoplasty group	Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA)	Balloon kyphoplasty achieves reduction of the vertebral compression fracture using a balloon tamp inserted into the vertebral body by a transpedicular approach, followed by fixation of the fracture fragments with polymethylmethacrylate (PMMA) bone cement. In this arm two pedicles were entered to deliver bone cement.

Primary Outcome Measures

Name	Time	Method
Comparison of 3 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups	Preoperative questionnaire within 3 weeks before surgery and postoperative questionnaires at 3 months after surgery	The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. The self-completed questionnaire contains ten topics. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Change in RDQ in the Bipedicular Group From 3 to 12 Months	3-12 months post operation	The Roland Morris Disability Questionnaire is a widely used health status measure for low back pain. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. A score of 0 indicates no low back pain, while a score of 24 indicates significant low back pain.

Secondary Outcome Measures

Name	Time	Method
Anterior Vertebral Body Height Restoration Following Surgery With Kyphoplasty	Preoperative assessment within 3 weeks before surgery and postoperative day 1	Preoperative and postoperative thoracolumbar radiographs were used to calculate the percent changes of the anterior vertebral body heights.
Comparison of 3 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups	3 months post-op	The Roland Morris Disability Questionnaire is a widely used health status measure for low back pain. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. A score of 0 indicates no low back pain, while a score of 24 indicates significant low back pain.
Comparison of 3 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups	3 months post-op	A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.\[1\] It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. The scale is from 1-10 with 10 as the highest level of pain, and 0 being no pain
Comparison of 12 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups	12 months post-op	The Roland Morris Disability Questionnaire is a widely used health status measure for low back pain. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. A score of 0 indicates no back pain, while a score of 24 indicates significant back pain.
Measurement of Change in Kyphotic (Cobb) Angle Following Kyphoplasty	Preoperative assessment within 3 weeks before surgery and postoperative day 1	Preoperative and postoperative thoracolumbar radiographs used to calculate the change in kyphotic (Cobb) angle of the spine following surgery
Comparison of 12 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups	12 months post-op	Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.\[2\] The scores for all questions answered are summed. Zero is equated with no disability and 50 is the maximum disability possible
Middle Vertebral Body Height Restoration Following Surgery With Kyphoplasty	Preoperative assessment within 3 weeks before surgery and postoperative day 1	Preoperative and postoperative thoracolumbar radiographs were used to calculate the percent changes of the middle vertebral body heights.
Comparison of 12 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups	12 months post-op	A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.\[1\] It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. The scale is from 1-10 with 10 as the highest level of pain, and 0 being no pain