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

• ClinicalTrials.gov Identifier: NCT01383616
• Recruitment Status: Completed
• First Posted: June 28, 2011
• Results First Posted: July 2, 2017
• Last Update Posted: July 2, 2017
• Sponsor: Hospital for Special Surgery, New York
• Information provided by (Responsible Party): Hospital for Special Surgery, New York

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Vertebral Compression Fracture	Device: Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA)	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures
• Study Start Date: July 2006
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: December 2012

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Unipedicular kyphoplasty; 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.	Device: Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA); A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.
Active Comparator: Bipedicular Kyphoplasty group; 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.	Device: Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA); A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.

Outcome Measures

Primary Outcome Measures :

1. Comparison of 3 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups [ Time Frame: 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.
2. Change in RDQ in the Bipedicular Group From 3 to 12 Months [ Time Frame: 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 :

1. Anterior Vertebral Body Height Restoration Following Surgery With Kyphoplasty [ Time Frame: 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.
2. Measurement of Change in Kyphotic (Cobb) Angle Following Kyphoplasty [ Time Frame: 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
3. Comparison of 3 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups [ Time Frame: 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.
4. Comparison of 3 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups [ Time Frame: 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
5. Comparison of 12 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups [ Time Frame: 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
6. Comparison of 12 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups [ Time Frame: 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.
7. Comparison of 12 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups [ Time Frame: 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
8. Middle Vertebral Body Height Restoration Following Surgery With Kyphoplasty [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, New York

Hospital for Special Surgery

New York, New York, United States, 10021

Sponsors and Collaborators

Hospital for Special Surgery, New York

Investigators

• Study Director: Tzipora Kuba, PhD; Hospital for Special Surgery, New York
• Principal Investigator: Joseph M Lane, MD; Hospital for Special Surgery, New York

More Information

• Responsible Party: Hospital for Special Surgery, New York
• ClinicalTrials.gov Identifier: NCT01383616
• Other Study ID Numbers: 26033
• First Posted: June 28, 2011
• Results First Posted: July 2, 2017
• Last Update Posted: July 2, 2017
• Last Verified: June 2017

Keywords provided by Hospital for Special Surgery, New York:

osteoporosis; vertebral compression fractures

Additional relevant MeSH terms:

Fractures, Bone; Spinal Fractures; Fractures, Compression; Wounds and Injuries; Spinal Injuries; Back Injuries