Vertebral Compression FracturePhase 4NCT01383616

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

A Phase 4 study testing Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA) in people with Vertebral Compression Fracture, run by Hospital for Special Surgery, New York at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 to 100 years
Conditions the study is for: Vertebral Compression Fracture
What is being tested?: Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 1 siteUnited States
Study dates: Jul 2006to Dec 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Hospital for Special Surgery
New York, New York, 10021

Other trials in United States

About this study

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.

Conditions: Vertebral Compression Fracture
Being tested: Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA)
Keywords: osteoporosis, vertebral compression fractures
Medical subject headings: Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01383616
Study group	Role	What they receive
Unipedicular kyphoplasty	Active comparator	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. Receives: Device: Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA)
Bipedicular Kyphoplasty group	Active comparator	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. Receives: Device: Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA)

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparison of 3 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups
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.
Measured: Preoperative questionnaire within 3 weeks before surgery and postoperative questionnaires at 3 months after surgery
Change in RDQ in the Bipedicular Group From 3 to 12 Months
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.
Measured: 3-12 months post operation

Secondary outcomes (8)

Anterior Vertebral Body Height Restoration Following Surgery With Kyphoplasty
Preoperative and postoperative thoracolumbar radiographs were used to calculate the percent changes of the anterior vertebral body heights.
Measured: Preoperative assessment within 3 weeks before surgery and postoperative day 1
Measurement of Change in Kyphotic (Cobb) Angle Following Kyphoplasty
Preoperative and postoperative thoracolumbar radiographs used to calculate the change in kyphotic (Cobb) angle of the spine following surgery
Measured: Preoperative assessment within 3 weeks before surgery and postoperative day 1
Comparison of 3 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups
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.
Measured: 3 months post-op
Comparison of 3 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups
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
Measured: 3 months post-op
Comparison of 12 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups
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
Measured: 12 months post-op
Comparison of 12 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups
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.
Measured: 12 months post-op
Comparison of 12 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups
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
Measured: 12 months post-op
Middle Vertebral Body Height Restoration Following Surgery With Kyphoplasty
Preoperative and postoperative thoracolumbar radiographs were used to calculate the percent changes of the middle vertebral body heights.
Measured: Preoperative assessment within 3 weeks before surgery and postoperative day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2006Dec 2012

First posted28 Jun 2011 (estimated)
Study startJul 2006
Primary completionDec 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Vertebral Compression FractureStudies of the same condition, open and under way.
More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01383616
Sponsor's protocol ID: 26033
Status last verified: Jun 2017
First submitted: 13 Jun 2011
Last updated: 2 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingPhase 2
Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions
Spinal Metastases
RecruitingObservational study
Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures
Vertebral Compression Fractures, Pathological Fracture
Active, not recruitingPhase 2
Cement Augmentation in Preventing Vertebral Body Compression Fracture Following Spine Stereotactic Radiosurgery in Patients With Solid Tumors and Spinal Metastases
Metastatic Malignant Neoplasm in the Spine, Metastatic Malignant Solid Neoplasm
Active, not recruiting
Sickle Cell Disease (SCD) Bone Pain Study
Sickle Cell Disease, Sickle Cell Anemia

All Vertebral Compression Fracture trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures
ClinicalTrials.gov ID: NCT01383616
Acronym / sponsor ID: 26033
Conditions: Vertebral Compression Fracture
Keywords: osteoporosis, vertebral compression fractures
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: Hospital for Special Surgery, New YorkUniversity, hospital or other
Study start: Jul 2006
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 28 Jun 2011 (estimated)
Results: Posted 2 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Unipedicular kyphoplasty	Active comparator	Device: 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	Active comparator	Device: 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.

Who may qualify

Ages: 50 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	Bipedicular Kyphoplasty group, Unipedicular kyphoplasty

Primary outcome

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.
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.

8 secondary outcomes

Anterior Vertebral Body Height Restoration Following Surgery With Kyphoplasty
Time frame: Preoperative assessment within 3 weeks before surgery and postoperative day 1
Measurement of Change in Kyphotic (Cobb) Angle Following Kyphoplasty
Time frame: Preoperative assessment within 3 weeks before surgery and postoperative day 1
Comparison of 3 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups
Time frame: 3 months post-op
Comparison of 3 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups
Time frame: 3 months post-op
Comparison of 12 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups
Time frame: 12 months post-op
Comparison of 12 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups
Time frame: 12 months post-op
Comparison of 12 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups
Time frame: 12 months post-op
Middle Vertebral Body Height Restoration Following Surgery With Kyphoplasty
Time frame: Preoperative assessment within 3 weeks before surgery and postoperative day 1

Results and safety

Results posted to the registry on 2 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Unipedicular Kyphoplasty	40	23
Bipedicular Kyphoplasty Group	44	21

Primary outcome: 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. Mean (Standard Deviation). Unit: units on a scale

Measure	Unipedicular Kyphoplasty n = 18	Bipedicular Kyphoplasty Group n = 18
Value	15 (4)	14 (5)

Unipedicular Kyphoplasty vs Bipedicular Kyphoplasty Group: p = 0.85, t-test, 2 sided

Population analysed: From the period of intervention to 3 month follow-up, 5 patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months. 3 patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months.

Primary outcome: Change in RDQ in the Bipedicular Group From 3 to 12 Months

Time frame: 3-12 months post operation. Mean (Standard Deviation). Unit: units on a scale

Measure	Bipedicular Kyphoplasty Group n = 15
Value	4.7 (1.8)

Bipedicular Kyphoplasty Group: p = 0.008, t-test, 2 sided

Population analysed: From the period of intervention to 12 month follow-up, 6 total patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 15 patients from this arm at 12 months.

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Unipedicular Kyphoplasty	0 of 40 (0%)	0 of 40 (0%)	Not reported
Bipedicular Kyphoplasty Group	0 of 44 (0%)	0 of 44 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Vertebral Compression Fracture

RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingPhase 2
Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions
Spinal Metastases
RecruitingObservational study
Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures
Vertebral Compression Fractures, Pathological Fracture
Active, not recruitingPhase 2
Cement Augmentation in Preventing Vertebral Body Compression Fracture Following Spine Stereotactic Radiosurgery in Patients With Solid Tumors and Spinal Metastases
Metastatic Malignant Neoplasm in the Spine, Metastatic Malignant Solid Neoplasm
Active, not recruiting
Sickle Cell Disease (SCD) Bone Pain Study
Sickle Cell Disease, Sickle Cell Anemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tzipora Kuba, PhD study director

Hospital for Special Surgery, New York

Joseph M Lane, MD principal investigator

Hospital for Special Surgery, New York

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01383616.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.