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Fractures, Bone

Osteoporosis

Fractures, Compression

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Metabolic Diseases

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Vasodilator Agents

All Drugs and Chemicals

Polymethyl Methacrylate

This group of patients will be treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.

The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.

Balloon kyphoplasty

The study objective is to collect and report 12-month outcomes pertaining to activities of daily living, quality of life, and safety parameters in a Medicare population to be treated with balloon kyphoplasty in the treatment of painful, acute, vertebral body compression fractures (VCFs) associated with either osteoporosis or cancer. The primary objective is to show statistically significant improvement from baseline in the four co-primary endpoints (SF-36v2, PCS, EQ-5D, NRS back pain and ODI) at 3-months; study success will be declared if the primary objective is met. New radiographic fractures, non-surgical management received, VCF-related healthcare resource utilization, and vertebral body height restoration data will also be collected.

Evaluation of Outcomes for Quality of Life and Activities of Daily Living for BKP in the Treatment of VCFs

A Prospective and Multicenter Evaluation of Outcomes for Quality of Life and Activities of Daily Living for Balloon Kyphoplasty in the Treatment of Vertebral Compression Fractures

Back pain was measured using NRS. Patients rated their back pain on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."

ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).

Quality of life was assessed by Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) version 2.0. The SF-36 v2 physical component summary (PCS) score is between 0 and 100, with higher scores denoting better quality of life.

EQ-5D index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health.

For subjects with osteoporosis, the Barthel index was used for rating subject activities of daily living on a scale from 0 (maximum disability) to 20 (no disability).

For subjects with cancer, the Karnofsky performance scale was used for rating subject activities of daily living.The Karnofsky performance scale rates a subject on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease), and a score of 70 is a clinically meaningful threshold for self-care.

AHRP (Absolute height restored as percent) was the amount of height restored in the vertebral body expressed as a percent of estimated pre-fracture (EP) height. Measurements were assessed at anterior, medial, and posterior locations on the vertebral body.

The vertebral body kyphosis angle (VBA) was defined as the angle formed by lines drawn parallel to the caudal and cranial fractured vertebral body endplates.

The local Cobb angle (LCA) was defined as the angle formed by lines drawn parallel to the superior endplate of the vertebral body above and the inferior endplate of the vertebral body below.

A subsequent VCF was defined as any fracture at an index or non-index vertebral body occurring after the initial procedure as compared to baseline. The percentage of subjects having one or more subsequent VCFs is presented.

Neurological functions were assessed preoperatively and postoperatively. Each of the individual functions was comprised of a number of elements. Investigators evaluated whether observations in each function category was normal or abnormal, and documentation of abnormal findings were required for each element in that function. Success for each component was defined as maintenance or improvement from preoperative for all elements. Success for overall neurologic status was defined as successful in all components.

Medtronic Spinal and Biologics

This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.

Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.

Balloon Kyphoplasty

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

American Indian or Alaska Native

Asian

Black or African American

Native Hawaiian or other pacific islander

White

Other

Race/Ethnicity, Customized

Height

Weight

Middle

Posterior

A total of 490 treated levels in 344 subjects were included in vertebral body height restoration analysis.

Estimated pre-fracture vertebral body height

Clinical Department

Back pain at baseline

Back pain at 3 Months

Back pain change

The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.

Back Pain Change From Baseline at 3 Months

ODI score at baseline

ODI score at 3 months

ODI change

Back Function Change From Baseline by Oswestry Disability Index at 3 Months

SF-36 PCS at baseline

SF-36 PCS at 3 months

SF-36 PCS change

SF-36v2 Physical Component Summary Change From Baseline at 3 Months

EQ-5D index at baseline

EQ-5D index at 3 months

EQ-5D index score change

Change From Baseline in Quality of Life by the EQ-5D Index at 3 Months

Back pain at 7 days

Back pain at 30 days

Back pain at 6 months

Back pain at 9 months

Back pain at 12 months

Back Pain

ODI score at 30 days

ODI score at 6 months

ODI score at 12 months

Back Function (ODI)

SF-36 PCS at 30 days

SF-36 PCS at 6 months

SF-36 PCS at 12 months

Quality of Life by SF-36v2 PCS

EQ-5D index at 30 days

EQ-5D index at 6 months

EQ-5D index at 12 months

Quality of Life by EQ-5D Index Score

Baseline

30 days

3 months

6 months

12 months

Percentage of Subjects Having Daily Living Activities Limited Due to Back Pain in the Previous 2 Weeks

days of limited activities at baseline

days of bed rest at baseline

days of limited activities at 30 days

days of bed rest at 30 days

days of limited activities at 3 months

days of bed rest at 3 months

days of limited activities at 6 months

days of bed rest at 6 months

days of limited activities at 12 months

days of bed rest at 12 months

The Number of Days With Limited Activities and Bed Rest Due to Back Pain in the Previous 2 Weeks;

Able to walk at baseline

Walk with aid at baseline

Unable to walk at baseline

Able to walk at 7 days

Walk with aid at 7 days

Unable to walk at 7 days

Able to walk at 30 days

Walk with aid at 30 days

Unable to walk at 30 days

Able to walk at 3 months

Walk with aid at 3 months

Unable to walk at 3 months

Able to walk at 6 months

Walk with aid at 6 months

Unable to walk at 6 months

Able to walk at 9 months

Walk with aid at 9 months

Unable to walk at 9 months

Able to walk at 12 months

Walk with aid at 12months

Unable to walk at 12 months

This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.

Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices

Ambulatory Status

Barthel index score at baseline

Barthel index score at 30 days

Barthel index score at 3 months

Barthel index score at 6 months

Barthel index score at 12 months

Barthel Index (Only for Subjects With Osteoporosis)

Karnofsky performance scale at baseline

Karnofsky performance scale at 30 days

Karnofsky performance scale at 3 months

Karnofsky performance scale at 6 months

Karnofsky performance scale at 12 months

Karnofsky Performance Scale

Anterior height Loss from EP at baseline

Middle height loss from EP at baseline

Posterior height loss from EP at baseline

Anterior AHRP at pre-discharge

Middle AHRP at pre-discharge

Posterior AHRP at pre-discharge

Anterior AHRP at 3 months

Middle AHRP at 3 months

Posterior AHRP at 3 months

Anterior AHRP at 12 months

Middle AHRP at 12 months

Posterior AHRP at 12 months

A total of 490 treated levels in 344 subjects were included in vertebral body height restoration analysis. The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.

Vertebral Body Height Restoration (Absolute Height Restored as Percent, AHRP)

vertebral body angle at baseline

Vertebral body angle at pre-discharge

Angle change from baseline at pre-discharge

Vertebral body angle at 3 months

Angle change from baseline at 3 months

Vertebral body angle at 12 months

Angle change from baseline at 12 months

A total of 490 treated levels in 344 subjects were included in VBA analysis. The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.

Vertebral Body Angle

Local Cobb angle at baseline

Local Cobb angle at pre-discharge

Local Cobb angle at 3 months

Local Cobb angle at 12 months

A total of 490 treated levels in 344 subjects were included in LCA analysis. The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Outcomes for Quality of Life and Activities of Daily Living for BKP in the Treatment of VCFs	NCT01871519	Compression Fra... Osteoporosis Cancer	Balloon kyphopl...	65 Years -	Medtronic Spinal and Biologics
Treatment of Malignant Vertebral Fractures With Percutaneous Balloon Kyphoplasty.	NCT00748631	Vertebral Fract... Multiple Myelom... Osteolytic Meta...	balloon kyphopl...	18 Years -	Assistance Publique - Hôpitaux de Paris
To Compare Conservative Management Vs. Balloon Kyphoplasty in the Treatment of VCFs in Patients With Multiple Myeloma	NCT02732925	Multiple Myelom...	Arm 2 Balloon K... Conservative Ma...	18 Years - 80 Years	Royal National Orthopaedic Hospital NHS Trust
To Compare Conservative Management Vs. Balloon Kyphoplasty in the Treatment of VCFs in Patients With Multiple Myeloma	NCT02732925	Multiple Myelom...	Arm 2 Balloon K... Conservative Ma...	18 Years - 80 Years	Royal National Orthopaedic Hospital NHS Trust
FREE Study - Fracture Reduction Evaluation	NCT00211211	Osteopenia Osteoporosis Multiple Myelom... Bone Neoplasms	Balloon Kyphopl...	21 Years -	Medtronic Spinal and Biologics
To Compare Conservative Management Vs. Balloon Kyphoplasty in the Treatment of VCFs in Patients With Multiple Myeloma	NCT02732925	Multiple Myelom...	Arm 2 Balloon K... Conservative Ma...	18 Years - 80 Years	Royal National Orthopaedic Hospital NHS Trust

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