MDTSCORE: Medtronic SCORE Study - Study of Curette Use for Obtaining Restoration of Vertebral Body Anatomy in Balloon Kyphoplasty

• Sponsor: Medtronic Spine LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00810043
• Collaborator: (none)
• Enrollment: 120
• Locations: 13
• Arms: 2
• Duration (Months): 19.9
• Patients Per Site: 9.2
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The objective of this study is to measure the effect that the scraping and scoring of vertebral cancellous bone using the Kyphon® Curette has on vertebral body anatomy height restoration and angular deformity correction during a balloon kyphoplasty procedure.

Condition or Disease	Intervention/Treatment	Phase
Vertebral Body Compression Fractures (VCFs)	Device: Kyphon® Curette	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Study of Curette Use for Obtaining Restoration of Vertebral Body Anatomy in Balloon Kyphoplasty
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Curette-First All of patients in the study were treated with Balloon Kyphoplasty. During Balloon Kyphoplasty, two inflatable bone tamps (IBTs) are placed into the vertebral body bilaterally via a transpedicular or extrapedicular approach under fluoroscopic guidance. In this arm, curettage was performed prior to use of inflatable bone tamps.	Device: Kyphon® Curette; The Kyphon® Curette is intended to scrape and score bone in the spine. It may be used as an adjunctive device with Kyphon's family of standard access and fracture reduction instruments designed to treat compression fracture during balloon kyphoplasty procedures
Active Comparator: IBT-First All of patients in the study were treated with Balloon Kyphoplasty. During Balloon Kyphoplasty, two inflatable bone tamps (IBTs) are placed into the vertebral body bilaterally via a transpedicular or extrapedicular approach under fluoroscopic guidance. In this arm, inflatable bone tamps were used prior to curettage, then followed by a second inflation of the bone tamps.	Device: Kyphon® Curette; The Kyphon® Curette is intended to scrape and score bone in the spine. It may be used as an adjunctive device with Kyphon's family of standard access and fracture reduction instruments designed to treat compression fracture during balloon kyphoplasty procedures

Outcome Measures

Primary Outcome Measures

1. Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline) [Baseline and 48-hr post-procedure]

Secondary Outcome Measures

1. Index Vertebral Body Height Restored in Millimeters. [Baseline and 48 hours after procedure]

   Vertebral Body Height (VBH) was measured at anterior, midpoint, and posterior of index vertebral bodies. The data presented is the absolute height restored (AHR) between two time points.

2. Amount of Vertebral Body Height (VBH) Gained From IBTs Alone [Intra-operative measurement after postural reduction with Bolsters and intra-operative measurement after 1st round of IBT inflation.]

   Since all patients were treated in the prone position with chest and hip bolsters (this is referred to as postural reduction), vertebral body height (VBH) gained from IBTs alone was reported as the change of vertebral body height measured intra-operatively after postural reduction with bolsters to the 1st round of IBT inflation.

3. Amount of Vertebra Body Height (VBH) Gained by Postural Reduction [baseline and intra-operative]

4. Deformity Correction Assessed by Vertebral Body Kyphosis Angle (VBA) [Baseline and 48 hr post-procedure]

   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. Correction of angular deformity was expressed as a difference of absolute values between pre- and post-operative values. Any positive change indicated an improvement of angular correction and was defined as a change in angulation toward 0 degrees. Any negative change indicated a worsening of angular correction, and is defined as a change away from 0 degrees.

5. Deformity Correction Assessed by Local Cobb Angle (LCA) [baseline and 48 hr post-procedure]

   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. Correction of angular deformity was expressed as a difference of absolute values between pre- and post-operative values. Any positive change indicated an improvement of angular correction and was defined as a change in angulation toward 0 degrees. Any negative change indicated a worsening of angular correction, and is defined as a change away from 0 degrees.

6. Change in Back Pain. [Baseline and 48 hr post-procedure]

   Back pain was assessed by a numeric rating scale (Scale 1-10), with higher scores denoting worse pain.

7. Change in Ambulatory Status [Baseline and 48 hrs post-procedure]

   Ambulatory status was assessed by subjective patient questionnaire.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age >= 50 years

• One painful VCF meeting all of the following criteria:

• Fracture due to diagnosed or suspected underlying primary or secondary osteoporosis

• VCF is between T5 and L5

• VCF shows hyperintense signal on STIR or T2 weighted MRI

• VCF has at least 15% height loss as visualized on plain radiograph

• Identified painful VCF has at least superior and one normal vertebrae within 2 levels inferior.

• Either the immediate superior OR the immediate inferior vertebral body (but not both) may have a chronic fracture that does not need treatment.

• Patient states availability for all study visits

• Patient is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent

Exclusion Criteria:

• Patient is unable to undergo MRI

• Patient shows evidence of edema in vertebral bodies other than index level on MRI

• Patient is unable to stand for pre-operative and post-operative x-rays

• Patient body mass index (BMI) is greater than 35 kg/m2

• Patient is pregnant, or of child-bearing potential and not using contraception

• Vertebral body (VB) morphology or configuration is such that balloon kyphoplasty is not technically feasible or clinically appropriate for the index VCF

• Index fracture is result of high-energy trauma

• Suspected or proven cancer inside any VB

• Disabling back pain due to causes other than acute fracture

• Spine stabilization beyond balloon kyphoplasty required for index VCF

• Pre-existing conditions contrary to balloon kyphoplasty, such as:

• Irreversible coagulopathy or bleeding disorder. Note that patients on Coumadin or other anticoagulants may participate. Investigators should follow routine practices for perioperative discontinuation and re-initiation of anticoagulants.

• Allergy to any device materials (e.g., bone cement) for balloon kyphoplasty. Note that in patients with allergy to iodine-based contrast, other marketed approved non-iodine contrast solutions may be used.

• Any evidence of VB or systemic infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Foundation for Orthopaedic Research and Education	Temple Terrace	Florida	United States	33637
2	Atrium Medical Center	Middletown	Ohio	United States	45005
3	Aurora Medical Group, Memorial Hospital of Burlington	Burlington	Wisconsin	United States	53105
4	CHC - Les Cliniques Saint-Joseph	Liege		Belgium	4000
5	St. Augustinus ziekenhuis	Wilrijk		Belgium	2610
6	Charité Campus Virchow-Klinikum Berlin	Berlin		Germany	13353
7	Kliniken im Naturpark Altmühltal	Eichstätt		Germany	85072
8	Klinikum Kempten	Kempten		Germany	87439
9	Klinikum Leverkusen gGmbH	Leverkusen		Germany	51375
10	Paracelcus-Klinik München	München		Germany	81679
11	Kliniken Dr. Erler	Nurnberg		Germany	90429
12	Krankenhaus Barmherzige Bruder Regensburg	Regensburg		Germany	93049
13	Asklepios Orthopadische Klinik Lindenlohe	Schwandorf		Germany	92421

Sponsors and Collaborators

• Medtronic Spine LLC

Investigators

• Principal Investigator: George Fueredi, M.D., Aurora Heath Care, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Spine LLC
• ClinicalTrials.gov Identifier: NCT00810043
• Other Study ID Numbers: SP0801 - SCORE
• First Posted: Dec 17, 2008
• Last Update Posted: Dec 8, 2017
• Last Verified: Apr 1, 2014

• Additional relevant MeSH terms: Fractures, Compression

Study Results

Participant Flow

Arm/Group Title	Curette-First	IBT-First	Non-treated Patients
Arm/Group Description	Use of the curette prior to use of the inflatable bone tamps	Use of the inflatable bone tamps prior to using the curette	Patients who met the enrollment criteria at screening who had terminated prior to surgery or those who no longer met the inclusion criteria due to new fractures prior to surgery. These patients were never randomized to treatment because randomization was performed in the operating room.
Period Title: Overall Study
STARTED	57	55	8
COMPLETED	53	54	0
NOT COMPLETED	4	1	8

Baseline Characteristics

Arm/Group Title	Curette-First	IBT-First	Total
Arm/Group Description	Use of the curette prior to use of the inflatable bone tamps	Use of the inflatable bone tamps prior to using the curette	Total of all reporting groups
Overall Participants	57	55	112
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	73.6 (8.4)	76.0 (9.4)	74.8 (8.9)
Sex: Female, Male (Count of Participants)
Female	47 82.5%	41 74.5%	88 78.6%
Male	10 17.5%	14 25.5%	24 21.4%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	55 96.5%	55 100%	110 98.2%
Hispanic	1 1.8%	0 0%	1 0.9%
Middle Eastern	1 1.8%	0 0%	1 0.9%
Region of Enrollment (participants) [Number]
United States	13 22.8%	18 32.7%	31 27.7%
Belgium	18 31.6%	16 29.1%	34 30.4%
Germany	26 45.6%	21 38.2%	47 42%
Smoking history (Number) [Number]
Never Smoked	36 63.2%	36 65.5%	72 64.3%
Current Smoker	7 12.3%	5 9.1%	12 10.7%
Former Smoker	14 24.6%	14 25.5%	28 25%

Outcome Measures

1. Primary Outcome

Title	Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline)
Time Frame	Baseline and 48-hr post-procedure

Outcome Measure Data

Analysis Population Description

Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment

Arm/Group Title	Curette-First	IBT-First
Arm/Group Description	Use of curette prior to use of inflatable bone tamps	Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
Measure Participants	57	55
Anterior vertebral measurement (n=52, 50)	9.72 (12.85)	11.77 (13.23)
Mid-vertebral measurement (n=52, 50)	8.14 (9.96)	9.07 (10.31)
Posterior vertebral measurement (n=52, 50)	2.59 (5.15)	4.21 (6.49)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Curette-First, IBT-First
	Comments	Anterior vertebral body height restoration as a percent (Post-procedure change from baseline)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.430
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Curette-First, IBT-First
	Comments	Middle vertebral body height restoration as a percent (Post-procedure change from baseline)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.643
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Curette-First, IBT-First
	Comments	Posterior vertebral body height restoration as a percent (Post-procedure change from baseline)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.165
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Index Vertebral Body Height Restored in Millimeters.
Description	Vertebral Body Height (VBH) was measured at anterior, midpoint, and posterior of index vertebral bodies. The data presented is the absolute height restored (AHR) between two time points.
Time Frame	Baseline and 48 hours after procedure

Outcome Measure Data

Analysis Population Description

Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.

Arm/Group Title	Curette-First	IBT-First
Arm/Group Description	Use of the curette prior to use of the inflatable bone tamps	Use of the inflatable bone tamps prior to using the curette
Measure Participants	57	55
Anterior VBH at baseline (n=54, 53)	14.15 (5.25)	14.27 (5.02)
Anterior VBH at 48 hr post-procedure (n=56, 51)	16.65 (4.75)	17.32 (4.33)
Anterior change in VBH (n=53, 50)	2.28 (2.89)	2.78 (3.11)
Midpoint VBH at baseline (n=54, 53)	13.98 (4.12)	14.21 (4.07)
Midpoint VBH at 48 hr post-procedure (n=56, 51)	16.22 (4.01)	16.62 (3.39)
Midpoint change in VBH (n=53, 50)	1.98 (2.38)	2.25 (2.58)
Posterior VBH at baseline (n=54, 53)	22.79 (3.61)	22.94 (4.32)
Posterior VBH at 48 hr post-procedure (n=56, 51)	23.57 (3.99)	24.02 (3.59)
Posterior change in VBH (n=53, 50)	0.65 (1.29)	1.05 (1.65)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Curette-First, IBT-First
	Comments	Anterior VBH restored
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.402
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Curette-First, IBT-First
	Comments	Middle VBH restored
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.578
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Curette-First, IBT-First
	Comments	Posterior VBH restored
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.166
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Amount of Vertebral Body Height (VBH) Gained From IBTs Alone
Description	Since all patients were treated in the prone position with chest and hip bolsters (this is referred to as postural reduction), vertebral body height (VBH) gained from IBTs alone was reported as the change of vertebral body height measured intra-operatively after postural reduction with bolsters to the 1st round of IBT inflation.
Time Frame	Intra-operative measurement after postural reduction with Bolsters and intra-operative measurement after 1st round of IBT inflation.

Outcome Measure Data

Analysis Population Description

Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.

Arm/Group Title	IBT-First
Arm/Group Description	Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
Measure Participants	55
Anterior VBH at intra-op with Bolster (n=47)	17.03 (4.72)
Anterior VBH at Intra-op 1st IBT (n=49)	18.40 (4.67)
Anterior VBH change (n=47)	1.25 (1.94)
Middle VBH at intra-op with Bolster (n=47)	15.99 (3.60)
Middle VBH at Intra-op 1st IBT (n=49)	17.00 (3.32)
Middle VBH change (n=47)	0.94 (1.38)
Posterior VBH at intra-op with Bolster (n=47)	23.68 (3.85)
Posterior VBH at Intra-op 1st IBT (n=49)	24.05 (3.61)
Posterior VBH change (n=47)	0.37 (0.81)

4. Secondary Outcome

Title	Amount of Vertebra Body Height (VBH) Gained by Postural Reduction
Time Frame	baseline and intra-operative

Outcome Measure Data

Analysis Population Description

Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.

Arm/Group Title	Curette-First	IBT-First
Arm/Group Description	Use of curette prior to use of inflatable bone tamps	Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
Measure Participants	57	55
Anterior VBH at baseline (n=54, 53)	14.15 (5.25)	14.27 (5.02)
Anterior VBH at intra-op with Bolster (n=50, 47)	16.93 (4.99)	17.03 (4.72)
Anterior VBH gained (n=47, 46)	2.96 (3.55)	3.05 (3.21)
Middle VBH at baseline (n=54, 53)	13.98 (4.12)	14.21 (4.07)
Middle VBH at intra-op with Bolster (n=50, 47)	15.96 (4.36)	15.99 (3.60)
Middle VBH gained (n=47, 46)	1.88 (2.64)	2.14 (2.48)
Posterior VBH at baseline (n=54, 53)	22.79 (3.61)	22.94 (4.32)
Posterior VBH at Intra-op with Bolser (n=50, 47)	23.41 (4.02)	23.68 (3.85)
Posterior VBH gained (47, 46)	0.64 (1.69)	0.95 (1.53)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Curette-First, IBT-First
	Comments	Anterior VBH gained by postural reduction
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.900
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Curette-First, IBT-First
	Comments	Middle VBH gained by postural reduction
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.620
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Curette-First, IBT-First
	Comments	Posterior VBH gained by postural reduction
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.349
	Comments
	Method	t-test, 2 sided
	Comments

5. Secondary Outcome

Title	Deformity Correction Assessed by Vertebral Body Kyphosis Angle (VBA)
Description	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. Correction of angular deformity was expressed as a difference of absolute values between pre- and post-operative values. Any positive change indicated an improvement of angular correction and was defined as a change in angulation toward 0 degrees. Any negative change indicated a worsening of angular correction, and is defined as a change away from 0 degrees.
Time Frame	Baseline and 48 hr post-procedure

Outcome Measure Data

Analysis Population Description

Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.

Arm/Group Title	Curette-First	IBT-First
Arm/Group Description	Use of curette prior to use of inflatable bone tamps	Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
Measure Participants	57	55
VBA at baseline (n=54, 53)	-15.5 (7.17)	-15.1 (7.82)
VBA at 48 hr post-procedure (n=56, 51)	-12.4 (6.23)	-11.5 (6.84)
Angle change (n=53, 50)	2.88 (4.48)	3.00 (4.42)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Curette-First, IBT-First
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.889
	Comments
	Method	t-test, 2 sided
	Comments

6. Secondary Outcome

Title	Deformity Correction Assessed by Local Cobb Angle (LCA)
Description	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. Correction of angular deformity was expressed as a difference of absolute values between pre- and post-operative values. Any positive change indicated an improvement of angular correction and was defined as a change in angulation toward 0 degrees. Any negative change indicated a worsening of angular correction, and is defined as a change away from 0 degrees.
Time Frame	baseline and 48 hr post-procedure

Outcome Measure Data

Analysis Population Description

Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.

Arm/Group Title	Curette-First	IBT-First
Arm/Group Description	Use of curette prior to use of inflatable bone tamps	Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
Measure Participants	57	55
LCA at Baseline (n=53, 50)	-13.8 (15.09)	-11.5 (17.82)
LCA at 48 hr post-procedure (n=56, 49)	-10.70 (16.28)	-7.88 (16.29)
Angle change (n=52, 48)	1.36 (3.68)	1.87 (3.63)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Curette-First, IBT-First
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.486
	Comments
	Method	t-test, 2 sided
	Comments

7. Secondary Outcome

Title	Change in Back Pain.
Description	Back pain was assessed by a numeric rating scale (Scale 1-10), with higher scores denoting worse pain.
Time Frame	Baseline and 48 hr post-procedure

Outcome Measure Data

Analysis Population Description

Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.

Arm/Group Title	Curette-First	IBT-First
Arm/Group Description	Use of curette prior to use of inflatable bone tamps	Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
Measure Participants	57	55
Back pain at baseline (n=57, 55)	7.7 (1.3)	7.5 (1.3)
Back pain at 48 hr post-procedure (n=57, 55)	3.0 (2.0)	3.3 (1.9)
Back pain change from baseline (n=57, 55)	-4.7 (1.9)	-4.2 (1.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Curette-First, IBT-First
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.144
	Comments
	Method	t-test, 2 sided
	Comments

8. Secondary Outcome

Title	Change in Ambulatory Status
Description	Ambulatory status was assessed by subjective patient questionnaire.
Time Frame	Baseline and 48 hrs post-procedure

Outcome Measure Data

Analysis Population Description

Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.

Arm/Group Title	Curette-First	IBT-First
Arm/Group Description	Use of curette prior to use of inflatable bone tamps	Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
Measure Participants	57	55
Able to walk without assistance -- baseline	36 63.2%	34 61.8%
Able to walk with aid -- baseline	18 31.6%	21 38.2%
Must use wheelchair or bedridden -- baseline	3 5.3%	0 0%
Able to walk without assistance -- 48 hrs post-op	48 84.2%	42 76.4%
Able to walk with aid -- 48 hrs post-op	9 15.8%	12 21.8%
Must use wheelchair or bedridden -- 48 hrs post-op	0 0%	1 1.8%
No change	43 75.4%	40 72.7%
Improved	13 22.8%	11 20%
Worsened	1 1.8%	4 7.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Curette-First, IBT-First
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.360
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Arm/Group Title	Curette-First		IBT-First
Arm/Group Description	Use of the curette prior to use of the inflatable bone tamps		Use of the inflatable bone tamps prior to using the curette
All Cause Mortality
	Curette-First		IBT-First
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Curette-First		IBT-First
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/57 (8.8%)		8/55 (14.5%)
Cardiac disorders
Atrial fibrillation	1/57 (1.8%)	1	0/55 (0%)	0
Gastrointestinal disorders
Abdominal pain upper	0/57 (0%)	0	1/55 (1.8%)	1
Infections and infestations
Diverticulitis	0/57 (0%)	0	1/55 (1.8%)	1
Lung infection	0/57 (0%)	0	1/55 (1.8%)	1
Post procedural pneumonia	1/57 (1.8%)	1	0/55 (0%)	0
Septic shock	1/57 (1.8%)	1	0/55 (0%)	0
Urinary tract infection	0/57 (0%)	0	1/55 (1.8%)	1
Injury, poisoning and procedural complications
Thoracic vertebral fracture	1/57 (1.8%)	1	1/55 (1.8%)	1
Musculoskeletal and connective tissue disorders
Back pain	0/57 (0%)	0	2/55 (3.6%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal meningioma benign	0/57 (0%)	0	1/55 (1.8%)	1
Psychiatric disorders
Psychiatric decompensation	1/57 (1.8%)	1	0/55 (0%)	0
Reproductive system and breast disorders
Benign prostatic hyperplasia	0/57 (0%)	0	1/55 (1.8%)	1
Other (Not Including Serious) Adverse Events
	Curette-First		IBT-First
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/57 (21.1%)		11/55 (20%)
Ear and labyrinth disorders
Vertigo	0/57 (0%)	0	1/55 (1.8%)	1
Gastrointestinal disorders
Abdominal pain upper	1/57 (1.8%)	1	0/55 (0%)	0
Constipation	0/57 (0%)	0	1/55 (1.8%)	1
Diarrhoea	0/57 (0%)	0	1/55 (1.8%)	1
Gastritis	1/57 (1.8%)	1	0/55 (0%)	0
Procedural vomiting	1/57 (1.8%)	1	0/55 (0%)	0
Vomiting	1/57 (1.8%)	1	0/55 (0%)	0
General disorders
Adverse drug reaction	1/57 (1.8%)	1	0/55 (0%)	0
Infections and infestations
Helicobacter gastritis	0/57 (0%)	0	1/55 (1.8%)	1
Urinary tract infection	0/57 (0%)	0	1/55 (1.8%)	1
Injury, poisoning and procedural complications
Incision site pain	1/57 (1.8%)	1	0/55 (0%)	0
Post procedural haematoma	0/57 (0%)	0	1/55 (1.8%)	1
Procedural pain	0/57 (0%)	0	1/55 (1.8%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	1/57 (1.8%)	1	0/55 (0%)	0
Back pain	1/57 (1.8%)	1	2/55 (3.6%)	2
Musculoskeletal pain	0/57 (0%)	0	1/55 (1.8%)	1
Pain in extremity	1/57 (1.8%)	1	0/55 (0%)	0
Nervous system disorders
Confusion postoperative	2/57 (3.5%)	2	0/55 (0%)	0
Headache	2/57 (3.5%)	2	1/55 (1.8%)	1
Psychiatric disorders
Anxiety	1/57 (1.8%)	1	0/55 (0%)	0
Confusional state	0/57 (0%)	0	1/55 (1.8%)	1
Vascular disorders
Hypertension	0/57 (0%)	0	1/55 (1.8%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.