Trial Outcomes & Findings for Investigating Superion™ In Spinal Stenosis (NCT NCT00692276)
NCT ID: NCT00692276
Last Updated: 2020-11-16
Results Overview
Where clinically significant improvement in outcomes compared to baseline, as determined by meeting the following: * At least two of three domains of the Zurich Claudication Questionnaire (ZCQ) \[validated, condition-specific patient-reported questionnaire that captures data in three distinct domains\] * Improvement in physical function by ≥0.5 points * Improvement in symptom severity by ≥0.5 points * "Satisfied" or "somewhat satisfied" as defined by a score of ≤ 2.5 points on the patient satisfaction domain * No re-operations, revisions, removals or supplemental fixation at the index level(s) * No major implant- or procedure-related complications: * No dislodgement, migration, or deformation * No new or persistent worsened neurological deficit at the index level * No spinous process fractures * No deep infection, death, or other permanent device attributed disability * No clinically significant confounding treatments: * No epidural injections or nerve block proc
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
391 participants
Primary outcome timeframe
Baseline and 24 months
Results posted on
2020-11-16
Participant Flow
Participant milestones
| Measure |
1 - Study Treatment
Interspinous Process Spacer Device
Superion™ Interspinous Spacer: Implantation of interspinous process spacer to treat lumbar spinal stenosis
|
2 - Active Control Treatment
Interspinous Process Spacer Device
X-STOP® IPD® Device: Implantation of interspinous process spacer to treat lumbar spinal stenosis
|
|---|---|---|
|
Randomized Population
STARTED
|
190
|
201
|
|
Randomized Population
COMPLETED
|
190
|
201
|
|
Randomized Population
NOT COMPLETED
|
0
|
0
|
|
Completed 24 Months
STARTED
|
190
|
201
|
|
Completed 24 Months
COMPLETED
|
183
|
187
|
|
Completed 24 Months
NOT COMPLETED
|
7
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Investigating Superion™ In Spinal Stenosis
Baseline characteristics by cohort
| Measure |
1 - Study Treatment
n=190 Participants
Superion™ Interspinous Spacer
|
2 - Active Control Treatment
n=201 Participants
X-STOP® IPD® Device
|
Total
n=391 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
66.9 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
66.2 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
66.5 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
185 Participants
n=5 Participants
|
190 Participants
n=7 Participants
|
375 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 monthsWhere clinically significant improvement in outcomes compared to baseline, as determined by meeting the following: * At least two of three domains of the Zurich Claudication Questionnaire (ZCQ) \[validated, condition-specific patient-reported questionnaire that captures data in three distinct domains\] * Improvement in physical function by ≥0.5 points * Improvement in symptom severity by ≥0.5 points * "Satisfied" or "somewhat satisfied" as defined by a score of ≤ 2.5 points on the patient satisfaction domain * No re-operations, revisions, removals or supplemental fixation at the index level(s) * No major implant- or procedure-related complications: * No dislodgement, migration, or deformation * No new or persistent worsened neurological deficit at the index level * No spinous process fractures * No deep infection, death, or other permanent device attributed disability * No clinically significant confounding treatments: * No epidural injections or nerve block proc
Outcome measures
| Measure |
1 - Study Treatment
n=183 Participants
Interspinous Process Spacer Device
Superion™ Interspinous Spacer: Implantation of interspinous process spacer to treat lumbar spinal stenosis
|
2 - Active Control Treatment
n=187 Participants
Interspinous Process Spacer Device
X-STOP® IPD® Device: Implantation of interspinous process spacer to treat lumbar spinal stenosis
|
|---|---|---|
|
Percentage of Subjects With Clinically Significant Improvement in Outcomes
|
52.7 percentage of subjects
|
50.2 percentage of subjects
|
Adverse Events
1 - Study Treatment
Serious events: 113 serious events
Other events: 82 other events
Deaths: 7 deaths
2 - Active Control Treatment
Serious events: 117 serious events
Other events: 100 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
1 - Study Treatment
n=190 participants at risk
Interspinous Process Spacer Device
Superion™ Interspinous Spacer: Implantation of interspinous process spacer to treat lumbar spinal stenosis
|
2 - Active Control Treatment
n=201 participants at risk
Interspinous Process Spacer Device
X-STOP® IPD® Device: Implantation of interspinous process spacer to treat lumbar spinal stenosis
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.53%
1/190 • Number of events 1 • 60 Months
|
0.00%
0/201 • 60 Months
|
|
Immune system disorders
Allergic Reaction
|
1.1%
2/190 • Number of events 2 • 60 Months
|
0.50%
1/201 • Number of events 1 • 60 Months
|
|
Blood and lymphatic system disorders
Anemia
|
1.1%
2/190 • Number of events 3 • 60 Months
|
0.00%
0/201 • 60 Months
|
|
Cardiac disorders
Angina
|
1.1%
2/190 • Number of events 2 • 60 Months
|
0.00%
0/201 • 60 Months
|
|
Nervous system disorders
Cerebrovascular Accident (CVA)
|
1.1%
2/190 • Number of events 2 • 60 Months
|
0.50%
1/201 • Number of events 1 • 60 Months
|
|
Cardiac disorders
Coronary Episode, Ischemic
|
0.00%
0/190 • 60 Months
|
1.00%
2/201 • Number of events 5 • 60 Months
|
|
Infections and infestations
Deep Infection at the Operative Site
|
0.00%
0/190 • 60 Months
|
1.00%
2/201 • Number of events 3 • 60 Months
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.53%
1/190 • Number of events 1 • 60 Months
|
0.50%
1/201 • Number of events 1 • 60 Months
|
|
Nervous system disorders
Dizziness
|
1.1%
2/190 • Number of events 2 • 60 Months
|
0.00%
0/201 • 60 Months
|
|
Nervous system disorders
Dural Leak
|
3.2%
6/190 • Number of events 6 • 60 Months
|
1.00%
2/201 • Number of events 2 • 60 Months
|
|
Cardiac disorders
Dyspnea
|
0.00%
0/190 • 60 Months
|
0.50%
1/201 • Number of events 1 • 60 Months
|
|
General disorders
Edema
|
0.00%
0/190 • 60 Months
|
0.50%
1/201 • Number of events 1 • 60 Months
|
|
General disorders
Fever
|
0.00%
0/190 • 60 Months
|
1.00%
2/201 • Number of events 2 • 60 Months
|
|
Gastrointestinal disorders
Gastrointestional Bleed
|
0.53%
1/190 • Number of events 1 • 60 Months
|
0.50%
1/201 • Number of events 1 • 60 Months
|
|
Vascular disorders
Hematoma
|
0.00%
0/190 • 60 Months
|
0.50%
1/201 • Number of events 2 • 60 Months
|
|
Infections and infestations
Infection
|
1.1%
2/190 • Number of events 2 • 60 Months
|
0.50%
1/201 • Number of events 1 • 60 Months
|
|
Cardiac disorders
Myocardial Infarction
|
2.6%
5/190 • Number of events 5 • 60 Months
|
1.5%
3/201 • Number of events 3 • 60 Months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/190 • 60 Months
|
1.00%
2/201 • Number of events 2 • 60 Months
|
|
Nervous system disorders
Neurological Disorder
|
1.6%
3/190 • Number of events 3 • 60 Months
|
1.5%
3/201 • Number of events 3 • 60 Months
|
|
General disorders
Other
|
19.5%
37/190 • Number of events 48 • 60 Months
|
14.9%
30/201 • Number of events 38 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.8%
11/190 • Number of events 11 • 60 Months
|
7.0%
14/201 • Number of events 14 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Pain - Buttock or Groin
|
1.6%
3/190 • Number of events 3 • 60 Months
|
2.5%
5/201 • Number of events 6 • 60 Months
|
|
Infections and infestations
Pneumonia
|
3.2%
6/190 • Number of events 7 • 60 Months
|
1.00%
2/201 • Number of events 2 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Presence of Osteophyte Formation associated with Severe Disc or Facet Degeneration
|
0.00%
0/190 • 60 Months
|
0.50%
1/201 • Number of events 1 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.00%
0/190 • 60 Months
|
0.50%
1/201 • Number of events 1 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.53%
1/190 • Number of events 1 • 60 Months
|
0.00%
0/201 • 60 Months
|
|
Renal and urinary disorders
Renal Failure
|
1.6%
3/190 • Number of events 3 • 60 Months
|
0.50%
1/201 • Number of events 1 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Disorder
|
1.1%
2/190 • Number of events 2 • 60 Months
|
0.50%
1/201 • Number of events 1 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
1.1%
2/190 • Number of events 2 • 60 Months
|
0.00%
0/201 • 60 Months
|
|
Infections and infestations
Respiratory Infection
|
0.00%
0/190 • 60 Months
|
0.50%
1/201 • Number of events 1 • 60 Months
|
|
Injury, poisoning and procedural complications
Soft Tissue Damage
|
0.00%
0/190 • 60 Months
|
0.50%
1/201 • Number of events 1 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Spinal Stenosis Symptoms at Index Level
|
11.6%
22/190 • Number of events 23 • 60 Months
|
9.0%
18/201 • Number of events 19 • 60 Months
|
|
Injury, poisoning and procedural complications
Spinous Process Fracture
|
5.3%
10/190 • Number of events 11 • 60 Months
|
2.5%
5/201 • Number of events 5 • 60 Months
|
|
Nervous system disorders
Stroke
|
2.1%
4/190 • Number of events 4 • 60 Months
|
0.00%
0/201 • 60 Months
|
|
Nervous system disorders
Transient Ischemic Attack
|
0.00%
0/190 • 60 Months
|
0.50%
1/201 • Number of events 1 • 60 Months
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/190 • 60 Months
|
1.00%
2/201 • Number of events 2 • 60 Months
|
|
Injury, poisoning and procedural complications
Vertebral Compression Fracture
|
0.00%
0/190 • 60 Months
|
0.50%
1/201 • Number of events 1 • 60 Months
|
|
Injury, poisoning and procedural complications
Wound Dehiscence or Delayed Healing
|
0.00%
0/190 • 60 Months
|
0.50%
1/201 • Number of events 1 • 60 Months
|
|
Surgical and medical procedures
Wound Drainage
|
0.53%
1/190 • Number of events 1 • 60 Months
|
0.00%
0/201 • 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease (COPD)
|
0.53%
1/190 • Number of events 1 • 60 Months
|
0.00%
0/201 • 60 Months
|
|
Hepatobiliary disorders
Gallstones
|
0.00%
0/190 • 60 Months
|
0.50%
1/201 • Number of events 1 • 60 Months
|
|
Injury, poisoning and procedural complications
Injury, accidental
|
2.1%
4/190 • Number of events 5 • 60 Months
|
2.0%
4/201 • Number of events 4 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
5.8%
11/190 • Number of events 12 • 60 Months
|
6.5%
13/201 • Number of events 14 • 60 Months
|
|
Gastrointestinal disorders
Loss of bowel control
|
0.00%
0/190 • 60 Months
|
0.50%
1/201 • Number of events 1 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Adjacent level degenerative disk disease
|
0.53%
1/190 • Number of events 1 • 60 Months
|
0.00%
0/201 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Adjacent level stenosis
|
0.00%
0/190 • 60 Months
|
1.00%
2/201 • Number of events 3 • 60 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer/neoplasm
|
3.2%
6/190 • Number of events 7 • 60 Months
|
3.0%
6/201 • Number of events 6 • 60 Months
|
|
Cardiac disorders
Cardiovascular
|
3.7%
7/190 • Number of events 9 • 60 Months
|
3.5%
7/201 • Number of events 9 • 60 Months
|
|
General disorders
Device dislodgement
|
0.00%
0/190 • 60 Months
|
1.00%
2/201 • Number of events 2 • 60 Months
|
|
General disorders
Device migration
|
0.53%
1/190 • Number of events 1 • 60 Months
|
1.5%
3/201 • Number of events 4 • 60 Months
|
|
General disorders
Device subsidence
|
0.53%
1/190 • Number of events 1 • 60 Months
|
0.00%
0/201 • 60 Months
|
|
General disorders
Genitiurinary
|
4.2%
8/190 • Number of events 8 • 60 Months
|
2.0%
4/201 • Number of events 4 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
5.8%
11/190 • Number of events 12 • 60 Months
|
9.5%
19/201 • Number of events 21 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Pain - buttock
|
0.53%
1/190 • Number of events 1 • 60 Months
|
0.00%
0/201 • 60 Months
|
|
Gastrointestinal disorders
Gastrointestinal
|
2.1%
4/190 • Number of events 4 • 60 Months
|
1.5%
3/201 • Number of events 3 • 60 Months
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/190 • 60 Months
|
0.50%
1/201 • Number of events 1 • 60 Months
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/190 • 60 Months
|
0.50%
1/201 • Number of events 1 • 60 Months
|
Other adverse events
| Measure |
1 - Study Treatment
n=190 participants at risk
Interspinous Process Spacer Device
Superion™ Interspinous Spacer: Implantation of interspinous process spacer to treat lumbar spinal stenosis
|
2 - Active Control Treatment
n=201 participants at risk
Interspinous Process Spacer Device
X-STOP® IPD® Device: Implantation of interspinous process spacer to treat lumbar spinal stenosis
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer/Neoplasm
|
5.8%
11/190 • Number of events 13 • 60 Months
|
6.5%
13/201 • Number of events 14 • 60 Months
|
|
Cardiac disorders
Cardiovascular
|
10.5%
20/190 • Number of events 25 • 60 Months
|
8.0%
16/201 • Number of events 20 • 60 Months
|
|
Endocrine disorders
Endocrine/Metabolic
|
5.8%
11/190 • Number of events 11 • 60 Months
|
5.5%
11/201 • Number of events 13 • 60 Months
|
|
General disorders
Genitourinary
|
11.6%
22/190 • Number of events 25 • 60 Months
|
8.5%
17/201 • Number of events 17 • 60 Months
|
|
Infections and infestations
Infection
|
7.4%
14/190 • Number of events 15 • 60 Months
|
8.0%
16/201 • Number of events 17 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
41.1%
78/190 • Number of events 108 • 60 Months
|
34.8%
70/201 • Number of events 100 • 60 Months
|
|
Nervous system disorders
Neurological Disorder
|
11.6%
22/190 • Number of events 27 • 60 Months
|
6.5%
13/201 • Number of events 13 • 60 Months
|
|
General disorders
Other
|
7.4%
14/190 • Number of events 15 • 60 Months
|
2.5%
5/201 • Number of events 10 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
26.3%
50/190 • Number of events 56 • 60 Months
|
32.8%
66/201 • Number of events 71 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Pain - Buttock and Groin
|
11.1%
21/190 • Number of events 23 • 60 Months
|
6.5%
13/201 • Number of events 13 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Pain - Leg
|
19.5%
37/190 • Number of events 41 • 60 Months
|
23.4%
47/201 • Number of events 54 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Spinal Stenosis at Index Level
|
18.4%
35/190 • Number of events 37 • 60 Months
|
16.9%
34/201 • Number of events 38 • 60 Months
|
|
Musculoskeletal and connective tissue disorders
Spinal Process Fracture
|
11.6%
22/190 • Number of events 24 • 60 Months
|
6.5%
13/201 • Number of events 14 • 60 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place