Trial Outcomes & Findings for INFUSE®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine (NCT NCT01415908)
NCT ID: NCT01415908
Last Updated: 2016-02-18
Results Overview
Rate of overall success is reported as percent of subjects who met all of the following criteria: 1. fusion at all treated levels (e.g., one level for a one level fusion and two levels for a two level fusion); 2. pain/disability (Oswestry Disability Index) success; 3. neurological status success; 4. no serious adverse event classified as "implant associated" or "implant/surgical procedure associated"; 5. no additional surgical procedure classified as a "failure."
TERMINATED
PHASE3
15 participants
24 months
2016-02-18
Participant Flow
Participant milestones
| Measure |
Investigational Group
Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
|
Control Group
Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
4
|
|
Overall Study
COMPLETED
|
10
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Investigational Group
Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
|
Control Group
Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
INFUSE®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine
Baseline characteristics by cohort
| Measure |
Investigational Group
n=11 Participants
Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
|
Control Group
n=4 Participants
Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.5 years
STANDARD_DEVIATION 11.88 • n=5 Participants
|
56.2 years
STANDARD_DEVIATION 12.26 • n=7 Participants
|
52.0 years
STANDARD_DEVIATION 11.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
9 participants
n=5 Participants
|
4 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Height
|
67.6 Inches
STANDARD_DEVIATION 3.35 • n=5 Participants
|
68.5 Inches
STANDARD_DEVIATION 3.87 • n=7 Participants
|
67.9 Inches
STANDARD_DEVIATION 3.38 • n=5 Participants
|
|
Weight
|
179.7 lbs
STANDARD_DEVIATION 37.25 • n=5 Participants
|
183.5 lbs
STANDARD_DEVIATION 38.10 • n=7 Participants
|
180.7 lbs
STANDARD_DEVIATION 36.13 • n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsRate of overall success is reported as percent of subjects who met all of the following criteria: 1. fusion at all treated levels (e.g., one level for a one level fusion and two levels for a two level fusion); 2. pain/disability (Oswestry Disability Index) success; 3. neurological status success; 4. no serious adverse event classified as "implant associated" or "implant/surgical procedure associated"; 5. no additional surgical procedure classified as a "failure."
Outcome measures
| Measure |
Investigational Group
n=10 Participants
Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
|
Control Group
n=4 Participants
Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
|
|---|---|---|
|
Rate of Overall Success
|
70.0 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Eight investigational and 3 control subjects were evaluated for fusion success at 24 months.
Rate of fusion success is reported as percent of subjects having fusion success. The fusion success was defined radiologically as: 1. evidence of bridging bone; 2. no evidence of motion; 3. no evidence of radiolucency at greater than 50% of the superior or inferior PEEK spacer-vertebra interface.
Outcome measures
| Measure |
Investigational Group
n=8 Participants
Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
|
Control Group
n=3 Participants
Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
|
|---|---|---|
|
Rate of Fusion Success
|
100.0 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: 24 monthsODI 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). Success rate of Oswestry Disability Index (ODI) is reported as percent of subjects whose ODI score met: pre-operative score - post-operative score ≥ 15.
Outcome measures
| Measure |
Investigational Group
n=10 Participants
Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
|
Control Group
n=4 Participants
Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
|
|---|---|---|
|
Success Rate of Oswestry Disability Index
|
90.0 percentage of participants
|
75.0 percentage of participants
|
SECONDARY outcome
Timeframe: 24 monthsNeurological status was assessed in six sections: motor, sensory, reflexes, straight leg raising, bowel function, and bladder function. Each of the sections had a number of elements. Success rate of neurological status is reported as percent of subjects whose neurological status was maintained or improved in three key neurological assessments-motor, sensory, and deep tendon reflexes.
Outcome measures
| Measure |
Investigational Group
n=10 Participants
Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
|
Control Group
n=4 Participants
Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
|
|---|---|---|
|
Success Rate of Neurological Status
|
80.0 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: 24 monthsNumerical rating scales were used to evaluate back pain intensity and frequency. Subjects rated their back pain intensity 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." Similarly, subjects recorded their back pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total back pain score were the sum of pain intensity and frequency scores. Success rate of back pain is reported as percent of subjects whose back pain improvement met: pre-operative score - post-operative score \> 0.
Outcome measures
| Measure |
Investigational Group
n=10 Participants
Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
|
Control Group
n=4 Participants
Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
|
|---|---|---|
|
Success Rate of Back Pain
|
100.0 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: 24 monthsNumerical rating scales were used to evaluate leg pain intensity and frequency. Subjects rated their leg pain intensity 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." Similarly, subjects recorded their leg pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total leg pain score were the sum of pain intensity and frequency scores. Success rate of leg pain is reported as percent of subjects whose leg pain improvement met: pre-operative score - post-operative score \> 0.
Outcome measures
| Measure |
Investigational Group
n=10 Participants
Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
|
Control Group
n=4 Participants
Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
|
|---|---|---|
|
Success Rate of Leg Pain
|
90.0 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: 24 monthsThe Medical Outcomes Study 36-Item Short Form (SF-36) health survey was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The scores for PCS and MCS are between 0 and 100, with higher scores denoting better quality of life. To be classified as a success, the following criteria must be met for SF-36 PCS and MCS, respectively: post-operative score - pre-operative score \>= 0. The results are reported as percent of subjects who have SF-36 PCS success, SF-36 MCS success, and overall SF-36 success.
Outcome measures
| Measure |
Investigational Group
n=10 Participants
Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
|
Control Group
n=4 Participants
Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
|
|---|---|---|
|
Success Rate of General Health Status
Overall SF-36 success
|
70.0 percentage of participants
|
75.0 percentage of participants
|
|
Success Rate of General Health Status
Success of SF-36 PCS
|
80.0 percentage of participants
|
100.0 percentage of participants
|
|
Success Rate of General Health Status
Success of SF-36 MCS
|
80.0 percentage of participants
|
75.0 percentage of participants
|
SECONDARY outcome
Timeframe: 24 monthsOutcome measures
| Measure |
Investigational Group
n=11 Participants
Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
|
Control Group
n=4 Participants
Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
|
|---|---|---|
|
Percent of Subjects Who Had Additional Surgical Procedures/Interventions
|
18.2 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Operative time was recorded from skin incision to wound closureOutcome measures
| Measure |
Investigational Group
n=11 Participants
Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
|
Control Group
n=4 Participants
Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
|
|---|---|---|
|
Operative Time
|
200.0 minutes
Standard Deviation 114.24
|
281.5 minutes
Standard Deviation 38.17
|
SECONDARY outcome
Timeframe: During the operation, an average of 200 minutes for investigational group and 281.5 minutes for control groupOutcome measures
| Measure |
Investigational Group
n=11 Participants
Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
|
Control Group
n=4 Participants
Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
|
|---|---|---|
|
Blood Loss
|
322.7 mls
Standard Deviation 267.73
|
200.0 mls
Standard Deviation 191.49
|
SECONDARY outcome
Timeframe: During the time of hospital stayOutcome measures
| Measure |
Investigational Group
n=11 Participants
Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
|
Control Group
n=4 Participants
Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
|
|---|---|---|
|
Hospital Stay
|
4.2 days
Standard Deviation 1.17
|
4.5 days
Standard Deviation 1.00
|
Adverse Events
Investigational Group
Control Group
Serious adverse events
| Measure |
Investigational Group
n=11 participants at risk
Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
|
Control Group
n=4 participants at risk
Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
|
|---|---|---|
|
Injury, poisoning and procedural complications
post laminectomy syndrome
|
0.00%
0/11 • 24 months
|
25.0%
1/4 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Seroma
|
9.1%
1/11 • Number of events 1 • 24 months
|
0.00%
0/4 • 24 months
|
|
Musculoskeletal and connective tissue disorders
extraskeletal ossification
|
9.1%
1/11 • Number of events 1 • 24 months
|
0.00%
0/4 • 24 months
|
|
Musculoskeletal and connective tissue disorders
pseudarthrosis
|
9.1%
1/11 • Number of events 1 • 24 months
|
0.00%
0/4 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
squamous cell carcinoma
|
9.1%
1/11 • Number of events 1 • 24 months
|
0.00%
0/4 • 24 months
|
|
Nervous system disorders
lumbar radiculopathy
|
9.1%
1/11 • Number of events 1 • 24 months
|
0.00%
0/4 • 24 months
|
|
Nervous system disorders
radiculitis
|
9.1%
1/11 • Number of events 1 • 24 months
|
0.00%
0/4 • 24 months
|
|
Nervous system disorders
radiculopathy
|
9.1%
1/11 • Number of events 1 • 24 months
|
0.00%
0/4 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
9.1%
1/11 • Number of events 1 • 24 months
|
0.00%
0/4 • 24 months
|
Other adverse events
| Measure |
Investigational Group
n=11 participants at risk
Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
|
Control Group
n=4 participants at risk
Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
|
|---|---|---|
|
Blood and lymphatic system disorders
haemorrhagic anaemia
|
9.1%
1/11 • Number of events 1 • 24 months
|
0.00%
0/4 • 24 months
|
|
Gastrointestinal disorders
constipation
|
9.1%
1/11 • Number of events 1 • 24 months
|
0.00%
0/4 • 24 months
|
|
Gastrointestinal disorders
dyspepsia
|
0.00%
0/11 • 24 months
|
25.0%
1/4 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
nausea
|
9.1%
1/11 • Number of events 1 • 24 months
|
0.00%
0/4 • 24 months
|
|
Gastrointestinal disorders
vomiting
|
9.1%
1/11 • Number of events 1 • 24 months
|
0.00%
0/4 • 24 months
|
|
General disorders
oedema peripheral
|
9.1%
1/11 • Number of events 1 • 24 months
|
0.00%
0/4 • 24 months
|
|
General disorders
pyrexia
|
18.2%
2/11 • Number of events 3 • 24 months
|
25.0%
1/4 • Number of events 1 • 24 months
|
|
Infections and infestations
influenza
|
9.1%
1/11 • Number of events 1 • 24 months
|
0.00%
0/4 • 24 months
|
|
Infections and infestations
sinusitis
|
9.1%
1/11 • Number of events 2 • 24 months
|
0.00%
0/4 • 24 months
|
|
Injury, poisoning and procedural complications
dural tear
|
0.00%
0/11 • 24 months
|
25.0%
1/4 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
fall
|
9.1%
1/11 • Number of events 1 • 24 months
|
0.00%
0/4 • 24 months
|
|
Investigations
vitamin D decreased
|
9.1%
1/11 • Number of events 1 • 24 months
|
0.00%
0/4 • 24 months
|
|
Metabolism and nutrition disorders
diabetes mellitus
|
9.1%
1/11 • Number of events 1 • 24 months
|
0.00%
0/4 • 24 months
|
|
Metabolism and nutrition disorders
hypokalaemia
|
0.00%
0/11 • 24 months
|
25.0%
1/4 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
18.2%
2/11 • Number of events 4 • 24 months
|
0.00%
0/4 • 24 months
|
|
Musculoskeletal and connective tissue disorders
back pain
|
18.2%
2/11 • Number of events 2 • 24 months
|
0.00%
0/4 • 24 months
|
|
Musculoskeletal and connective tissue disorders
groin pain
|
18.2%
2/11 • Number of events 2 • 24 months
|
0.00%
0/4 • 24 months
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
9.1%
1/11 • Number of events 1 • 24 months
|
0.00%
0/4 • 24 months
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
9.1%
1/11 • Number of events 1 • 24 months
|
0.00%
0/4 • 24 months
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
18.2%
2/11 • Number of events 2 • 24 months
|
0.00%
0/4 • 24 months
|
|
Nervous system disorders
headache
|
0.00%
0/11 • 24 months
|
25.0%
1/4 • Number of events 2 • 24 months
|
|
Nervous system disorders
hypoaesthesia
|
0.00%
0/11 • 24 months
|
25.0%
1/4 • Number of events 1 • 24 months
|
|
Nervous system disorders
paraesthesia
|
9.1%
1/11 • Number of events 1 • 24 months
|
0.00%
0/4 • 24 months
|
|
Nervous system disorders
sensory disturbance
|
0.00%
0/11 • 24 months
|
25.0%
1/4 • Number of events 1 • 24 months
|
|
Renal and urinary disorders
urinary incontinence
|
9.1%
1/11 • Number of events 1 • 24 months
|
0.00%
0/4 • 24 months
|
|
Renal and urinary disorders
urinary retention
|
9.1%
1/11 • Number of events 2 • 24 months
|
25.0%
1/4 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
9.1%
1/11 • Number of events 1 • 24 months
|
0.00%
0/4 • 24 months
|
|
Skin and subcutaneous tissue disorders
night sweats
|
9.1%
1/11 • Number of events 1 • 24 months
|
0.00%
0/4 • 24 months
|
|
Skin and subcutaneous tissue disorders
swelling face
|
0.00%
0/11 • 24 months
|
25.0%
1/4 • Number of events 1 • 24 months
|
|
Vascular disorders
hot flush
|
9.1%
1/11 • Number of events 1 • 24 months
|
0.00%
0/4 • 24 months
|
|
Vascular disorders
hypertension
|
9.1%
1/11 • Number of events 1 • 24 months
|
0.00%
0/4 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60