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INFUSE®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine (TLIF)

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ClinicalTrials.gov Identifier: NCT01415908
Recruitment Status : Terminated (Due to study design challenges including DMC enrollment suspension as required by the protocol stopping rules and recommended changes to the surgical technique)
First Posted : August 12, 2011
Results First Posted : October 28, 2015
Last Update Posted : February 18, 2016
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lumbar Spine Degeneration
Interventions Device: INFUSE Bone Graft
Other: Iliac Crest Bone Graft
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Investigational Group Control Group
Hide Arm/Group Description Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach. 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.
Period Title: Overall Study
Started 11 4
Completed 10 4
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Investigational Group Control Group Total
Hide Arm/Group Description Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach. 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 of all reporting groups
Overall Number of Baseline Participants 11 4 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 4 participants 15 participants
50.5  (11.88) 56.2  (12.26) 52.0  (11.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 4 participants 15 participants
Female
5
  45.5%
2
  50.0%
7
  46.7%
Male
6
  54.5%
2
  50.0%
8
  53.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants 4 participants 15 participants
Caucasian 9 4 13
Black 0 0 0
Asian 2 0 2
Hispanic 0 0 0
Other 0 0 0
Height  
Mean (Standard Deviation)
Unit of measure:  Inches
Number Analyzed 11 participants 4 participants 15 participants
67.6  (3.35) 68.5  (3.87) 67.9  (3.38)
Weight  
Mean (Standard Deviation)
Unit of measure:  Lbs
Number Analyzed 11 participants 4 participants 15 participants
179.7  (37.25) 183.5  (38.10) 180.7  (36.13)
1.Primary Outcome
Title Rate of Overall Success
Hide Description

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."
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Investigational Group Control Group
Hide Arm/Group Description:
Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
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 Number of Participants Analyzed 10 4
Measure Type: Number
Unit of Measure: percentage of participants
70.0 50.0
2.Secondary Outcome
Title Rate of Fusion Success
Hide Description

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.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Eight investigational and 3 control subjects were evaluated for fusion success at 24 months.
Arm/Group Title Investigational Group Control Group
Hide Arm/Group Description:
Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
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 Number of Participants Analyzed 8 3
Measure Type: Number
Unit of Measure: percentage of participants
100.0 100.0
3.Secondary Outcome
Title Success Rate of Oswestry Disability Index
Hide Description 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). Success rate of Oswestry Disability Index (ODI) is reported as percent of subjects whose ODI score met: pre-operative score - post-operative score ≥ 15.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Investigational Group Control Group
Hide Arm/Group Description:
Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
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 Number of Participants Analyzed 10 4
Measure Type: Number
Unit of Measure: percentage of participants
90.0 75.0
4.Secondary Outcome
Title Success Rate of Neurological Status
Hide Description Neurological 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.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Investigational Group Control Group
Hide Arm/Group Description:
Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
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 Number of Participants Analyzed 10 4
Measure Type: Number
Unit of Measure: percentage of participants
80.0 50.0
5.Secondary Outcome
Title Success Rate of Back Pain
Hide Description Numerical 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.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Investigational Group Control Group
Hide Arm/Group Description:
Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
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 Number of Participants Analyzed 10 4
Measure Type: Number
Unit of Measure: percentage of participants
100.0 100.0
6.Secondary Outcome
Title Success Rate of Leg Pain
Hide Description Numerical 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.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Investigational Group Control Group
Hide Arm/Group Description:
Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
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 Number of Participants Analyzed 10 4
Measure Type: Number
Unit of Measure: percentage of participants
90.0 100.0
7.Secondary Outcome
Title Success Rate of General Health Status
Hide Description The 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.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Investigational Group Control Group
Hide Arm/Group Description:
Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
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 Number of Participants Analyzed 10 4
Measure Type: Number
Unit of Measure: percentage of participants
Overall SF-36 success 70.0 75.0
Success of SF-36 PCS 80.0 100.0
Success of SF-36 MCS 80.0 75.0
8.Secondary Outcome
Title Percent of Subjects Who Had Additional Surgical Procedures/Interventions
Hide Description [Not Specified]
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Investigational Group Control Group
Hide Arm/Group Description:
Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
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 Number of Participants Analyzed 11 4
Measure Type: Number
Unit of Measure: percentage of participants
18.2 50.0
9.Secondary Outcome
Title Operative Time
Hide Description [Not Specified]
Time Frame Operative time was recorded from skin incision to wound closure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Investigational Group Control Group
Hide Arm/Group Description:
Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
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 Number of Participants Analyzed 11 4
Mean (Standard Deviation)
Unit of Measure: minutes
200.0  (114.24) 281.5  (38.17)
10.Secondary Outcome
Title Blood Loss
Hide Description [Not Specified]
Time Frame During the operation, an average of 200 minutes for investigational group and 281.5 minutes for control group
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Investigational Group Control Group
Hide Arm/Group Description:
Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
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 Number of Participants Analyzed 11 4
Mean (Standard Deviation)
Unit of Measure: mls
322.7  (267.73) 200.0  (191.49)
11.Secondary Outcome
Title Hospital Stay
Hide Description [Not Specified]
Time Frame During the time of hospital stay
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Investigational Group Control Group
Hide Arm/Group Description:
Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
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 Number of Participants Analyzed 11 4
Mean (Standard Deviation)
Unit of Measure: days
4.2  (1.17) 4.5  (1.00)
Time Frame 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Investigational Group Control Group
Hide Arm/Group Description Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach. 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.
All-Cause Mortality
Investigational Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Investigational Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/11 (27.27%)      1/4 (25.00%)    
Injury, poisoning and procedural complications     
post laminectomy syndrome  0/11 (0.00%)  0 1/4 (25.00%)  1
Seroma  1/11 (9.09%)  1 0/4 (0.00%)  0
Musculoskeletal and connective tissue disorders     
extraskeletal ossification  1/11 (9.09%)  1 0/4 (0.00%)  0
pseudarthrosis  1/11 (9.09%)  1 0/4 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
squamous cell carcinoma  1/11 (9.09%)  1 0/4 (0.00%)  0
Nervous system disorders     
lumbar radiculopathy  1/11 (9.09%)  1 0/4 (0.00%)  0
radiculitis  1/11 (9.09%)  1 0/4 (0.00%)  0
radiculopathy  1/11 (9.09%)  1 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
pulmonary embolism  1/11 (9.09%)  1 0/4 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.0%
Investigational Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/11 (81.82%)      1/4 (25.00%)    
Blood and lymphatic system disorders     
haemorrhagic anaemia  1/11 (9.09%)  1 0/4 (0.00%)  0
Gastrointestinal disorders     
constipation  1/11 (9.09%)  1 0/4 (0.00%)  0
dyspepsia  0/11 (0.00%)  0 1/4 (25.00%)  1
nausea  1/11 (9.09%)  1 0/4 (0.00%)  0
vomiting  1/11 (9.09%)  1 0/4 (0.00%)  0
General disorders     
oedema peripheral  1/11 (9.09%)  1 0/4 (0.00%)  0
pyrexia  2/11 (18.18%)  3 1/4 (25.00%)  1
Infections and infestations     
influenza  1/11 (9.09%)  1 0/4 (0.00%)  0
sinusitis  1/11 (9.09%)  2 0/4 (0.00%)  0
Injury, poisoning and procedural complications     
dural tear  0/11 (0.00%)  0 1/4 (25.00%)  1
fall  1/11 (9.09%)  1 0/4 (0.00%)  0
Investigations     
vitamin D decreased  1/11 (9.09%)  1 0/4 (0.00%)  0
Metabolism and nutrition disorders     
diabetes mellitus  1/11 (9.09%)  1 0/4 (0.00%)  0
hypokalaemia  0/11 (0.00%)  0 1/4 (25.00%)  1
Musculoskeletal and connective tissue disorders     
arthralgia  2/11 (18.18%)  4 0/4 (0.00%)  0
back pain  2/11 (18.18%)  2 0/4 (0.00%)  0
groin pain  2/11 (18.18%)  2 0/4 (0.00%)  0
musculoskeletal pain  1/11 (9.09%)  1 0/4 (0.00%)  0
myalgia  1/11 (9.09%)  1 0/4 (0.00%)  0
pain in extremity  2/11 (18.18%)  2 0/4 (0.00%)  0
Nervous system disorders     
headache  0/11 (0.00%)  0 1/4 (25.00%)  2
hypoaesthesia  0/11 (0.00%)  0 1/4 (25.00%)  1
paraesthesia  1/11 (9.09%)  1 0/4 (0.00%)  0
sensory disturbance  0/11 (0.00%)  0 1/4 (25.00%)  1
Renal and urinary disorders     
urinary incontinence  1/11 (9.09%)  1 0/4 (0.00%)  0
urinary retention  1/11 (9.09%)  2 1/4 (25.00%)  1
Respiratory, thoracic and mediastinal disorders     
cough  1/11 (9.09%)  1 0/4 (0.00%)  0
Skin and subcutaneous tissue disorders     
night sweats  1/11 (9.09%)  1 0/4 (0.00%)  0
swelling face  0/11 (0.00%)  0 1/4 (25.00%)  1
Vascular disorders     
hot flush  1/11 (9.09%)  1 0/4 (0.00%)  0
hypertension  1/11 (9.09%)  1 0/4 (0.00%)  0
A total of 534 ± 10 subjects were planned for enrollment. However, this study was terminated early with only 15 enrolled patients, leading to small numbers of subjects analyzed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Clinical Department
Organization: Medtronic Spinal and Biologics
Phone: 1800-876-3133 ext 6068
Responsible Party: Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier: NCT01415908     History of Changes
Other Study ID Numbers: Medtronic P05-06
First Submitted: August 10, 2011
First Posted: August 12, 2011
Results First Submitted: September 25, 2015
Results First Posted: October 28, 2015
Last Update Posted: February 18, 2016