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Trial record 10 of 147 for:    "Spondylolysis"

Human Amniotic Tissue-derived Allograft, NuCel, in Posteriolateral Lumbar Fusions for Degenerative Disc Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02070484
Recruitment Status : Terminated (Poor enrollment)
First Posted : February 25, 2014
Results First Posted : August 27, 2018
Last Update Posted : September 28, 2018
Sponsor:
Collaborator:
NuTech Medical, Inc
Information provided by (Responsible Party):
Joseph A. Shehadi, MD, OhioHealth

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Lumbar Degenerative Disc Disease
Spinal Stenosis
Spondylolisthesis
Spondylosis
Intervertebral Disk Displacement
Intervertebral Disk Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Interventions Biological: NuCel
Biological: Demineralized Bone Matrix
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title NuCel Demineralized Bone Matrix (DBM)
Hide Arm/Group Description

Stemcell allograft

NuCel

Demineralized Bone Matrix (DBM) bone graft substitute

Demineralized Bone Matrix

Period Title: Overall Study
Started 3 3
Completed 2 3
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title NuCel Demineralized Bone Matrix (DBM) Total
Hide Arm/Group Description

Stemcell allograft

NuCel

Demineralized Bone Matrix (DBM) bone graft substitute

Demineralized Bone Matrix

Total of all reporting groups
Overall Number of Baseline Participants 3 3 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
3
 100.0%
6
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
Female
2
  66.7%
2
  66.7%
4
  66.7%
Male
1
  33.3%
1
  33.3%
2
  33.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Oswestry Disability Index   [1] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 3 participants 3 participants 6 participants
28.7
(26 to 32)
26.7
(19 to 34)
27.7
(19 to 34)
[1]
Measure Description: The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.
1.Primary Outcome
Title Oswestry Disability Index
Hide Description The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
One of three NuCel patients withdrew before 12 months; therefore, analysis comprises two NuCel patients and three DBM patients.
Arm/Group Title NuCel Demineralized Bone Matrix (DBM)
Hide Arm/Group Description:

Stemcell allograft

NuCel

Demineralized Bone Matrix (DBM) bone graft substitute

Demineralized Bone Matrix

Overall Number of Participants Analyzed 2 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.0  (11.3) 15.3  (17.2)
2.Primary Outcome
Title Oswestry Disability Index
Hide Description The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NuCel Demineralized Bone Matrix (DBM)
Hide Arm/Group Description:

Stemcell allograft

NuCel

Demineralized Bone Matrix (DBM) bone graft substitute

Demineralized Bone Matrix

Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
28.7  (3.1) 26.7  (7.5)
3.Primary Outcome
Title Oswestry Disability Index
Hide Description The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
One of three NuCel patients withdrew; therefore, analysis comprises two NuCel patients and three DBM patients.
Arm/Group Title NuCel Demineralized Bone Matrix (DBM)
Hide Arm/Group Description:

Stemcell allograft

NuCel

Demineralized Bone Matrix (DBM) bone graft substitute

Demineralized Bone Matrix

Overall Number of Participants Analyzed 2 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
15.5  (12.0) 26.7  (13.7)
4.Primary Outcome
Title Oswestry Disability Index
Hide Description The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
One of three NuCel patients withdrew; therefore, analysis comprises two NuCel patients and three DBM patients.
Arm/Group Title NuCel Demineralized Bone Matrix (DBM)
Hide Arm/Group Description:

Stemcell allograft

NuCel

Demineralized Bone Matrix (DBM) bone graft substitute

Demineralized Bone Matrix

Overall Number of Participants Analyzed 2 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
19.5  (17.7) 22.0  (9.6)
5.Primary Outcome
Title Oswestry Disability Index
Hide Description The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
One of three NuCel patients withdrew; therefore, analysis comprises two NuCel patients and three DBM patients.
Arm/Group Title NuCel Demineralized Bone Matrix (DBM)
Hide Arm/Group Description:

Stemcell allograft

NuCel

Demineralized Bone Matrix (DBM) bone graft substitute

Demineralized Bone Matrix

Overall Number of Participants Analyzed 2 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
10.0  (12.7) 25.7  (7.5)
6.Primary Outcome
Title Oswestry Disability Index
Hide Description The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
One of three NuCel patients withdrew; therefore, analysis comprises two NuCel patients and three DBM patients.
Arm/Group Title NuCel Demineralized Bone Matrix (DBM)
Hide Arm/Group Description:

Stemcell allograft

NuCel

Demineralized Bone Matrix (DBM) bone graft substitute

Demineralized Bone Matrix

Overall Number of Participants Analyzed 2 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.5  (9.2) 14.7  (10.6)
7.Secondary Outcome
Title Computed Tomography (CT) Scans to Assess Lumbar Bone Fusion
Hide Description CT scans reviewed by an independent radiologist and scored according to three categories: no fusion, any fusion, solid fusion.
Time Frame 6 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated due to low enrollment; therefore, CT scans at 6 and 12 months were not conducted.
Arm/Group Title NuCel Demineralized Bone Matrix (DBM)
Hide Arm/Group Description:

Stemcell allograft

NuCel

Demineralized Bone Matrix (DBM) bone graft substitute

Demineralized Bone Matrix

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were recorded through 12 months post-operatively
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NuCel Demineralized Bone Matrix (DBM)
Hide Arm/Group Description

Stemcell allograft

NuCel

Demineralized Bone Matrix (DBM) bone graft substitute

Demineralized Bone Matrix

All-Cause Mortality
NuCel Demineralized Bone Matrix (DBM)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)      0/3 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
NuCel Demineralized Bone Matrix (DBM)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      1/3 (33.33%)    
Gastrointestinal disorders     
Prolonged hospitalization * [1]  0/3 (0.00%)  0 1/3 (33.33%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Intermittent diarrhea, bloating, and stomach pain beginning post-operative day 5. Symptoms improved with bowel regimen and liquid diet; solid food resumed post-operative day 5. Patient discharged post-operative day 5.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
NuCel Demineralized Bone Matrix (DBM)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/3 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Josepha Shehadi, MD
Organization: OhioHealth
Phone: 614-220-5648
Responsible Party: Joseph A. Shehadi, MD, OhioHealth
ClinicalTrials.gov Identifier: NCT02070484     History of Changes
Other Study ID Numbers: OH2-13-0034
First Submitted: February 21, 2014
First Posted: February 25, 2014
Results First Submitted: April 13, 2018
Results First Posted: August 27, 2018
Last Update Posted: September 28, 2018