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Clinical Outcomes of the Trinica(R) Anterior Lumbar Plate: Fixed Screws vs. Variable Screws

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ClinicalTrials.gov Identifier: NCT00762723
Recruitment Status : Terminated (Study was stopped due to slow enrollment)
First Posted : September 30, 2008
Results First Posted : March 26, 2014
Last Update Posted : April 17, 2014
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Degenerative Disc Disease
Spinal Stenosis
Spondylolisthesis
Intervention Device: Trinica Anterior Lumbar Plate System
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ALP With Fixed Screws ALP With Variable Screws ALP With Hybrid Screws
Hide Arm/Group Description

Trinica Anterior Lumbar Plate System with fixed screws only

Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration.

Trinica Anterior Lumbar Plate System with variable screws only

Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration.

Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws).

Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration.

Period Title: Overall Study
Started 5 11 3
Completed 0 6 0
Not Completed 5 5 3
Reason Not Completed
Study Terminated slow enrollement             5             5             3
Arm/Group Title Group 1 Group 2 Group 3 Total
Hide Arm/Group Description

Trinica Anterior Lumbar Plate System with fixed screws only

Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration.

Trinica Anterior Lumbar Plate System with variable screws only

Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration.

Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws).

Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration.

Total of all reporting groups
Overall Number of Baseline Participants 5 11 3 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants 11 participants 3 participants 19 participants
54
(45 to 66)
51
(35 to 74)
45
(33 to 55)
51
(33 to 74)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 11 participants 3 participants 19 participants
Female
1
  20.0%
6
  54.5%
1
  33.3%
8
  42.1%
Male
4
  80.0%
5
  45.5%
2
  66.7%
11
  57.9%
[1]
Measure Description: Number
1.Primary Outcome
Title Clinical Outcomes (Oswestry Disability Index, SF-12, Numeric Pain Rating Scale, Surgeon Assessment, Patient Self Assessment, Radiological Assessment)
Hide Description - Fusion Assessment
Time Frame Pre-operative, Operative; Follow-ups at 3 Months, 6 Months, 12 Months, and 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Data not analyzed because study was stopped due to slow enrollment.
Arm/Group Title Group 1 Group 2 Group 3
Hide Arm/Group Description:

Trinica Anterior Lumbar Plate System with fixed screws only

Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration.

Trinica Anterior Lumbar Plate System with variable screws only

Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration.

Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws).

Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 Group 2 Group 3
Hide Arm/Group Description

Trinica Anterior Lumbar Plate System with fixed screws only

Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration.

Trinica Anterior Lumbar Plate System with variable screws only

Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration.

Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws).

Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration.

All-Cause Mortality
Group 1 Group 2 Group 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 Group 2 Group 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/5 (20.00%)      0/11 (0.00%)      0/3 (0.00%)    
Musculoskeletal and connective tissue disorders       
Cervical Disc Disease [1]  1/5 (20.00%)  0/11 (0.00%)  0/3 (0.00%) 
[1]
Pt. developed cervical disc disease, had surgery for cervical fusion
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1 Group 2 Group 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/5 (80.00%)      4/11 (36.36%)      0/3 (0.00%)    
Gastrointestinal disorders       
Illeus  1/5 (20.00%)  1 0/11 (0.00%)  0 0/3 (0.00%)  0
General disorders       
Fall  2/5 (40.00%)  2 1/11 (9.09%)  1 0/3 (0.00%)  0
Infections and infestations       
Infection [1]  0/5 (0.00%)  0 1/11 (9.09%)  1 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Low Back Pain  1/5 (20.00%)  1 2/11 (18.18%)  2 0/3 (0.00%)  0
Spinal Stenosis  1/5 (20.00%)  1 0/11 (0.00%)  0 0/3 (0.00%)  0
[1]
Incision site infection
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
Layout table for Results Point of Contact information
Name/Title: Laura Herdrich
Organization: Zimmer
Phone: 952-830-6224
EMail: laura.herdrich@zimmer.com
Layout table for additonal information
Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00762723     History of Changes
Other Study ID Numbers: 2006-016
First Submitted: September 26, 2008
First Posted: September 30, 2008
Results First Submitted: February 10, 2014
Results First Posted: March 26, 2014
Last Update Posted: April 17, 2014