Trial Outcomes & Findings for Clinical Outcomes of the Trinica(R) Anterior Lumbar Plate: Fixed Screws vs. Variable Screws (NCT NCT00762723)

NCT ID: NCT00762723

Last Updated: 2014-04-17

Results Overview

\- Fusion Assessment

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 19 participants
• Primary outcome timeframe: Pre-operative, Operative; Follow-ups at 3 Months, 6 Months, 12 Months, and 24 Months
• Results posted on: 2014-04-17

Participant Flow

Participant milestones

Measure	ALP With Fixed Screws 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.	ALP With Variable Screws 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.	ALP With Hybrid Screws 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 Study STARTED	5	11	3
Overall Study COMPLETED	0	6	0
Overall Study NOT COMPLETED	5	5	3

Reasons for withdrawal

Measure	ALP With Fixed Screws 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.	ALP With Variable Screws 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.	ALP With Hybrid Screws 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 Study Study Terminated slow enrollement	5	5	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Group 1 n=5 Participants 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.	Group 2 n=11 Participants 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.	Group 3 n=3 Participants 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 n=19 Participants Total of all reporting groups
Age, Continuous	54 Years n=5 Participants	51 Years n=7 Participants	45 Years n=5 Participants	51 Years n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	11 Participants n=4 Participants

PRIMARY outcome

Timeframe: Pre-operative, Operative; Follow-ups at 3 Months, 6 Months, 12 Months, and 24 Months

Population: Data not analyzed because study was stopped due to slow enrollment.

• Fusion Assessment

Outcome measures

Outcome data not reported

Adverse Events

Group 1

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Group 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1 n=5 participants at risk 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.	Group 2 n=11 participants at risk 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.	Group 3 n=3 participants at risk 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.
Musculoskeletal and connective tissue disorders Cervical Disc Disease	20.0% 1/5	0.00% 0/11	0.00% 0/3

Other adverse events

Measure	Group 1 n=5 participants at risk 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.	Group 2 n=11 participants at risk 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.	Group 3 n=3 participants at risk 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.
Gastrointestinal disorders Illeus	20.0% 1/5 • Number of events 1	0.00% 0/11	0.00% 0/3
General disorders Fall	40.0% 2/5 • Number of events 2	9.1% 1/11 • Number of events 1	0.00% 0/3
Musculoskeletal and connective tissue disorders Low Back Pain	20.0% 1/5 • Number of events 1	18.2% 2/11 • Number of events 2	0.00% 0/3
Musculoskeletal and connective tissue disorders Spinal Stenosis	20.0% 1/5 • Number of events 1	0.00% 0/11	0.00% 0/3
Infections and infestations Infection	0.00% 0/5	9.1% 1/11 • Number of events 1	0.00% 0/3

Additional Information

Laura Herdrich

Zimmer

Phone: 952-830-6224

Email: laura.herdrich@zimmer.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place