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Trial record 55 of 12473 for:    cervical

Advent™ Cervical Disc Versus ACDF for Treatment of One Level Degenerative Disc Disease (IDE Study)

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: NCT00637312
Recruitment Status : Terminated (Greater-than-anticipated rate of revisions)
First Posted : March 17, 2008
Results First Posted : March 27, 2014
Last Update Posted : March 27, 2014
Sponsor:
Information provided by (Responsible Party):
Orthofix Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Cervical Degenerative Disc Disease
Interventions Device: Cervical Artificial Disc (Advent™ Cervical Disc)
Device: Hallmark™ Anterior Cervical Plate System
Enrollment 108
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Advent™ Cervical Disc Standard Care - Control
Hide Arm/Group Description Cervical artificial disc replacement: Advent™ Cervical Disc Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
Period Title: Overall Study
Started 72 36
Completed 30 19
Not Completed 42 17
Arm/Group Title Advent™ Cervical Disc Standard Care - Control Total
Hide Arm/Group Description Cervical artificial disc replacement: Advent™ Cervical Disc Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System Total of all reporting groups
Overall Number of Baseline Participants 72 36 108
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 36 participants 108 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
72
 100.0%
36
 100.0%
108
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants 36 participants 108 participants
43  (8.5) 45.6  (9.1) 43.9  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 36 participants 108 participants
Female
36
  50.0%
19
  52.8%
55
  50.9%
Male
36
  50.0%
17
  47.2%
53
  49.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 72 participants 36 participants 108 participants
72 36 108
1.Primary Outcome
Title Evaluation of Device and/or Procedure Related Adverse Event(s)
Hide Description [Not Specified]
Time Frame At 24-months
Hide Outcome Measure Data
Hide Analysis Population Description
The study was suspended for higher than anticipated adverse events in the treatment group. Enrollment was stopped and patients were followed for 36 months in the Advent treatment group. Agency approval is not being pursued for this device and thus no analysis has been completed.
Arm/Group Title Advent™ Cervical Disc Standard Care - Control
Hide Arm/Group Description:
Cervical artificial disc replacement: Advent™ Cervical Disc
Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were collected immediately post-op through the 24 month visit for control patients and through 36 months for treatment patients.
Adverse Event Reporting Description Adverse events were collected at all routine and unscheduled follow-up visits.
 
Arm/Group Title Advent™ Cervical Disc Standard Care - Control
Hide Arm/Group Description Cervical artificial disc replacement: Advent™ Cervical Disc Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
All-Cause Mortality
Advent™ Cervical Disc Standard Care - Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Advent™ Cervical Disc Standard Care - Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/72 (22.22%)      1/36 (2.78%)    
Surgical and medical procedures     
Medical device removal  1  16/72 (22.22%)  17 1/36 (2.78%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Advent™ Cervical Disc Standard Care - Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   58/72 (80.56%)      21/36 (58.33%)    
Blood and lymphatic system disorders     
Lymphadenopathy  1  0/72 (0.00%)  0 1/36 (2.78%)  1
Eye disorders     
Eyelid ptosis  1  0/72 (0.00%)  0 1/36 (2.78%)  1
General disorders     
Pain * 1  3/72 (4.17%)  3 1/36 (2.78%)  1
Infections and infestations     
Herpes zoster  1  2/72 (2.78%)  2 0/36 (0.00%)  0
Injury, poisoning and procedural complications     
Procedural complication * 1  0/72 (0.00%)  0 1/36 (2.78%)  1
Urinary retention postoperative  1  0/72 (0.00%)  0 1/36 (2.78%)  1
Metabolism and nutrition disorders     
Hypothyroidism  1  2/72 (2.78%)  2 0/36 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Neck Pain  1  26/72 (36.11%)  26 8/36 (22.22%)  8
Pain in extremity  1  20/72 (27.78%)  20 10/36 (27.78%)  10
Pseudoarthrosis  1  1/72 (1.39%)  1 4/36 (11.11%)  4
Back Pain  1  5/72 (6.94%)  5 5/36 (13.89%)  5
Exostosis  1  2/72 (2.78%)  2 0/36 (0.00%)  0
Spinal osteoarthritis  1  0/72 (0.00%)  0 2/36 (5.56%)  2
Intervertebral disc protrusion  1  3/72 (4.17%)  3 0/36 (0.00%)  0
Muscle Spasms  1  2/72 (2.78%)  2 0/36 (0.00%)  0
Musculoskeletal pain  1  6/72 (8.33%)  6 1/36 (2.78%)  1
Myalgia  1  2/72 (2.78%)  2 0/36 (0.00%)  0
Muscle strain  1  2/72 (2.78%)  2 0/36 (0.00%)  0
Bone pain  1  0/72 (0.00%)  0 1/36 (2.78%)  1
Bursitis  1  0/72 (0.00%)  0 1/36 (2.78%)  1
Intervertebral disc degeneration  1  0/72 (0.00%)  0 1/36 (2.78%)  1
Osteoarthritis  1  0/72 (0.00%)  0 1/36 (2.78%)  1
Spinal fracture  1  0/72 (0.00%)  0 1/36 (2.78%)  1
Tendonitis  1  0/72 (0.00%)  0 1/36 (2.78%)  1
Nervous system disorders     
Hypoaesthesia  1  12/72 (16.67%)  12 4/36 (11.11%)  4
Paraesthesia  1  5/72 (6.94%)  5 4/36 (11.11%)  4
Headache  1  9/72 (12.50%)  9 4/36 (11.11%)  4
Burning sensation  1  2/72 (2.78%)  2 0/36 (0.00%)  0
Muscular weakness  1  2/72 (2.78%)  2 1/36 (2.78%)  1
Nervous system disorder  1  2/72 (2.78%)  2 0/36 (0.00%)  0
Dysaesthesia  1  0/72 (0.00%)  0 2/36 (5.56%)  2
Hemiparesis  1  0/72 (0.00%)  0 1/36 (2.78%)  1
Restless legs syndrome  1  0/72 (0.00%)  0 1/36 (2.78%)  1
Psychiatric disorders     
Depression * 1  2/72 (2.78%)  2 0/36 (0.00%)  0
Anxiety postoperative  1  0/72 (0.00%)  0 1/36 (2.78%)  1
Respiratory, thoracic and mediastinal disorders     
Dysphonia  1  0/72 (0.00%)  0 1/36 (2.78%)  1
Skin and subcutaneous tissue disorders     
Dermatitis contact  1  0/72 (0.00%)  0 1/36 (2.78%)  1
Surgical and medical procedures     
Intervertebral disc operation  1  1/72 (1.39%)  1 1/36 (2.78%)  1
Vascular disorders     
Hypertension  1  0/72 (0.00%)  0 1/36 (2.78%)  1
Haematoma  1  0/72 (0.00%)  0 1/36 (2.78%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA15.1
The study was suspended for a high rate of adverse events in the treatment group. Enrollment was stopped and patients were followed for 36 months in the Advent group. Approval is not being pursued and thus no analysis has been completed.
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.
Within the first 12 months following completion of the study, any publication must be initiated as a multi-center publication in conjunction with other PIs in the study. After 12 months, each PI is able to publish their data, but must first submit the publication to the sponsor within 60 days prior to publication. The sponsor has the right to make reasonable requests to protect the rights and interests of the sponsor.
Results Point of Contact
Name/Title: Ruba Sarris
Organization: Orthofix
Phone: 214-937-2256
Responsible Party: Orthofix Inc.
ClinicalTrials.gov Identifier: NCT00637312     History of Changes
Other Study ID Numbers: CP-01003
First Submitted: March 10, 2008
First Posted: March 17, 2008
Results First Submitted: February 12, 2014
Results First Posted: March 27, 2014
Last Update Posted: March 27, 2014