C-Tek™ Fusion Study
This study has been terminated.
(Due to lack of follow-up information)
Sponsor:
EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
Information provided by (Responsible Party):
Biomet, Inc. ( EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing )
ClinicalTrials.gov Identifier:
NCT00585923
First received: December 21, 2007
Last updated: May 1, 2012
Last verified: May 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Results First Received: November 11, 2009
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single Blind (Subject); Primary Purpose: Treatment |
| Conditions: |
Herniated Disc Radiculopathy Spondylolysis |
| Intervention: |
Device: C-Tek™ Plate |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Recruitment was done through the population of Dr. Nunley's practice. Once Dr. Nunley decided that the patient was a candidate for cervical fusion, he discussed the study with the patient. After subject signed the informed consent subject was randomized to the Slotted Hole or the Fixed Hole C Tek™ Anterior Cervical Plate. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| Patients were included in this study if the answer to all of the inclusion criteria was yes and the answer to all of the exclusion questions was no. |
Reporting Groups
| Description | |
|---|---|
| Fixed Hole C-Tek Plate | Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF) |
| Slotted Hole C-Tek Plate | Slotted Hole C-Tek Plate for ACDF |
Participant Flow: Overall Study
| Fixed Hole C-Tek Plate | Slotted Hole C-Tek Plate | |
|---|---|---|
| STARTED | 56 | 59 |
| COMPLETED | 25 | 26 |
| NOT COMPLETED | 31 | 33 |
| Physician decided not to continue | 31 | 33 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Fixed Hole C-Tek Plate | Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF) |
| Slotted Hole C-Tek Plate | Slotted Hole C-Tek Plate for ACDF |
| Total | Total of all reporting groups |
Baseline Measures
| Fixed Hole C-Tek Plate | Slotted Hole C-Tek Plate | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
56 | 59 | 115 |
|
Age
[1] [units: participants] |
|||
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 46 | 50 | 96 |
| >=65 years | 5 | 7 | 12 |
|
Age
[units: years] Mean ± Standard Deviation |
49.46 ± 10.26 | 50.03 ± 10.04 | 49.76 ± 10.10 |
|
Gender
[units: participants] |
|||
| Female | 32 | 34 | 66 |
| Male | 24 | 25 | 49 |
| [1] | There were 5 patients in the fixed hole group and 2 patients in the slotted hole group who do not have calculated age due to missing information that we were unable to obtain from the clinical site |
|---|
Outcome Measures
| 1. Primary: | Fusion Success [ Time Frame: Last Follow-Up (Last follow-up ranged from no visit after surgery to 24 months of follow-up) ] |
| 2. Secondary: | Pain at Rest [ Time Frame: Baseline and Last Follow-Up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up) ] |
| 3. Secondary: | Pain With Activity [ Time Frame: Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up) ] |
| 4. Secondary: | Neurological Status Change in Neurological Status Since Surgery. [ Time Frame: Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up) ] |
| 5. Secondary: | Level of Function (Neck Disability Index) [ Time Frame: Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up) ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| 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. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| Early termination of this study because the doctor involved in the study decided that he did not want to participate in the study any more. The site also did not have very good follow-up on all of their patients |
Results Point of Contact:
Name/Title: Jacquelyn Hughes
Organization: Biomet
phone: 973-299-9300 ext 3075
e-mail: jacquelyn.hughes@biomet.com
Organization: Biomet
phone: 973-299-9300 ext 3075
e-mail: jacquelyn.hughes@biomet.com
No publications provided
| Responsible Party: | Biomet, Inc. ( EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing ) |
| ClinicalTrials.gov Identifier: | NCT00585923 History of Changes |
| Other Study ID Numbers: | CS-014 |
| Study First Received: | December 21, 2007 |
| Results First Received: | November 11, 2009 |
| Last Updated: | May 1, 2012 |
| Health Authority: | United States: Institutional Review Board |