Patient Outcomes Using an Expandable Spacer
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03162666|
Recruitment Status : Not yet recruiting
First Posted : May 22, 2017
Last Update Posted : May 22, 2017
|Condition or disease||Intervention/treatment|
|Degenerative Disc Disease||Device: ALTERA|
The evaluation is based on the following elements.
- Safety as measured by the rate of serious operative and post-operative complications.
- Subjects quality of life, measured by health-related quality of life questionnaires and Subject-reported outcome measures up to 24 months following the procedure, as compared to Subject's preoperative baseline.
- Global and segmental lumbar lordosis (LL)
Patients will be followed upto 24 months post-operative
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Post-market Surveillance Study of Altera™ Minimally Invasive Articulating Expandable Spacer in a TLIF Interbody Fusion Device|
|Estimated Study Start Date :||May 25, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||February 28, 2020|
- Change in Radiographic Analysis [ Time Frame: Pre-Op, 6weeks, 12 weeks, 6months, 12 months, 24 months ]Global and Segmental Lumbar Lordosis in degrees
- Complications [ Time Frame: Intra-operative, any time post-op upto 24 months ]Surgical or device related complications
- Change in Patient Reported Outcomes as a number score [ Time Frame: Pre-Op, 6weeks, 12 weeks, 6months, 12 months, 24 months ]Visual Analog Scale, Oswestry Disability Index, Short Form 12, PROMIS
- Peri operative clinical parameters [ Time Frame: Intra-Operative ]Estimated Blood Loss in cc
- Clinical parameters in days [ Time Frame: Immediate Post-operative ]Length of Hospital Stay
- Peri operative clinical parameters in mgs [ Time Frame: Immediate Post-operative ]Narcotic Consumption
- Intra-Operative clinical parameters in minutes [ Time Frame: Intra-Operative ]Operative Time
- Changes in Radiographic Analysis in percentage [ Time Frame: 6weeks, 12 weeks, 6months, 12 months, 24 months ]Fusion Rates
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03162666
|Contact: Gita Joshua||610-930-1800 ext email@example.com|
|Contact: Susan Dvojack||312.942.6689||Susan_Dvojack@rush.edu|
|Principal Investigator:||Kern Singh, MD||Rush Univeristy Medical Center Orthopedic Surgeon|