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| Sponsor: | NuVasive |
|---|---|
| Information provided by: | NuVasive |
| ClinicalTrials.gov Identifier: | NCT00927238 |
Purpose
The purpose of this study is to evaluate the safety and effectiveness of XL TDR in patients with single-level degenerative disc disease compared to other devices approved by the FDA for the same or similar indications.
| Condition | Intervention | Phase |
|---|---|---|
|
Degenerative Disc Disease |
Device: XL TDR Other: Lumbar fusion surgery |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pivotal, Multi-Center, Clinical Trial Evaluating The Safety And Effectiveness of The Lumbar TDR Device In Patients With Single-Level Lumbar Degenerative Disc Disease |
| Estimated Enrollment: | 300 |
| Study Start Date: | July 2009 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
XL TDR: Experimental
The XL TDR is indicated for reconstruction of the disc following discectomy in skeletally mature subjects with symptomatic degenerative disc disease (DDD) of the lumbar spine at one level from L1-L5. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history radiographic studies.
|
Device: XL TDR
This will be a lateral approach discectomy and reconstruction with the insertion of the XL TDR device.
Other: Lumbar fusion surgery
Lumbar fusion surgery
|
| Outcomes from lumbar fusion study |
Other: Lumbar fusion surgery
Lumbar fusion surgery
|
The XL TDR® eXtreme Lateral Total Disc Replacement consists of two endplates that are provided in a number of sizes to accommodate a variety of patient anatomies and pathologies. The XL TDR device is made up of a ball and socket articulation and the joint is made of CoCrMo alloy.
The XL TDR is intended to be used to reconstruct the spine following the removal of part or all of the intervertebral disc on one level of the lumbar spine.
The XL TDR is indicated for reconstruction of the disc following discectomy in skeletally mature subjects with symptomatic degenerative disc disease (DDD) of the lumbar spine at one level from L1-L5. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history radiographic studies.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Silicon Valley Spine Institute | Recruiting |
| Campbell, California, United States, 95008 | |
| Contact: Amelia Panighetti 408-376-3311 amelia@svspine.com | |
| Principal Investigator: Jeffrey D Coe, MD | |
| UCSD Medical Center | Withdrawn |
| San Diego, California, United States, 92103 | |
| Conejo Spine | Recruiting |
| Thousand Oaks, California, United States, 91360 | |
| Contact: Erik Spayde, MD 805-379-2322 | |
| Principal Investigator: Erik Spayde, MD | |
| United States, Colorado | |
| Spine Colorado / Durango Orthopedic Associates | Recruiting |
| Durango, Colorado, United States, 81301 | |
| Contact: Katie Patty 970-375-3696 kpatty@spinecolorado.com | |
| Principal Investigator: Jim Youssef, MD | |
| United States, Delaware | |
| Christiana Spine Center | Recruiting |
| Newark, Delaware, United States, 19713 | |
| Contact: Natalie Knitowski 302-623-4161 nuvasivestudy@christianaspinecenter.com | |
| Principal Investigator: Rush Fisher, MD | |
| United States, District of Columbia | |
| Georgetown University Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Lucy Kim, CCRP 202-444-1183 ilk3@georgetown.edu | |
| Principal Investigator: Faheem Sandhu, MD | |
| United States, Florida | |
| South Florida Spine Institute | Recruiting |
| Miami Beach, Florida, United States, 33140 | |
| Contact: Melissa Seits, PA-C 305-532-2411 mseits@southfloridaspine.com | |
| Principal Investigator: Jonathan Hyde, MD | |
| Southeastern Spine Center & Research Institute | Recruiting |
| Sarasota, Florida, United States, 34342 | |
| Contact: Debbie Sobering 941-371-9773 ext 106 | |
| Principal Investigator: Thomas M Sweeney, MD | |
| University of South Florida | Recruiting |
| Tampa, Florida, United States, 33606 | |
| Contact: Debbie Scott, BA, CCRC 888-674-2326 xlmotion@nuvasive.com | |
| Principal Investigator: Juan Uribe, MD | |
| United States, Georgia | |
| West Augusta Spine Specialists | Recruiting |
| Augusta, Georgia, United States, 30909 | |
| Contact: Carolina Poteet 706-922-4450 bcp@knology.net | |
| Contact: James Polhill 706-724-9607 | |
| Principal Investigator: IIdemaro Volcan, MD | |
| Sub-Investigator: Alan Goodrich, MD | |
| Sub-Investigator: Gregory Oetting, MD | |
| United States, Louisiana | |
| Spine Institute of Louisiana | Recruiting |
| Shreveport, Louisiana, United States, 71101 | |
| Contact: Ajay Jawahar, MD 318-629-5555 ajawahar@louisianaspine.org | |
| Principal Investigator: Pierce Nunley, MD | |
| United States, Missouri | |
| Spine Midwest | Recruiting |
| Jefferson City, Missouri, United States, 65101 | |
| Contact: Jamie Patterson 573-636-9000 jamie@spinemidwest.com | |
| Principal Investigator: Blake Rodgers, MD | |
| United States, Nevada | |
| Western Regional Spine Center for Brain and Spine Surgery | Recruiting |
| Las Vegas, Nevada, United States, 89109 | |
| Contact: Kyle Malone 702-851-0877 Kmalone@NNRF.net | |
| Contact: Ginger Christian 702-851-0877 gchristian@brainandspineonline.com | |
| Principal Investigator: William Smith, MD | |
| United States, New York | |
| Buffalo Spine Surgery | Recruiting |
| Lockport, New York, United States, 14094 | |
| Contact: Sarah Martineck 716-438-2973 diskstudy1@aol.com | |
| Contact: Faizah Shah 716-438-2973 diskstudy1@aol.com | |
| Principal Investigator: Andy Cappuccino, MD | |
| United States, Oregon | |
| Southern Oregon Orthopedics | Recruiting |
| Medford, Oregon, United States, 97504 | |
| Contact: Moni Peterson 541-608-2574 monip@oregonortho.com | |
| Principal Investigator: Mark Peterson, MD | |
| United States, South Carolina | |
| Southeastern Spine Institute | Recruiting |
| Mt. Pleasant, South Carolina, United States, 29464 | |
| Contact: Al Matus 843-849-1551 ext 138 al.matus@southeasternspine.com | |
| Principal Investigator: Donald Johnson, MD | |
| Sub-Investigator: Steven Poletti, MD | |
| United States, Texas | |
| Central Texas Spine Institute | Recruiting |
| Austin, Texas, United States, 78731 | |
| Contact: Amy Sasser 512-374-0677 asasser@pqrinc.com | |
| Contact: Celeste Figg 512-795-2225 cfigg@pqrinc.com | |
| Principal Investigator: Randall Dryer, MD | |
| United States, Washington | |
| Swedish Spine Institute | Recruiting |
| Seattle, Washington, United States, 98122 | |
| Contact: Megan Alexander 206-320-4355 Megan.Alexander@swedish.org | |
| Principal Investigator: Paul Schwaegler, MD | |
| Northwest Orthopaedic Specialists | Recruiting |
| Spokane, Washington, United States, 99208 | |
| Contact: Mirna Tohmeh 509-465-1300 Tohmeh@comcast.net | |
| Principal Investigator: Antoine Tohmeh, MD | |
| Sub-Investigator: Melvin Wahl, MD | |
| Sub-Investigator: Matthew Fewel, MD | |
| Principal Investigator: | William D Smith, MD | Western Regional Center for Brain and Spine Surgery |
More Information
| Responsible Party: | Clinical Affairs Manager ( Julie Pairamore ) |
| ClinicalTrials.gov Identifier: | NCT00927238 History of Changes |
| Other Study ID Numbers: | NUVA-LTDR-0701 |
| Study First Received: | June 22, 2009 |
| Last Updated: | July 29, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Single Level Lumbar Disc Disease DDD |
|
Spinal Diseases Bone Diseases Musculoskeletal Diseases |
