Degenerative Spondylolisthesis, Lumbar Spondylolisthesis, Lumbar Spondylosis
Conditions
Keywords
lumbar fusion
Brief summary
The purpose of this early study is to compare the clinical results of the new Conduit Interbody device to the traditional Concorde Bullet Device. The primary objective is to explore the rates and reasons for re-operation between both constructs at 2 years.
Detailed description
The demand for lumbar fusion continues to rise with the growing and aging population. Additionally, new and innovative technologies continue to bring new devices to the market. However, our understanding of how emerging constructs compare with existing technology is lacking. The purpose of this study is to compare the clinical results of the new Conduit Interbody device to the traditional Concorde Bullet Device in lumbar fusion, one or two levels between L2-S1 will be included. Both transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF) approaches will be included in the patient cohort. The primary objective is to explore the rates and reasons for re-operation between both constructs at 2 years.
Interventions
DEVICEConduit Titanium Interbody Graft
The Concorde Bullet Device is compared with Conduit Titanium Interbody Graft for lumber fusion in terms of reoperation rates at 2 years.
DEVICEConcorde Bullet Device
This traditional device is to compare the clinical results of the new Conduit Titanium Interbody device for lumbar fusion
Sponsors
DePuy Synthes
Lahey Clinic
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 or older with symptomatic degenerative lumbar spondylotic disease, either spondylosis, and/or spondylolisthesis * who have failed conservative management of at least 6 weeks requiring 1 or 2 level lumbar interbody fusion (either PLIF or TLIF) * All patients included will be index surgeries (no re-operations).
Exclusion criteria
* Patients who improve with consecutive management and do not undergo lumbar fusion surgery * Surgery performed in the thoracic or cervical spine * Surgery performed for tumor, infection, or trauma Patients who have an unstable fracture, tumor, and osteoporosis with T score exceeding -2.0
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reoperation rate | 1 year and at 2 years | a comparison of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumbar fusion in terms of reoperation rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Variables of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion | 2 years | Assessment of surgical variables, such as type of bone graft or bone graft extenders (including ViviGen, bone morphogenetic protein (BMP), tricalcium phosphate, local autograft, allograft, allograft chips, or demineralized bone matrix), on reoperations |
Other
| Measure | Time frame | Description |
|---|---|---|
| Baseline Demographics of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion | 1 year and 2 years | Demographics, comorbidities, will be assessed including efficacy, safety, and fusion rates. Demographics include the following: gender, age, race, BMI, weight (oz.), height (inches), ASA class, surgery level. Comorbidities include the following: diabetes, heart failure, coronary artery disease, anxiety/depression, active smoker, pre-operative opioid use. |
| EQ5D of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion | 1 year and 2 years | The EQ5D index scale is a 5-dimension standardized measurement of heath status developed by EuroQol. The EQ5D index is derived by applying a formula that consist of weights. It is calculated by assigning a numerical value to each response level (ie. 1 for no problem, 3 for extreme problem/unable to). The EQ5D scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health scale). |
| ODI of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion | 1 year and 2 years | The Oswestry Disability Index is a gold standard outcome measure that was designed to assess daily function for those who experience back pain. The questionnaire consists of 10 questions presented as a 6-Likert scale. For each section the total possible score is 5; the first statement marked would score=0; the last statement marked would score=5. Scores range from 0% to 100%. |
Countries
United States
Outcome results
None listed