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Completed

NCT Number: NCT05993195

Re-operation Rates of Concorde Bullet Device Versus Conduit Titanium Interbody Graft for Lumbar Fusion

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.

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Key information

Conditions

Degenerative Spondylolisthesis Bone Diseases Lumbar Spondylolisthesis Lumbar Spondylosis Musculoskeletal Diseases Spinal Diseases Spondylolisthesis Spondylolysis Spondylosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conduit Titanium Interbody Graft

Device

The Concorde Bullet Device is compared with Conduit Titanium Interbody Graft for lumber fusion in terms of reoperation rates at 2 years.

Concorde Bullet Device

Device

This traditional device is to compare the clinical results of the new Conduit Titanium Interbody device for lumbar fusion

Primary outcomes

  1. Reoperation rate

    Time frame: 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 outcomes

  1. Surgical Variables of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion

    Time frame: 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 outcomes

  1. Baseline Demographics of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion

    Time frame: 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.

  2. EQ5D of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion

    Time frame: 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).

  3. ODI of Concorde Bullet Device versus Conduit Titanium Interbody Graft for lumber fusion

    Time frame: 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%.

Sponsors and collaborators

Lead sponsor

Lahey Clinic

Other

Collaborators

  • DePuy Synthes

Registry information

Official study title

Comparative Analysis of Re-operation Rates of Concorde Bullet Device Versus Conduit Titanium Interbody Graft for Lumbar Fusion

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Aug 15, 2023
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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