- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03344484
Midline Versus Paramedian Approaches in Treating Degenerative Lumbar Spondylolisthesis
A Pilot Study Comparing Midline Versus Paramedian Approaches to the Lumbar Spine for Single- or Two-Level Fusions in Degenerative Spondylolisthesis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Paramedian lumbar interbody fusion has been hypothesized to be advantageous over midline approaches for several reasons, the most important of which is lower post-operative infection rates. To achieve our long-term goal of conducting a RCT to examine this issue in-depth, a pilot study is initially required to examine if this surgical approach may indeed lower infection rates and associated health care cost savings.
It is hypothesized that: (1) there will be a statistically- and clinically-significant difference in infection rates with each approach to the lumbar spine, with those for the paramedian approach being lower; and (2) as a result of lower infection and complication rates, and reduced length of stay, the costs associated with the paramedian approach to the spine will be substantially less.
All consecutive patients deemed appropriate surgical candidates with single or two-level degenerative spondylolisthesis will be approached for participation and inclusion/exclusion criteria will be evaluated. (Note: Target enrollments will not be set a priori, but determined through the course of this proposal.) Once patients are confirmed to be eligible for the study, baseline patient reported outcome data will be collected (ODI, SF-12, EQ-5D, PHQ-9 and generic demographic information). Recruits will be randomized into either the midline or paramedian group using a computer-generated randomization process. After surgery, the surgeon will complete a post-operative summary, discharge form and adverse events form. Follow-up appointments at 6 weeks and 3 months will include repeating the patient reported health outcome questionnaires (ODI, SF-12, EQ-5D, PHQ-D) as well as a cost diary and pain questionnaire. With the assistance of our institution's Research Methods Unit, data analysis will be conducted. Continuous variables (length of stay, SF-12, EQ-5D) will be compared using students T-test while adjusting for potential confounders (diabetes, primary diagnosis, etc) using multi regression models. Categorical data will be analyzed using Chi-squared analysis while controlling for confounders using Cox-proportional hazards ratios.
One of the primary outcomes will be infection rates. To avoid bias in this area, infection will be tracked using the Center for Disease Control (CDC) criteria for diagnosing both deep and superficial infections. Deep infections will be diagnosed with deep wound cultures. The CDC criteria for diagnosing superficial infection is erythema, drainage, dehiscence and "surgeon opinion", allowing for significant subjectively in superficial infections. As such, it is possible that surgeons may preferentially diagnose more midline or Wiltse incisions with superficial infection depending on whether they may have an inherent favoured approach. While it is impossible to truly blind surgeons, allied health care personnel who would have less bias in favour of one approach will assess all wounds. This is in-line with current practice, as wounds are generally assessed by nurses in the clinic, and staples or sutures are removed at the two-week follow-up visit. Surgeons are only asked to assess wounds that are questionable. This would decrease some of the potential bias as part of this un-blinded study. Surgeon opinion will have no impact on deep infection, because this will generally require irrigation and debridement in the operating theater which will be captured.
The benefits, in the event of a positive study outcome, will lead to substantial improvements in patient care with reduced infection rates. If the evidence is compelling from a pilot study, the goal would be to move to a prospective, multi-centered randomized control trial to further examine this research question and potential adoption of more midline sparing surgery for fusion procedures of the lumbar spine. In the event that significant cost savings are demonstrated, quality assurance officers and policy makers would be compelled to adjust remuneration codes and possibly limit the compensation in cases where a midline approach was chosen. The cost savings for the system would be substantial even if only a significant difference in infection rate was demonstrated. There are risks are for lumbar spine surgery in general. At present, these risks are assumed to be equivalent with the two surgical approaches to be examined in this study and patients joining in the study can be assured of high-quality care for their condition regardless of the treatment arm to which they are allocated. However, if this proposed study can show that infection rates can be lowered with surgical approach, then the benefits definitely outweigh the risks.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1) surgical candidates with single or two level degenerative spondylolisthesis with the following clinical findings:
- a clinical history of back, buttock and leg pain with walking or standing that is improved when lying, sitting or bending forward
- a clinical history of leg symptoms that are greater than or equal to back symptoms with walking or standing
- greater than 6 months of symptoms with failed conservative care
- 2) sufficiently fluent in English to provide informed consent and complete questionnaires with or without the need of an interpreter.
Exclusion Criteria:
- 1) clinical history of osteoporotic fracture or chronic oral steroid use;
- 2) previous posterior lumbar spinal surgery (excluding prior microdiscectomy); and
- 3) patients who have evidence of neurological disorders that affect physical function (e.g. peripheral neuropathy), neuromuscular disorders (e.g. multiple sclerosis, Parkinson's etc.) or systemic illness (e.g. inflammatory arthritis) that affects physical function
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Midline Approach
A midline surgical approach will be used for the exposure required to complete the lumbar fusion.
|
Comparison of 2 surgical approaches used to treat degenerative spondylolisthesis via one- and two-level fusion
|
Experimental: Paramedian Approach
A paramedian (i.e.
Wiltse) surgical approach will be used for the exposure required to complete the lumbar fusion.
|
Comparison of 2 surgical approaches used to treat degenerative spondylolisthesis via one- and two-level fusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infection rate
Time Frame: 6 months
|
infection will be tracked using the Center for Disease Control (CDC) criteria for diagnosing both deep and superficial infections.
Deep infections will be diagnosed with deep wound cultures.
The CDC criteria for diagnosing superficial infection is erythema, drainage, dehiscence and "surgeon opinion", allowing for significant subjectively in superficial infections.
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB1022987
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spondylolisthesis, Lumbar Region
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingSpondylolisthesis, Lumbar RegionFrance
-
The Methodist Hospital Research InstituteUnknownDegenerative Disc Disease | Spondylolisthesis, Lumbar Region
-
Fondazione Policlinico Universitario Agostino Gemelli...CompletedPostoperative Pain | Spinal Fusion | Spondylolisthesis, Lumbar Region | SufentanilItaly
-
Assuta Medical CenterUnknownSpinal Stenosis Lumbar | Spondylolisthesis | Degeneration Spine | Fusion of Spine, Lumbar RegionIsrael
-
7D Surgical Inc.Hospital for Special Surgery, New YorkCompletedSpondylolisthesis | Spinal Stenosis, Lumbar RegionUnited States
-
Ilse van de WijgertRadboud University Medical CenterRecruitingLumbar Disc Herniation | Lumbar Spinal Stenosis | Fusion of Spine | Spinal Fusion | Lumbar Spondylolisthesis | Spondylolisthesis | Lumbar Disc Disease | Lumbar Spondylosis | Lumbar Spine Disease | Lumbar Radiculitis | Spondylosis Lumbosacral RegionNetherlands
-
Bezmialem Vakif UniversityUnknownLumbar Disc Herniation | Lumbar Spinal Stenosis | Lumbar Spondylolisthesis | Scoliosis Lumbar Region | Lumbar Disc Lesion
-
Lahey ClinicDePuy SynthesActive, not recruitingLumbar Spondylolisthesis | Lumbar Spondylosis | Degenerative SpondylolisthesisUnited States
-
Kim Ki OkMayo Clinic; Korea Health Industry Development Institute; Kyunghee University...UnknownSpondylolisthesis, Lumbosacral RegionUnited States, Korea, Republic of
-
Methodist Health SystemActive, not recruitingLumbar Spondylolisthesis | Lumbar Spine DegenerationUnited States
Clinical Trials on Surgical approach
-
Cambridge University Hospitals NHS Foundation TrustEnrolling by invitation
-
Medacta USAMedacta International SACompletedOsteoarthritisUnited States
-
Seoul National University Bundang HospitalCompletedArthroplasty, Replacement, HipKorea, Republic of
-
University of Kansas Medical CenterNot yet recruitingLower Urinary Tract Symptoms | Benign Prostatic Hyperplasia
-
Technische Universität DresdenStryker InstrumentsCompleted
-
Ottawa Hospital Research InstituteNot yet recruiting
-
Sun Yat-sen UniversityActive, not recruitingLaparoscopic Surgery | Rectal Neoplasms | Neoplastic Cells, Circulating | Transanal Endoscopic SurgeryChina
-
JointResearchCompletedHemiarthroplasty | Hip Fractures | Surgical Approach | Posterolateral | Direct LateralNetherlands
-
University of AlbertaCanadian Association of Emergency PhysiciansCompleted
-
Batman Training and Research HospitalCompleted