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Completed

NCT Number: NCT02985138

Comparison of Unilateral or Bilateral Fixation in the Treatment of LFS

TLIF is a popular lumbar fusion technique to perform interbody fusion. Pedicle screws providing initial stability have been developed to correct deformity, improve the rate of fusion and speed patient's postoperative recovery. Conventionally, bilateral pedicle screw fixation is a standard approach. Recently, studies have revealed that unilateral pedicle screw fixation provides equivalent clinical outcomes and fusion rates as compared with bilateral pedicle screw fixation in lumbar fusion. Meanwhile, the unilateral approach can reduce intraoperative blood loss and operating time. To our knowledge, few randomized controlled studies comparing unilateral versus bilateral instrumented TLIF in lumbar degenerative diseases have been reported. The purpose of this study is to compare clinical and radiographic outcomes in a series of patients with lumbar foraminal stenosis using instrumented TLIF with unilateral or bilateral pedicle screw fixation.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthopedic Surgery, Shanghai Ninth People's Hospital

Shanghai, 200011, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed informed consent.
  • Patient is willing to be available for each examination scheduled over the study duration.
  • Lumbar foraminal stenosis diagnosed by patient history, physical examination and image confirmation.
  • Patient has symptoms referable to the stenosis level (low back pain, leg pain, tingling, numbness or weakness), which are relieved after a selective nerve root block.
  • Has not responded to conservative treatment for a period of 3 months (e.g. bed rest, physical therapy, medication, manipulations, other).

Exclusion criteria

  • Has systemic infection, highly communicable diseases, inflammatory or autoimmune disease (e.g. osteomyelitis, crohn's, rheumatoid arthritis, systemic lupus, gout, HIV/AIDS, active tuberculosis, venereal disease, active hepatitis).
  • Has presence of active malignancy
  • Has a history of severe allergy
  • Has a significant medical history that, in the investigator's opinion, would not make them a good study candidate.
  • Pregnant, or may become pregnant within follow-up period of study
  • Has other spinal conditions that will interfere with clinical outcomes (e.g. spinal structural deformities, spinal fractures, ankylosing spondylitis, spinal tuberculosis, spinal infection, spinal tumors, symptomatic cervical spinal disease)
  • Spondylolisthesis at the target level
  • Has undergone previous lumbar surgery
  • Has severe osteoporosis (T-score ≤ -3.5)
  • BMI > 35kg/m2
  • Has a diagnosis, which requires postoperative medication that interferes with fusion, such as steroids.
  • Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, Ehlers-Danios syndrome or osteogenesis imperfecta)

Treatment and study plan

TLIF and unilateral pedicle screw fixation

Procedure

TLIF combined with posterior unilateral pedicle screw fixation

TLIF and bilateral pedicle screw fixation

Procedure

TLIF combined with posterior bilateral pedicle screw fixation

Pedicle screw and cage

Device

Pedicle screw and cage

Primary outcomes

  1. Visual Analogue Scale (VAS) scores

    Time frame: 2 years postoperatively

Secondary outcomes

  1. Adverse events related to procedure

    Time frame: 2 years postoperatively

  2. Operative duration

    Time frame: 1 week postoperatively

  3. Estimated blood loss

    Time frame: 1 week postoperatively

  4. Length of hospital stay

    Time frame: 1 week after discharge

  5. Spinal angles

    Time frame: 2 years postoperatively

    Radiographic parameters

  6. Intervertebral space height

    Time frame: 2 years postoperatively

    Radiographic parameters

  7. Foraminal height

    Time frame: 2 years postoperatively

    Radiographic parameters

  8. Cost of treatment

    Time frame: 2 years postoperatively

  9. Fusion rate

    Time frame: 2 years postoperatively

  10. Oswestry Disability Index (ODI)

    Time frame: 2 years postoperatively

Sponsors and collaborators

Lead sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Other

Registry information

Official study title

Comparison of Unilateral or Bilateral Fixation Using Pedicle Screws and TLIF in the Treatment of Lumbar Foraminal Stenosis

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Dec 7, 2016
Registry last updated
Jan 25, 2022

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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