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NCT Number: NCT02485574

Anterior Bridging Cage With Bone Substitute Versus Localized Autobone in Transforaminal Lumbar Interbody Arthrodesis

The purpose of this study is to evaluation for the pattern of bone bridging of patients who undergo transforaminal lumbar interbody arthrodesis, the investigators hypothesize that auto local bone mixed with β-calcium phosphate + hydroxyapatite (OSTEON 2, Genoss) is not inferior to auto local bone only. In addition, the investigators will analyze anterior new bone bridging pattern between anterior bridging cage newly developed and grafted bone in anterior disc space.

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Key information

Conditions

Stenosis Ankylosis Constriction, Pathologic Disease Fusion of Spine (Disease) Joint Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kwang Sup Song

Seoul, South Korea

About this study

A single center, observational, single arm study to evaluate the efficacy of auto local bone mixed with β-calcium phosphate + hydroxyapatite using interbody fusion assessment on multi-axial CT scan. Its active comparator is auto local bone.

Anterior bridging bone between anterior grafted bone and inserted cage will be assessed by using newly developed anterior bridging cage as well as interbody bone bridging between two vertebral bodies on multi-axial reconstructed CT scan.

The patients undergoes arthrodesis surgery will have two cages, one augmented with auto local bone will be located at left side of disc space and the other cage augmented with auto local bone mixed with β-calcium phosphate + hydroxyapatite at right side of disc space.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients who need lumbar interbody fusion in Degenerative spine disease on L1-S1(Spinal stenosis, HIVD and internal derangement of disk, spine instability)
  • Patients who have no communication problems
  • Patients who are willing to visit the hospital for any follow-up assessment
  • Patients who voluntarily sign on a written consent

Exclusion criteria

  • Patients who have infection
  • Patients who have bleeding disorders
  • Patients who have immunosuppressed disease
  • Patients who can't sign on consent form
  • Patients who are in pregnancy or breast feeding
  • Patients who have severe osteoporosis
  • Patients who can't take general surgery because of severe liver disease or decreased renal function
  • Patients who have acute spinal injury, spinal tumor or inflammatory spinal disease

Treatment and study plan

transforaminal lumbar interbody arthrodesis

Procedure

Anterior bridging cages augmented with auto bone plus β-calcium phosphate + hydroxyapatite in right side of disc space and anterior bridging cages augmented with auto bone in left side of disc space in transforaminal lumbar interbody arthrodesis.

Other names: β-calcium phosphate + hydroxyapatite (OSTEON 2, Genoss), Auto-local bone

Primary outcomes

  1. InCBB of Both Cages

    Time frame: 12 month postoperatively

    We used the concept of InCBB (intra-cage bridging bone) to evaluate the fusion status. InCBB was defined as the bridging bone between the upper and lower vertebrae through the void of the cage(s) and divided into right (Rt.) and left (Lt.) InCBB according to the cage position. We graded bridging scores from 0 to 2 based on the degree of completion of the bridging bone in InCBBs (grade 0: no bridging at the superior and inferior endplates; grade 1: incomplete bridging; bridging at the superior or inferior endplate, but with a clear radiolucent line; grade 2: complete bridging).

Secondary outcomes

  1. ABB (Anterior Bone Bridging) Between Cage and Anterior Grafted Bone

    Time frame: 12 month postoperatively

    We defined ABB as the bridging bone between the extra-cage grafted bone and intra-cage grafted bone through the holes in each cage. Since the cages used in this study each have 4 anterior holes, there can be a minimum of 0 and a maximum of 8 ABBs in a patient.

Other outcomes

  1. ODI Change (Preoperative ODI Score - Postoperative 1 Year ODI Score)

    Time frame: postoperative 1 year

    The Oswestry Disability Index (ODI) is an index used by clinicians and researchers to quantify disability for low back pain.

    The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.

Sponsors and collaborators

Lead sponsor

Zenoss Co, Ltd

Other

Registry information

Official study title

Prospective, Observational Study of Anterior Bridging Cage Augmented With Bone Substitute Versus Localized Autobone in Transforaminal Lumbar Interbody Arthrodesis

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jun 30, 2015
Registry last updated
Dec 8, 2021

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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