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Vertebral Column Resection (VCR) in Congenital Kyphoscoliosis (CKS)

Primary Purpose

Congenital Spinal Deformity, Congenital Kyphoscoliosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Posterior Vertebral Column Resection (PVCR)
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Spinal Deformity focused on measuring Vertebral Column Resection, Congenital Spinal Deformity, Congenital Thoracolumbar Kyphoscoliosis

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Neglected congenital kyphoscoliotic spinal deformity
  • Thoracic and Lumbar curves only
  • Age more than 10 years old

Exclusion Criteria:

  • Cervical and Sacral deformities
  • Revision failed back surgeries

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Congenital Thoracolumbar Kyphoscoliosis

    Arm Description

    Correction of Adolescent Thoracolumbar Congenital Kyphoscoliosis (CKS) Spinal Deformity by Posterior Vertebral Column Resection (PVCR) Surgical Technique

    Outcomes

    Primary Outcome Measures

    Change in Scoliosis Research Society (SRS)-24 (arabic version) Health-related quality of life questionnaire
    The score of questionnaire components is used to assess how patients are doing regarding their function (day to day activities), their pain level (or hopefully improvement in/lack of), how they feel they look, how they feel about themselves, and if they are satisfied as the result of their treatment. Preoperative and postoperative scores are compared.

    Secondary Outcome Measures

    Oswestry Disability Index (ODI)
    Is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.
    Short Form (SF)-36 Health Survey
    Is widely validated and popularly used in assessing the subjective quality of life (QOL) of patients and the general public.
    Complications Rate
    As neurological deficit, vascular injury, deep infection, visual affection, pulmonary embolism, pleural effusion, deep venous thrombosis, implant-related problems, proximal junctional kyphosis, and re-operation for any cause.
    American Spinal Injury Association (ASIA) Score
    A score developed by the American Spinal Injury Association for essential minimal elements of neurologic assessment for all patients with a spinal injury.
    Local Kyphosis Angle (LKA)
    Assessed on the lateral radiograph by measuring the angle obtained by a line parallel to the inferior endplate of the deformed vertebra and that of the vertebra one level above.
    Lumbar Lordosis Angle (LLA)
    Angle measured between L1 and L5 lower end plates.
    Thoracic Kyphosis Angle (TKA)
    Angle measured between T1 and T12 lower end plates.
    Sagittal Vertical Axis (SVA) to C7 Plumb Line (C7PL)
    To quantify global alignment. It is defined as the sagittal offset of a plumb line dropped from the C7 vertebral body from the posterosuperior corner of the sacral plate.
    Scoliosis Angle (Cobb's Angle)
    To measure and quantify the magnitude of spinal deformities, especially in the case of scoliosis. The Cobb angle measurement is the "gold standard" of scoliosis evaluation endorsed by Scoliosis Research Society. It is used as the standard measurement to quantify and track the progression of scoliosis.
    Shoulder Balance (Clavicle Angle)
    It is the angle that is subtended between a horizontal reference line - clavicle horizontal reference line (CHRL), which is drawn perpendicular to the lateral edge of the radiograph and touches the most cephalad portion of the elevated clavicle and a line which touches the most cephalad aspect of both the right and left clavicles - clavicle reference line (CRL). By convention, angles subtended with the left shoulder up are positive and angles subtended with the right shoulder up are negative (consistent with directionality of the T1 tilt angle).
    Central Sacral Vertical Line (CSVL) to C7 Plumb Line (C7PL)
    Coronal decompensation is measured as the horizontal distance between a plumb line dropped downward from the center of the C7 (C7PL) vertebral body and the central sacral vertical line (CSVL), which is a line drawn vertically through the center of the sacrum.
    Body Height (BH)
    The height is measured using a measuring tape with patient standing without shoes.
    T1-S1 Trunk Height (TH)
    The T1-S1 height of the spine and the T1-S1 length of the spine are measured and compared.
    Leg Length Discrepancy (LLD)
    Radiographic measurement of difference between the lengths of the legs. Full-length standing anteroposterior radiograph compared with scanogram.
    CT-based Classification for assessment of biological graft fusion
    A new assessment method of bony union using high-speed spiral CT imaging is proposed which reflects the gradually increasing biological stability of the construct. Grade I (complete fusion) implies cortical union of the allograft and central trabecular continuity. Grade II (partial fusion) implies cortical union of the structural allograft with partial trabecular incorporation. Grade III (unipolar pseudarthrosis) denotes superior or inferior cortical non-union of the central allograft with partial trabecular discontinuity centrally and Grade IV (bipolar pseudarthrosis) suggests both superior and inferior cortical non-union with a complete lack of central trabecular continuity.

    Full Information

    First Posted
    April 26, 2018
    Last Updated
    May 17, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03524027
    Brief Title
    Vertebral Column Resection (VCR) in Congenital Kyphoscoliosis (CKS)
    Official Title
    Posterior Vertebral Column Resection (PVCR) for Correction of Adolescent Thoracolumbar Congenital Kyphoscoliosis (CKS)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2018 (Anticipated)
    Primary Completion Date
    May 2019 (Anticipated)
    Study Completion Date
    May 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Congenital spinal deformities (CSD) are caused by early embryologic errors in vertebral column formation. Spinal cord malformations are present in approximately one third of patients, even associated cardiac, renal, and genitourinary organ system anomalies in more than half of patients. Functional activity and health-related quality of life (HRQOL) are severely affected in adolescents with neglected severe congenital kyphoscoliosis (CKS) progressive curves in developing countries. Different strategies are described with two main principles; I- Prophylactic surgeries like hemi-epiphysiodesis or in situ fusions that will cease worsening or allow progressive correction over time, II- Corrective surgeries like reconstructive osteotomies and spinal fusion with or without spinal resection. The perfect show in management of congenital spinal deformities is to pick up the curves at early stages where a prophylactic treatment can be achieved with minimal risk to the spinal cord, but certainly many cases are quite aggressive or come late enough where corrective surgeries and even spinal column resection is the only valid plan. A posterior-based vertebral column resection (VCR) is considered to be the preferred approach in the treatment of rigid, severe, and complex spinal deformities, however the difficult and lengthy nature of the procedure require assistance from experienced and well trained team. It is relatively safe but challenging technique, that allows for dramatic radiographic correction and clinical improvement. It also carries a complication rate of 10.2% as profound blood loss, iatrogenic neurological deficit and late junctional kyphosis.
    Detailed Description
    Preoperative Details : Every patient is examined for 1- Shoulder balance 2- Pelvic balance 3- Thoracic hump 4- Neurological examination. Also preoperative whole-spine X-ray anteroposterior and lateral view radiographs in erect position are obtained for accurate preoperative planning. Three-dimensional Multi-Slice Computed Tomography (MSCT) scan is obtained to delineate posterior vertebral column pathoanatomy before surgery. Whole-spine MRI is obtained for declaration of any associated spinal cord malformation. Operative Details : Appropriate patient positioning on the operating frame to avoid excessive pressure points in the axilla, allow the abdomen to hang free, and to maintain stability of the trunk during surgery. Standard posterior exposure is performed, and pedicle screws are placed using a free-hand technique as. The exposure at the osteotomy site is extended laterally to resect a portion of the medial ribs to enhance the exposure of the vertebral body to be removed. Once adequate exposure is achieved, a wide laminectomy is completed from the pedicles of the proximal vertebra to the pedicles of the distal vertebra. Use of tranexamic acid to minimize osseous bleeding during these lengthy surgeries is advisable. At this point, a short rod is placed into the pedicle screws of 1 side to include at least 2 pedicle screws proximally and 2 pedicle screws distally, to provide stability during the osteotomy. Once this rod is secured, the proximal and distal discs are removed and the vertebra to be removed is outlined. Then, the osteotomy is started from the pedicle on the contralateral side, and extending into the body. The exiting nerve roots are tied and transected at the thoracic levels, gently retracted at the lumbar levels. The removal of vertebral body is proceeded using Kerrison rongeurs and osteotomes as necessary. After adequate removal, another rod is placed to the already osteotomized side, and secured. At this point the rod on the other side can be removed or kept in place, depending on the amount of expected instability. The resection carried similarly on the contralateral side. The posterior wall of the vertebral body is kept intact until the very end of the osteotomy. After the removal of the vertebral body and discs, using a reverse cutting curette the posterior wall is fractured with anteriorly directed blows and removed using rongeurs. The endplates of the neighboring vertebrae are cleaned off of any remaining cartilage to expose bone surfaces to achieve fusion. The anterior defect is augmented with morsellized cancellous graft with or without the use of a titanium mesh cage, depending on the width of the void. After the completion of resection, deformity correction is carried out and the posterior instrumentation system is secured using pedicle screws. Application of Wakeup test to detect any on-table neurology. Decortication followed by addition of remaining autograft and allograft to the fusion is performed. Posterior wound closure is performed over a drain. Postoperative Details : Follow-up protocol is carried out after 2 weeks, 3 months, 1 year, and 2 years postoperatively with whole-spine X-Ray radiographs in erect position, and after 1 year with Multi-Slice Computed Tomography (MSCT) scan to assess fusion rate.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Congenital Spinal Deformity, Congenital Kyphoscoliosis
    Keywords
    Vertebral Column Resection, Congenital Spinal Deformity, Congenital Thoracolumbar Kyphoscoliosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Congenital Thoracolumbar Kyphoscoliosis
    Arm Type
    Experimental
    Arm Description
    Correction of Adolescent Thoracolumbar Congenital Kyphoscoliosis (CKS) Spinal Deformity by Posterior Vertebral Column Resection (PVCR) Surgical Technique
    Intervention Type
    Procedure
    Intervention Name(s)
    Posterior Vertebral Column Resection (PVCR)
    Other Intervention Name(s)
    Vertebrectomy, Corpectomy, Spondylectomy, VCR
    Intervention Description
    Posterior Vertebral Column Resection (PVCR) Surgical Technique for Correction of Adolescent Thoracolumbar Congenital Kyphoscoliosis (CKS) Spinal Deformity
    Primary Outcome Measure Information:
    Title
    Change in Scoliosis Research Society (SRS)-24 (arabic version) Health-related quality of life questionnaire
    Description
    The score of questionnaire components is used to assess how patients are doing regarding their function (day to day activities), their pain level (or hopefully improvement in/lack of), how they feel they look, how they feel about themselves, and if they are satisfied as the result of their treatment. Preoperative and postoperative scores are compared.
    Time Frame
    Baseline preoperative, then 3 months, and 1 year postoperative
    Secondary Outcome Measure Information:
    Title
    Oswestry Disability Index (ODI)
    Description
    Is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.
    Time Frame
    Baseline preoperative, then 3 months, and 1 year postoperative
    Title
    Short Form (SF)-36 Health Survey
    Description
    Is widely validated and popularly used in assessing the subjective quality of life (QOL) of patients and the general public.
    Time Frame
    Baseline preoperative, then 3 months, and 1 year postoperative
    Title
    Complications Rate
    Description
    As neurological deficit, vascular injury, deep infection, visual affection, pulmonary embolism, pleural effusion, deep venous thrombosis, implant-related problems, proximal junctional kyphosis, and re-operation for any cause.
    Time Frame
    Intraoperative, then Immediate, 2 weeks, 3 months, and 1 year postoperative
    Title
    American Spinal Injury Association (ASIA) Score
    Description
    A score developed by the American Spinal Injury Association for essential minimal elements of neurologic assessment for all patients with a spinal injury.
    Time Frame
    Baseline preoperative, then immediate, and 3 months postoperative
    Title
    Local Kyphosis Angle (LKA)
    Description
    Assessed on the lateral radiograph by measuring the angle obtained by a line parallel to the inferior endplate of the deformed vertebra and that of the vertebra one level above.
    Time Frame
    Baseline preoperative, then 2 weeks, and 1 year postoperative
    Title
    Lumbar Lordosis Angle (LLA)
    Description
    Angle measured between L1 and L5 lower end plates.
    Time Frame
    Baseline preoperative, then 2 weeks, and 1 year postoperative
    Title
    Thoracic Kyphosis Angle (TKA)
    Description
    Angle measured between T1 and T12 lower end plates.
    Time Frame
    Baseline preoperative, then 2 weeks, and 1 year postoperative
    Title
    Sagittal Vertical Axis (SVA) to C7 Plumb Line (C7PL)
    Description
    To quantify global alignment. It is defined as the sagittal offset of a plumb line dropped from the C7 vertebral body from the posterosuperior corner of the sacral plate.
    Time Frame
    Baseline preoperative, then 2 weeks, and 1 year postoperative
    Title
    Scoliosis Angle (Cobb's Angle)
    Description
    To measure and quantify the magnitude of spinal deformities, especially in the case of scoliosis. The Cobb angle measurement is the "gold standard" of scoliosis evaluation endorsed by Scoliosis Research Society. It is used as the standard measurement to quantify and track the progression of scoliosis.
    Time Frame
    Baseline preoperative, then 2 weeks, and 1 year postoperative
    Title
    Shoulder Balance (Clavicle Angle)
    Description
    It is the angle that is subtended between a horizontal reference line - clavicle horizontal reference line (CHRL), which is drawn perpendicular to the lateral edge of the radiograph and touches the most cephalad portion of the elevated clavicle and a line which touches the most cephalad aspect of both the right and left clavicles - clavicle reference line (CRL). By convention, angles subtended with the left shoulder up are positive and angles subtended with the right shoulder up are negative (consistent with directionality of the T1 tilt angle).
    Time Frame
    Baseline preoperative, then 2 weeks, and 1 year postoperative
    Title
    Central Sacral Vertical Line (CSVL) to C7 Plumb Line (C7PL)
    Description
    Coronal decompensation is measured as the horizontal distance between a plumb line dropped downward from the center of the C7 (C7PL) vertebral body and the central sacral vertical line (CSVL), which is a line drawn vertically through the center of the sacrum.
    Time Frame
    Baseline preoperative, then 2 weeks, and 1 year postoperative
    Title
    Body Height (BH)
    Description
    The height is measured using a measuring tape with patient standing without shoes.
    Time Frame
    Baseline preoperative, then 2 weeks, and 1 year postoperative
    Title
    T1-S1 Trunk Height (TH)
    Description
    The T1-S1 height of the spine and the T1-S1 length of the spine are measured and compared.
    Time Frame
    Baseline preoperative, then 2 weeks, and 1 year postoperative
    Title
    Leg Length Discrepancy (LLD)
    Description
    Radiographic measurement of difference between the lengths of the legs. Full-length standing anteroposterior radiograph compared with scanogram.
    Time Frame
    Baseline preoperative, then 1 year postoperative
    Title
    CT-based Classification for assessment of biological graft fusion
    Description
    A new assessment method of bony union using high-speed spiral CT imaging is proposed which reflects the gradually increasing biological stability of the construct. Grade I (complete fusion) implies cortical union of the allograft and central trabecular continuity. Grade II (partial fusion) implies cortical union of the structural allograft with partial trabecular incorporation. Grade III (unipolar pseudarthrosis) denotes superior or inferior cortical non-union of the central allograft with partial trabecular discontinuity centrally and Grade IV (bipolar pseudarthrosis) suggests both superior and inferior cortical non-union with a complete lack of central trabecular continuity.
    Time Frame
    1 year postoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Neglected congenital kyphoscoliotic spinal deformity Thoracic and Lumbar curves only Age more than 10 years old Exclusion Criteria: Cervical and Sacral deformities Revision failed back surgeries
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Shawky
    Phone
    +201010212222
    Email
    ahsh313@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Muhammad Almessry
    Phone
    +201007262147
    Email
    dr.muhammad.orthospine@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohamed El-Meshtawy
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Belal Elnady
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    18043375
    Citation
    Aydogan M, Ozturk C, Tezer M, Mirzanli C, Karatoprak O, Hamzaoglu A. Posterior vertebrectomy in kyphosis, scoliosis and kyphoscoliosis due to hemivertebra. J Pediatr Orthop B. 2008 Jan;17(1):33-7. doi: 10.1097/01.bpb.0000218031.75557.f0.
    Results Reference
    background
    PubMed Identifier
    19752708
    Citation
    Lenke LG, O'Leary PT, Bridwell KH, Sides BA, Koester LA, Blanke KM. Posterior vertebral column resection for severe pediatric deformity: minimum two-year follow-up of thirty-five consecutive patients. Spine (Phila Pa 1976). 2009 Sep 15;34(20):2213-21. doi: 10.1097/BRS.0b013e3181b53cba.
    Results Reference
    background
    PubMed Identifier
    19829255
    Citation
    Ayvaz M, Akalan N, Yazici M, Alanay A, Acaroglu RE. Is it necessary to operate all split cord malformations before corrective surgery for patients with congenital spinal deformities? Spine (Phila Pa 1976). 2009 Oct 15;34(22):2413-8. doi: 10.1097/BRS.0b013e3181b9c61b.
    Results Reference
    background
    PubMed Identifier
    19644330
    Citation
    Ruf M, Jensen R, Letko L, Harms J. Hemivertebra resection and osteotomies in congenital spine deformity. Spine (Phila Pa 1976). 2009 Aug 1;34(17):1791-9. doi: 10.1097/BRS.0b013e3181ab6290.
    Results Reference
    background
    PubMed Identifier
    15473678
    Citation
    Hedequist D, Emans J. Congenital scoliosis. J Am Acad Orthop Surg. 2004 Jul-Aug;12(4):266-75. doi: 10.5435/00124635-200407000-00007.
    Results Reference
    background
    PubMed Identifier
    29462064
    Citation
    Soliman HAG. Health-related Quality of Life of Adolescents With Severe Untreated Congenital Kyphosis and Kyphoscoliosis in a Developing Country. Spine (Phila Pa 1976). 2018 Aug;43(16):E942-E948. doi: 10.1097/BRS.0000000000002598.
    Results Reference
    background
    PubMed Identifier
    21424339
    Citation
    Wang Y, Lenke LG. Vertebral column decancellation for the management of sharp angular spinal deformity. Eur Spine J. 2011 Oct;20(10):1703-10. doi: 10.1007/s00586-011-1771-0. Epub 2011 Mar 19.
    Results Reference
    background
    PubMed Identifier
    29664852
    Citation
    Lenke LG, Shaffrey CI, Carreon LY, Cheung KMC, Dahl BT, Fehlings MG, Ames CP, Boachie-Adjei O, Dekutoski MB, Kebaish KM, Lewis SJ, Matsuyama Y, Mehdian H, Pellise F, Qiu Y, Schwab FJ; AO Spine International and SRS Scoli-RISK-1 Study Group. Lower Extremity Motor Function Following Complex Adult Spinal Deformity Surgery: Two-Year Follow-up in the Scoli-RISK-1 Prospective, Multicenter, International Study. J Bone Joint Surg Am. 2018 Apr 18;100(8):656-665. doi: 10.2106/JBJS.17.00575.
    Results Reference
    background
    PubMed Identifier
    19727995
    Citation
    Lenke LG, Sides BA, Koester LA, Hensley M, Blanke KM. Vertebral column resection for the treatment of severe spinal deformity. Clin Orthop Relat Res. 2010 Mar;468(3):687-99. doi: 10.1007/s11999-009-1037-x. Epub 2009 Sep 1.
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    Citation
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    Vertebral Column Resection (VCR) in Congenital Kyphoscoliosis (CKS)

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