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

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ClinicalTrials.gov Identifier: NCT03524027
Recruitment Status : Unknown
Verified May 2018 by Muhammad Almessry, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : May 14, 2018
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Muhammad Almessry, Assiut University

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.


Condition or disease Intervention/treatment Phase
Congenital Spinal Deformity Congenital Kyphoscoliosis Procedure: Posterior Vertebral Column Resection (PVCR) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Posterior Vertebral Column Resection (PVCR) for Correction of Adolescent Thoracolumbar Congenital Kyphoscoliosis (CKS)
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Experimental: Congenital Thoracolumbar Kyphoscoliosis
Correction of Adolescent Thoracolumbar Congenital Kyphoscoliosis (CKS) Spinal Deformity by Posterior Vertebral Column Resection (PVCR) Surgical Technique
Procedure: Posterior Vertebral Column Resection (PVCR)
Posterior Vertebral Column Resection (PVCR) Surgical Technique for Correction of Adolescent Thoracolumbar Congenital Kyphoscoliosis (CKS) Spinal Deformity
Other Names:
  • Vertebrectomy
  • Corpectomy
  • Spondylectomy
  • VCR




Primary Outcome Measures :
  1. Change in Scoliosis Research Society (SRS)-24 (arabic version) Health-related quality of life questionnaire [ Time Frame: Baseline preoperative, then 3 months, and 1 year postoperative ]
    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 :
  1. Oswestry Disability Index (ODI) [ Time Frame: Baseline preoperative, then 3 months, and 1 year postoperative ]
    Is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.

  2. Short Form (SF)-36 Health Survey [ Time Frame: Baseline preoperative, then 3 months, and 1 year postoperative ]
    Is widely validated and popularly used in assessing the subjective quality of life (QOL) of patients and the general public.

  3. Complications Rate [ Time Frame: Intraoperative, then Immediate, 2 weeks, 3 months, and 1 year postoperative ]
    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.

  4. American Spinal Injury Association (ASIA) Score [ Time Frame: Baseline preoperative, then immediate, and 3 months postoperative ]
    A score developed by the American Spinal Injury Association for essential minimal elements of neurologic assessment for all patients with a spinal injury.

  5. Local Kyphosis Angle (LKA) [ Time Frame: Baseline preoperative, then 2 weeks, and 1 year postoperative ]
    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.

  6. Lumbar Lordosis Angle (LLA) [ Time Frame: Baseline preoperative, then 2 weeks, and 1 year postoperative ]
    Angle measured between L1 and L5 lower end plates.

  7. Thoracic Kyphosis Angle (TKA) [ Time Frame: Baseline preoperative, then 2 weeks, and 1 year postoperative ]
    Angle measured between T1 and T12 lower end plates.

  8. Sagittal Vertical Axis (SVA) to C7 Plumb Line (C7PL) [ Time Frame: Baseline preoperative, then 2 weeks, and 1 year postoperative ]
    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.

  9. Scoliosis Angle (Cobb's Angle) [ Time Frame: Baseline preoperative, then 2 weeks, and 1 year postoperative ]
    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.

  10. Shoulder Balance (Clavicle Angle) [ Time Frame: Baseline preoperative, then 2 weeks, and 1 year postoperative ]
    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).

  11. Central Sacral Vertical Line (CSVL) to C7 Plumb Line (C7PL) [ Time Frame: Baseline preoperative, then 2 weeks, and 1 year postoperative ]
    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.

  12. Body Height (BH) [ Time Frame: Baseline preoperative, then 2 weeks, and 1 year postoperative ]
    The height is measured using a measuring tape with patient standing without shoes.

  13. T1-S1 Trunk Height (TH) [ Time Frame: Baseline preoperative, then 2 weeks, and 1 year postoperative ]
    The T1-S1 height of the spine and the T1-S1 length of the spine are measured and compared.

  14. Leg Length Discrepancy (LLD) [ Time Frame: Baseline preoperative, then 1 year postoperative ]
    Radiographic measurement of difference between the lengths of the legs. Full-length standing anteroposterior radiograph compared with scanogram.

  15. CT-based Classification for assessment of biological graft fusion [ Time Frame: 1 year postoperative ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524027


Contacts
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Contact: Ahmed Shawky +201010212222 ahsh313@yahoo.com
Contact: Muhammad Almessry +201007262147 dr.muhammad.orthospine@gmail.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Chair: Mohamed El-Meshtawy Assiut University
Principal Investigator: Belal Elnady Assiut University
Publications:

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Responsible Party: Muhammad Almessry, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03524027    
Other Study ID Numbers: PVCR
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Muhammad Almessry, Assiut University:
Vertebral Column Resection
Congenital Spinal Deformity
Congenital Thoracolumbar Kyphoscoliosis
Additional relevant MeSH terms:
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Congenital Abnormalities