Congenital Kyphoscoliosis Clinical Trial
Official title:
Posterior Vertebral Column Resection (PVCR) for Correction of Adolescent Thoracolumbar Congenital Kyphoscoliosis (CKS)
| NCT number | NCT03524027 |
| Other study ID # | PVCR |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 2018 |
| Est. completion date | May 2020 |
| Verified date | May 2018 |
| Source | Assiut University |
| Contact | Ahmed Shawky |
| Phone | +201010212222 |
| ahsh313[@]yahoo.com | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Not yet recruiting |
| Enrollment | 20 |
| Est. completion date | May 2020 |
| Est. primary completion date | May 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 10 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Assiut University |
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. — View 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. — View Citation
Hedequist D, Emans J. Congenital scoliosis. J Am Acad Orthop Surg. 2004 Jul-Aug;12(4):266-75. Review. — View Citation
Lenke LG, Newton PO, Sucato DJ, Shufflebarger HL, Emans JB, Sponseller PD, Shah SA, Sides BA, Blanke KM. Complications after 147 consecutive vertebral column resections for severe pediatric spinal deformity: a multicenter analysis. Spine (Phila Pa 1976). 2013 Jan 15;38(2):119-32. doi: 10.1097/BRS.0b013e318269fab1. — View 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. — View 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, Pellisé 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. — View 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. — View 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. — View 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 Feb 16. doi: 10.1097/BRS.0000000000002598. [Epub ahead of print] — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Baseline preoperative, then 3 months, and 1 year postoperative | |
| Secondary | 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. | Baseline preoperative, then 3 months, and 1 year postoperative | |
| Secondary | 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. | Baseline preoperative, then 3 months, and 1 year postoperative | |
| Secondary | 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. | Intraoperative, then Immediate, 2 weeks, 3 months, and 1 year postoperative | |
| Secondary | 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. | Baseline preoperative, then immediate, and 3 months postoperative | |
| Secondary | 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. | Baseline preoperative, then 2 weeks, and 1 year postoperative | |
| Secondary | Lumbar Lordosis Angle (LLA) | Angle measured between L1 and L5 lower end plates. | Baseline preoperative, then 2 weeks, and 1 year postoperative | |
| Secondary | Thoracic Kyphosis Angle (TKA) | Angle measured between T1 and T12 lower end plates. | Baseline preoperative, then 2 weeks, and 1 year postoperative | |
| Secondary | 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. | Baseline preoperative, then 2 weeks, and 1 year postoperative | |
| Secondary | 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. | Baseline preoperative, then 2 weeks, and 1 year postoperative | |
| Secondary | 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). | Baseline preoperative, then 2 weeks, and 1 year postoperative | |
| Secondary | 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. | Baseline preoperative, then 2 weeks, and 1 year postoperative | |
| Secondary | Body Height (BH) | The height is measured using a measuring tape with patient standing without shoes. | Baseline preoperative, then 2 weeks, and 1 year postoperative | |
| Secondary | T1-S1 Trunk Height (TH) | The T1-S1 height of the spine and the T1-S1 length of the spine are measured and compared. | Baseline preoperative, then 2 weeks, and 1 year postoperative | |
| Secondary | Leg Length Discrepancy (LLD) | Radiographic measurement of difference between the lengths of the legs. Full-length standing anteroposterior radiograph compared with scanogram. | Baseline preoperative, then 1 year postoperative | |
| Secondary | 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. | 1 year postoperative |