Congenital Spinal DeformityNCT03524027
Vertebral Column Resection (VCR) in Congenital Kyphoscoliosis (CKS)
A study testing Posterior Vertebral Column Resection (PVCR) in people with Congenital Spinal Deformity and Congenital Kyphoscoliosis, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Congenital Spinal Deformity, Congenital Kyphoscoliosis
- What is being tested?
- Posterior Vertebral Column Resection (PVCR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2018to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Neglected congenital kyphoscoliotic spinal deformity
- Thoracic and Lumbar curves only
- Age more than 10 years old
Who cannot join
- Cervical and Sacral deformities
- Revision failed back surgeries
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Posterior Vertebral Column Resection (PVCR) for Correction of Adolescent Thoracolumbar Congenital Kyphoscoliosis (CKS)
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.
Read the 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.
- Being tested
- Posterior Vertebral Column Resection (PVCR)
- Keywords
- Vertebral Column Resection, Congenital Spinal Deformity, Congenital Thoracolumbar Kyphoscoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior Vertebral Column Resection (PVCR)Procedure or surgery
Also called Vertebrectomy, Corpectomy, Spondylectomy, VCR
Posterior Vertebral Column Resection (PVCR) Surgical Technique for Correction of Adolescent Thoracolumbar Congenital Kyphoscoliosis (CKS) Spinal Deformity
| Study group | Role | What they receive |
|---|---|---|
| Congenital Thoracolumbar Kyphoscoliosis | Experimental | Correction of Adolescent Thoracolumbar Congenital Kyphoscoliosis (CKS) Spinal Deformity by Posterior Vertebral Column Resection (PVCR) Surgical Technique Receives: Procedure: Posterior Vertebral Column Resection (PVCR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline preoperative, then 3 months, and 1 year postoperative
Secondary outcomes (15)
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.
Measured: Baseline preoperative, then 3 months, and 1 year postoperative
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.
Measured: Baseline preoperative, then 3 months, and 1 year postoperative
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.
Measured: Intraoperative, then Immediate, 2 weeks, 3 months, and 1 year postoperative
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.
Measured: Baseline preoperative, then immediate, and 3 months postoperative
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.
Measured: Baseline preoperative, then 2 weeks, and 1 year postoperative
Lumbar Lordosis Angle (LLA)
Angle measured between L1 and L5 lower end plates.
Measured: Baseline preoperative, then 2 weeks, and 1 year postoperative
Thoracic Kyphosis Angle (TKA)
Angle measured between T1 and T12 lower end plates.
Measured: Baseline preoperative, then 2 weeks, and 1 year postoperative
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.
Measured: Baseline preoperative, then 2 weeks, and 1 year postoperative
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.
Measured: Baseline preoperative, then 2 weeks, and 1 year postoperative
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).
Measured: Baseline preoperative, then 2 weeks, and 1 year postoperative
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.
Measured: Baseline preoperative, then 2 weeks, and 1 year postoperative
Body Height (BH)
The height is measured using a measuring tape with patient standing without shoes.
Measured: Baseline preoperative, then 2 weeks, and 1 year postoperative
T1-S1 Trunk Height (TH)
The T1-S1 height of the spine and the T1-S1 length of the spine are measured and compared.
Measured: Baseline preoperative, then 2 weeks, and 1 year postoperative
Leg Length Discrepancy (LLD)
Radiographic measurement of difference between the lengths of the legs. Full-length standing anteroposterior radiograph compared with scanogram.
Measured: Baseline preoperative, then 1 year postoperative
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.
Measured: 1 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study startMay 2018 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Congenital Spinal DeformityStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Almessry, Assiut University
- Investigators
- Mohamed El-Meshtawy, Study chair, Assiut UniversityBelal Elnady, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524027
- Sponsor's protocol ID
- PVCR
- Status last verified
- May 2018
- First submitted
- 26 Apr 2018
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18043375Lenke 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.
PubMed 19752708Ayvaz 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.
PubMed 19829255Ruf 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.
PubMed 19644330Hedequist D, Emans J. Congenital scoliosis. J Am Acad Orthop Surg. 2004 Jul-Aug;12(4):266-75. doi: 10.5435/00124635-200407000-00007.
PubMed 15473678Soliman 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.
PubMed 29462064Wang 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.
PubMed 21424339Lenke 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.
PubMed 29664852Lenke 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.
PubMed 19727995Lenke 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.
PubMed 22825478
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Vertebral Column Resection (PVCR) for Correction of Adolescent Thoracolumbar Congenital Kyphoscoliosis (CKS)
- ClinicalTrials.gov ID
- NCT03524027
- Acronym / sponsor ID
- PVCR
- Keywords
- Vertebral Column Resection, Congenital Spinal Deformity, Congenital Thoracolumbar Kyphoscoliosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2018 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 14 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Congenital Thoracolumbar Kyphoscoliosis | Experimental | Procedure: Posterior Vertebral Column Resection (PVCR)Correction of Adolescent Thoracolumbar Congenital Kyphoscoliosis (CKS) Spinal Deformity by Posterior Vertebral Column Resection (PVCR) Surgical Technique |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Neglected congenital kyphoscoliotic spinal deformity
- Thoracic and Lumbar curves only
- Age more than 10 years old
Key exclusion criteria (2 listed)
- Cervical and Sacral deformities
- Revision failed back surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterior Vertebral Column Resection (PVCR)Also: Vertebrectomy, Corpectomy, Spondylectomy, VCRPosterior Vertebral Column Resection (PVCR) Surgical Technique for Correction of Adolescent Thoracolumbar Congenital Kyphoscoliosis (CKS) Spinal Deformity | Procedure or surgery | Congenital Thoracolumbar Kyphoscoliosis |
Primary outcome
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.
15 secondary outcomes
Oswestry Disability Index (ODI)
Time frame: Baseline preoperative, then 3 months, and 1 year postoperative
Short Form (SF)-36 Health Survey
Time frame: Baseline preoperative, then 3 months, and 1 year postoperative
Complications Rate
Time frame: Intraoperative, then Immediate, 2 weeks, 3 months, and 1 year postoperative
American Spinal Injury Association (ASIA) Score
Time frame: Baseline preoperative, then immediate, and 3 months postoperative
Local Kyphosis Angle (LKA)
Time frame: Baseline preoperative, then 2 weeks, and 1 year postoperative
Lumbar Lordosis Angle (LLA)
Time frame: Baseline preoperative, then 2 weeks, and 1 year postoperative
Thoracic Kyphosis Angle (TKA)
Time frame: Baseline preoperative, then 2 weeks, and 1 year postoperative
Sagittal Vertical Axis (SVA) to C7 Plumb Line (C7PL)
Time frame: Baseline preoperative, then 2 weeks, and 1 year postoperative
Scoliosis Angle (Cobb's Angle)
Time frame: Baseline preoperative, then 2 weeks, and 1 year postoperative
Shoulder Balance (Clavicle Angle)
Time frame: Baseline preoperative, then 2 weeks, and 1 year postoperative
Central Sacral Vertical Line (CSVL) to C7 Plumb Line (C7PL)
Time frame: Baseline preoperative, then 2 weeks, and 1 year postoperative
Body Height (BH)
Time frame: Baseline preoperative, then 2 weeks, and 1 year postoperative
T1-S1 Trunk Height (TH)
Time frame: Baseline preoperative, then 2 weeks, and 1 year postoperative
Leg Length Discrepancy (LLD)
Time frame: Baseline preoperative, then 1 year postoperative
CT-based Classification for assessment of biological graft fusion
Time frame: 1 year postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
- Background: PubMed 18043375Aydogan 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.
- Background: PubMed 19752708Lenke 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.
- Background: PubMed 19829255Ayvaz 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.
- Background: PubMed 19644330Ruf 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.
- Background: PubMed 15473678Hedequist D, Emans J. Congenital scoliosis. J Am Acad Orthop Surg. 2004 Jul-Aug;12(4):266-75. doi: 10.5435/00124635-200407000-00007.
- Background: PubMed 29462064Soliman 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.
- Background: PubMed 21424339Wang 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.
- Background: PubMed 29664852Lenke 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.
- Background: PubMed 19727995Lenke 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.
- Background: PubMed 22825478Lenke 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed El-Meshtawy study chair
Assiut University
Belal Elnady principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Posterior Vertebral Column Resection (PVCR) in people with Congenital Spinal Deformity and Congenital Kyphoscoliosis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Shawky (+201010212222, ahsh313@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03524027, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2018.