:::Association of Spine Surgeons of India ::: www.assiweb.org :::

ASSI Research Forum

The Association of Spine Surgeons of India is conducting 3 multicentric trials /studies.

For further details kindly contact the co-ordinators directly:

1.	Spinal cord Injury/Trauma study Co-ordinator : Dr. H S Chhabra issicon@isiconline.org
2.	Low back Pain Study Co-ordinator : Dr. S Y Bhojraj spine_clinic@rediffmail.com
3.	Spine Tuberculosis Study Co-ordinator : Dr. A K Jain correspondence to Dr. Abhay Nene abhaynene@yahoo.com

Multicentric ASSI for an SCI data base

ASSI is conducting a “Multicentric ASSI for an SCI data base”. Centers having a reasonable turnover of spinal cord injury patients have been included for the study. International Spinal Cord Injury Data set’s Core Data Set collection form has been modified for use for this study (copy of modified form enclosed at Annexure A).

The data base now includes data for 89 patients. At the completion of one year, the preliminary analysis of the data would be done.

A Comparison of the Different Methods for Surgical Management of Thoracolumbar Burst Fractures: An ASSI Collaborative Multicentric Study

Approximately 90% of all spinal fractures occur in thoracic and lumbar spines1. In fact, the majority of the thoracic and lumbar fractures occur within the region between T11 and L1 commonly referred to as the thoracolumbar junction2. Many of these fractures are unstable and may result in neurological deficits needing surgical management.

Aims & Objective: To study the clinical and radiological out-come of different surgical methods of management of thoracolumbar burst fractures, the different methods being primary anterior decompression and stabilization only, primary posterior stabilization only or combined anterior with posterior procedure (single stage as well as staged procedures).

Need for the Study: Unsettled controversies exist regarding treatment of burst fractures at the thoracolumbar level3.

Different options of surgical treatment of thoracolumbar burst fractures are – primary anterior approach only, primary posterior approach or the combination of the two in a staged or un-staged manner. Different “schools" may all claim to be providing the optimal care for these fractures, yet evidence based guidelines are lacking8.

Materials and methods: This is a multi-centric randomized prospective study which will be conducted between July 2008 and June 2009 at specialized spine centers spread over different geographic locations in India, aiming to include a minimum of 60 patients.

Inclusion Criteria

•	Patient between 18 and 60 yr
•	Patient with traumatic burst fracture involving D11, D12 or L1 (AO-AISF: A3)11
•	Patient with neurological deficit
•	History of significant trauma
•	Patient presenting within two weeks of trauma

Exclusion criteria

•	Patient with pathological and fragility fractures,
•	Patient with multiple fractures
•	Patient with psychiatric illness
•	Patient with previous back surgery
•	Obese patient (BMI >30)
•	Pregnancy

All patients who are willing for the study and fulfill the criteria will be included in the study.

Patients would be divided broadly into 2 groups based on the ‘load sharing classification’10 (Annexure)

•	Group 1 consists of patient having LSC < 7.
•	Group 2 consist of patient having LSC ≥7.

Once a subject fulfilling the inclusion criteria approaches any of the study centers the concerned doctor from the centre would contact Dr. Amrithlal A.M. (Spine Fellow-Indian Spinal Injuries Centre, Research Coordinator– Thoracolumbar Burst Fracture study, mobile contact: 09968127070, email: amrithlalam@gmail.com) who would then randomize patients of each group manually through draw of chits into 3 subgroups as under:

Group 1: <7 LSC Score
•	Group1 a - patient treated by anterior approach only
•	Group1 b – patient treated by posterior approach only
•	Group1 c – patient treated by combined anterior and posterior approach

Group 2: ≥7 LSC score
•	Group 2 a – patient treated by anterior approach only
•	Group 2 b – patient treated by same sitting anterior and posterior approach
•	Group 2 c – patient treated by staged anterior and posterior approach

Standard protocol will be maintained with regards to patient assessment and selection, randomization, surgical methods and post-operative management so as to minimize the bias.

Bone graft would be harvested from iliac crest. All subjects will undergo a short segment pedicle screw fixation – one level above and below the fracture.

Intra-operative complications, total blood loss, total time of surgery would be noted. Preoperatively intravenous 1gm of cefazoline and 60 mg of gentamycin would be given followed by every 12 hourly for 3 days post operatively.

Post-operatively the patient would be mobilized wearing an APTLSO / ASH brace. A standardized rehabilitation programmed would be followed. Rehabilitation program started 3-5 days post operatively.

The following outcome evaluation parameters would be studied (Check annexure for details):

Clinical
•	Neurological status using ASIA scale
•	Status of pain using visual analogue score
•	Spinal cord independence measure

Radiological
•	Cobb’s angle 9
•	Vertebral body compression ratio 9
•	Sagittal index 9
•	Canal compromise percentage 9
•	Status of Fusion

Data sampling, follow-up and statistics:

Data would be sampled for LSC score10 and AO fracture classification11 in order to allocate into different groups which will be randomized further into the sub-groups. Preoperative X-rays (AP/ Lateral views), CT scan and MRI scan of the dorso-lumbar spine is mandatory for this. Treatment associated complications, total duration of surgery; total blood loss during surgery and other details will be recorded in the proforma for analysis. Assessment will be performed at admission, on 2nd post-operative day and 3 months, 6 months, and 12 months following surgery and detailed examination for deformity progression, VAS scoring, ASIA charting for neurological status will be done. X-ray AP/Lateral views, CT and MRI would be taken post-operatively, and X-ray AP/LAT view at subsequent follow-ups to look for deformity progression, implant status and fusion status. Fusion assessment will be based on analysis of lateral plain radiographs7. Functional scores would be obtained and compared with the baseline data before the accident as described by the patient.

Interim Report

15 cases have been recruited for the study. These patients which were assessed for the load sharing score (<7 or above) and were further randomized for allotment of the surgical procedure.

Following is the distribution of the cases in the study till date:

Load sharing score <7
•	Posterior instrumentation only	1
•	Anterior instrumentation only	1
•	Anterior and Posterior	6

Load Sharing Score of 7 and above
•	Anterior and posterior (Single Stage)	2
•	Anterior and posterior (2 Stage)	2
•	Anterior instrumentation only	1

These cases are under followed up regularly and a detailed proforma is being used for documentation.

Centers from all over India have been appraised regarding the study by e-mail and personal conversation and a single point contact number has been provided. Unfortunately the cases have come only from ISIC and AIIMS.

Click here for TB Project details