Anterior cervical spine fusion study

Not yet recruiting

• Conditions: Cervical disc disorder, unspecified,

• Registration Number: CTRI/2021/01/030690
• Lead Sponsor: Sakra World Hospital

Brief Summary

This academic study will be done at Sakra World Hospital. The patients (56) with degenerative cervical diseases and who fulfill the selection criteria will be randomized and will be grouped into Group A (28) - Grafton and Group B (28) - bone graft group. Both groups will be operated with Anterior cervical fusion surgeries with Divergence cage and the cage will be filled with Grafton - DBM in A group and local bone graft in B group. They will be analyzed and compared at 0,3,6,12 months both clinically and radiologically (Xray and CT). The clinical parameters that will be analyzed are m-JOA, VAS score for neck and radicular pain, Nuricks, Odoms criteria, and NDI. Radiologically they will be analyzed for fusion status and the time taken for fusion. The outcomes will be analyzed, compared and appropriate statistics will be applied for the interpretation of results

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-01-22
• Study Start: 2021-01-27

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Patients with Degenerative disease of the cervical spine and •Radiculopathy •Myelopathy •Kyphosis and disability.

Exclusion Criteria

•Infections / Trauma requiring ACDF •ACDF Procedures combined with posterior surgeries •Patients with more than 2 level pathology •Severe medical co-morbidities precluding surgery •Patients who have undergone surgery in Cervical region previously.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fusion	Baseline,1,3,6,12 months

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS) score pain assessment, mJOA (modified Japanese Orthopaedic Association) score, NDI (Neck disability index) and Odom’s criteria	Baseline,1,3,6,12 months

Trial Locations

Locations (1)

Sakra World Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Sakra World Hospital

🇮🇳Bangalore, KARNATAKA, India

Satish Rudrappa

Principal investigator

9844020211

drsatishr@gmail.com