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A study in patients with cervical spine disease comparing two types of decompression surgery and the use of nerve monitoring to improve recovery

Intraoperative neuromonitoring and clinical outcomes of en bloc versus piecemeal laminectomy in cervical spondylotic myelopathy: A prospective randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109844
Enrollment
100
Registered
2026-04-30
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M480- Spinal stenosis

Interventions

Intervention1: Posterior cervical enbloc laminectomy and instrumentation: Posterior cervical decompression will be performed by enbloc laminectomy at the clinically and radiologically involved levels.

Sponsors

Ganga Orthopaedics Research and Education Foundation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients more than 18 years of age, 2. Clinical diagnosis of cervical myelopathy, 3. Multilevel involvement - more than 2 levels requiring posterior decompression, 3. Neutral or lordotic cervical spine, 4. Ability to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. cervical kyphosis 2. Conditions requiring anterior and posterior surgery 3. Previous cervical spine surgery 4. Trauma, infection, tumor, or inflammatory spinal disease

Design outcomes

Primary

MeasureTime frame
To compare the intraoperative neuromonitoring responses, specifically motor-evoked potentials (MEPs) and somatosensory-evoked potentials (SEPs), between en bloc and piecemeal laminectomy techniques in patients undergoing surgery for cervical spondylotic myelopathy, with respect to the incidence of signal improvement, deterioration, or no change during decompression.Timepoint: Intraoperative: Neuromonitoring alerts, operative time, blood loss Within 48 hours: Neurological status At discharge: Neurological status 6 weeks: mJOA score 3 months: Neurological status and mJOA score—

Secondary

MeasureTime frame
To compare the incidence of intraoperative and postoperative neurological complications, including transient or persistent neurological worsening, between the two groups. To assess and compare clinical neurological outcomes using the modified Japanese Orthopaedic Association (mJOA) score at follow-up. To compare the incidence of dural tear and postoperative cerebrospinal fluid leakage, operating time, and blood loss between en bloc and piecemeal laminectomy techniques. To analyze the relationship between intraoperative neuromonitoring changes and postoperative neurological recovery in patients undergoing posterior cervical decompression.Timepoint: preop, immediate postop, 24 hours, 48 hours, 72 hours, 3 months, 6 months, 1 year—

Countries

India

Contacts

Public ContactProf S Rajasekaran
rajasekaran.orth@gmail.com08668173135

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026