Does laminectomy alone or laminectomy with fusion lead to better recovery in patients undergoing surgery for degenerative cervical myelopathy from the back?

POsterior Laminectomy and FIXation for Degenerative Cervical Myelopathy [POLYFIX-DCM]

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12638817

Enrollment

394

Registered

2022-02-11

Start date

2022-03-01

Completion date

Unknown

Last updated

2025-03-17

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

Conditions

Degenerative cervical myelopathy Musculoskeletal Diseases

Interventions

POLYFIX DCM will be a multi-centre pragmatic, randomised trial, with blinded outcome assessment, aiming to determine the comparative clinical- and cost-effectiveness of decompression and fusion, with

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Have given written informed consent to participate 2. Be aged 18 years and over 3. Have a diagnosis of DCM, based on established criteria 4. Be scheduled for posterior surgery, involving two or more consecutive laminae 5. Be able to read and understand English

Exclusion criteria

Exclusion criteria: 1. Mild and non-progressive DCM (defined as stable mJOA score >16 at two consecutive time points) 2. Presentation in the context of acute trauma (e.g. central cord syndrome or spinal cord injury)

Design outcomes

Primary

Measure	Time frame
Neurological outcome measured using the Modified Japanese Orthopaedic Association score (mJOA) at 24 months	—

Secondary

Measure	Time frame
1. Pain measured using the VAS pain at 6, 12 and 24 months 2. Quality of life measured using the SF36v2 Score (Physical Component Score, Mental Component Score and Bodily Pain) at 6, 12 and 24 months 3. Quality of life measured using the EQ5D-5L at 6, 12 and 24 months 4. Pain/neck disability measured using the Neck Disability Index (NDI) at 6, 12 and 24 months 5. Pain/neck disability measured using the Brief Pain Inventory (BPI) at 6, 12 and 24 months 6. Pain measured using the Douleur Neuropathique 4 (DN4) at 6, 12 and 24 months 7. Pain measured using the Michigan Body Map (Pain Location) at 6, 12 and 24 months 8. Procedural complications, including intraoperative blood loss, dural tear, surgical site infection, wound breakdown and instrument failure, measured using case notes review at the time of surgery/post-operative period 9. Adverse events measured using patient interview, clinic and telephone visits at 6, 12 and 24 months 10. Length of hospital stay, measured using hospital electronic patient records (EPR) at discharge 11. Length of operation, measured using hospital EPR post-operatively 12. Discharge destination, measured using hospital EPR at time of discharge. 13. Alignment (C2–7 lordosis, C2–7 sagittal vertical axis and T1 slope), fusion and movement assessed using cervical, dynamic x-rays at 6, 12 and 24 months 14. Quality of life measured using the Myelopathy.org symptom inventory at 6, 12 and 24 months	—

Measure

Time frame

1. Pain measured using the VAS pain at 6, 12 and 24 months 2. Quality of life measured using the SF36v2 Score (Physical Component Score, Mental Component Score and Bodily Pain) at 6, 12 and 24 months 3. Quality of life measured using the EQ5D-5L at 6, 12 and 24 months 4. Pain/neck disability measured using the Neck Disability Index (NDI) at 6, 12 and 24 months 5. Pain/neck disability measured using the Brief Pain Inventory (BPI) at 6, 12 and 24 months 6. Pain measured using the Douleur Neuropathique 4 (DN4) at 6, 12 and 24 months 7. Pain measured using the Michigan Body Map (Pain Location) at 6, 12 and 24 months 8. Procedural complications, including intraoperative blood loss, dural tear, surgical site infection, wound breakdown and instrument failure, measured using case notes review at the time of surgery/post-operative period 9. Adverse events measured using patient interview, clinic and telephone visits at 6, 12 and 24 months 10. Length of hospital stay, measured using hospital electronic patient records (EPR) at discharge 11. Length of operation, measured using hospital EPR post-operatively 12. Discharge destination, measured using hospital EPR at time of discharge. 13. Alignment (C2–7 lordosis, C2–7 sagittal vertical axis and T1 slope), fusion and movement assessed using cervical, dynamic x-rays at 6, 12 and 24 months 14. Quality of life measured using the Myelopathy.org symptom inventory at 6, 12 and 24 months

—

Countries

England, Scotland, United Kingdom, Wales

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026