Does laminectomy alone or laminectomy with fusion lead to better recovery in patients undergoing surgery for degenerative cervical myelopathy from the back?
| ISRCTN | ISRCTN12638817 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12638817 |
| IRAS number | 297923 |
| Secondary identifying numbers | CPMS 50908, IRAS 297923 |
- Submission date
- 09/02/2022
- Registration date
- 11/02/2022
- Last edited
- 03/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Degenerative cervical myelopathy [DCM] is a common condition caused when arthritic changes in the neck compress the spinal cord. It affects up to 2% of adults and causes numb and clumsy hands, imbalance, and bladder problems. Often it continues to worsen with time and left untreated lead to severe disability and paralysis. The only current treatment is surgery, and a number of different operations are used. The aim of surgery is to create space for the spinal cord. Surgery is able to stop further deterioration and lead to some improvements.
For people who need DCM surgery from the back of their neck, the pressure on the spinal cord is relieved by removing part of the bone that surrounds the spinal cord called the laminae. This procedure on its own is called a laminectomy. In some cases, metal implants are placed in addition to the laminectomy in order to stiffen the spine. This is called laminectomy and fusion. Both procedures have potential advantages and disadvantages. The aim of this study is to find out whether laminectomy and fusion improves outcomes following surgery for DCM compared to laminectomy alone.
Who can participate?
Patients aged 18 years and over who are scheduled to undergo posterior surgery for DCM with multilevel compression
What does the study involve?
Participants are randomly allocated to treatment with either laminectomy alone or laminectomy and fusion.
What are the possible benefits and risks of participating?
Laminectomy alone is a more straightforward and shorter surgery that does not affect the range of movement in the neck. However, without fusion a change in the alignment of the spine called deformity may develop. Some surgeons believe deformity may affect long-term recovery and may cause greater neck pain for some people. Laminectomy and fusion aims to prevent this deformity but in doing so will greatly reduce the range of movement in the neck (particularly looking over the left or right shoulder). Some people find this a problem for everyday life, such as driving. Furthermore, the insertion of metalwork slightly increases the risks of the surgery, whilst greatly increasing the cost.
Where is the study run from?
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge (UK)
When is the study starting and how long is it expected to run for?
April 2020 to November 2028
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Mr Stefan Yordanov, s.yordanov@nhs.net
Contact information
Scientific
Cambridge University Hospital
Neuroscience Department
Hills Rd
Cambridge
CB2 0QQ
United Kingdom
 ORCID ID |
0000-0001-7008-6012 |
|---|---|
| Phone | +44 (0)7874649949 |
| s.yordanov@nhs.net |
Study information
| Study design | Randomized; Interventional; Design type: Treatment, Surgery |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | POsterior Laminectomy and FIXation for Degenerative Cervical Myelopathy [POLYFIX-DCM] |
| Study acronym | POLYFIX DCM |
| Study hypothesis | Laminectomy and fusion improves outcomes following surgery for multi-level degenerative cervical myelopathy (DCM) when compared to laminectomy alone. |
| Ethics approval(s) | Approved 02/12/2021, HRA and Health and Care Research Wales (HCRW, Castlebridge 4, 15 - 19 Cowbridge Rd E, Cardiff, CF11 9AB, UK; +44 (0)29 2023 0457; hcrw.approvals@wales.nhs.uk), REC ref: 21/YH/0253 |
| Condition | Degenerative cervical myelopathy |
| Intervention | 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 decompression alone for multi-level DCM treated posteriorly. Due to the nature of the trial, the local clinical teams, patients and carers cannot be blinded to allocation. However, by employing centralised telephone follow-up, a blinded assessment of the primary outcome can be performed. The trial will be preceded by an internal pilot in order to confirm recruitment, randomisation, treatment, and follow-up assessments. POLYFIX DCM will address the following hypothesis: 'Laminectomy and fusion improves outcomes following surgery for multi-level degenerative cervical myelopathy when compared to laminectomy alone.' The primary outcome measure for this trial is the modified Japanese Orthopaedic Association Score (mJOA). The mJOA was therefore selected as the single primary end-point, on the basis: 1. The recovery priorities for patients are pain, hand and walking function 2. The mJOA is the international standard, and most validated measure for the assessment of neuromuscular function in DCM and has been the primary endpoint for most leading trials. It primarily evaluates motor dysfunction in the upper and lower extremities but also altered sensation (including pain) to the hand(s) and sphincter dysfunction 3. Pain is a complex experience, and a single pain outcome tool has not been specifically validated for use in DCM 4. The NIHR HTA (funder) favoured a single primary endpoint (vs co-primary endpoint) 5. Although traditionally a clinician-administered score, a version has now been developed for use remotely, potentially more conducive to current NHS practice due to the COVID-19 pandemic The researchers plan to include 394 participants in this trial from approximately 20-30 sites in the UK and 5-10 sites internationally. In anticipation of requirements to optimise recruitment processes they propose initially three patient focus groups of 3-6 people (one within the pilot phase, two within the substantive phase) conducted online using Zoom or an equivalent videoconferencing system. These workshops will focus on understanding individual experiences and are not designed to change their opinions. Participation will be voluntary. Potentially eligible patients with DCM will be approached by a delegated member of the local trial team and given a participant information sheet to read in their own time. If they decide to participate in the trial, they will undergo a screening assessment to confirm their eligibility for the trial. Screening assessments will assess the following at an outpatient appointment: age, mJOA, planned surgical intervention, DCM characteristics (symptoms, length of DCM symptoms), MRI image findings (number of cervical spine levels for treatment) and a neurological examination. Following screening, eligible subjects will be randomised by an online randomisation system in a 1:1 ratio to treatment with either laminectomy alone or laminectomy and fusion. They will then be given a unique trial ID number. Each patient has the right to withdraw from the trial at any time. The following baseline assessments will then take place: weight (kg), smoking status, psychiatric comorbidities, impaired gait, medical history (comorbidities), medication history, mJOA assessment, SF36v2 (quality of life) score (physical component score and mental component score), EQ5D-5L, patient health questionnaire (PHQ9), Generalised Anxiety Disorder Questionnaire (GAD7), Neck Disability Index (NDI), Brief Pain Inventory (BPI), Douleur Neuropathique 4 (DN4), Michigan Body Map (pain location), cervical x-rays (deformity, auto-fusion, movement), Myelopathy.org symptom inventory, (Updated) Charleston Comorbidity Index, healthcare resource use questionnaire. The following intraoperative assessments will take place when the patient undergoes their surgical treatment: operation title, levels treated, American Society Anaesthesiology (ASA) grade, operation duration, estimated blood loss, intraoperative complications, use of intraoperative navigation or intraoperative neuromonitoring (neurophysiology), nature of Inserted Metalwork, if applicable (number/brand) and use of synthetic products to support fusion. On discharge, the following will be assessed: length of stay and ward type, complications, other adverse events (e.g. requirement for blood transfusion) and change in medication. Postoperatively, participants are to be reviewed at 6-, 12- and 24-months post-surgery for assessments. At each of these reviews, the following will be assessed: mJOA, SF36v2 (quality of life) Score, EQ5D-5L, Neck Disability Index (NDI), Brief Pain Inventory (BPI), Douleur Neuropathique 4(DN4), Michigan Body Map (Pain Location), complications (including surgical site infection, wound breakdown, instrument failure), adverse events, cervical x-rays (deformity, fusion, movement), Myelopathy.org symptom inventory, change in medication and healthcare resource use questionnaire. Outcomes are largely centralised, and either conducted by the patient, or an assessor blinded to their trial arm. The only pre-defined requirement for local sites is to arrange the cervical spine x-rays. Additionally, participants will be informed of an option to measure CarerQOL at baseline. As a chronic disease with a significant disability, patients are often dependent to some degree on those around them, which in turn affect their carers' quality of life. Contact details will be provided should the participant, or their informal carer(s) have follow up questions for the investigator team. Informal carers consenting to participate will be sent a CarerQOL to complete at baseline, discharge from hospital, 6, 12 and 24 months after surgery. Trial participation will end 24 months post-surgery for each participant (unless consent has been given, and funding secured, for extended follow up). Following trial completion, patients will return to routine care as per their local centre protocols. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Neurological outcome measured using the Modified Japanese Orthopaedic Association score (mJOA) at 24 months |
| Secondary outcome measures | 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 |
| Overall study start date | 10/04/2020 |
| Overall study end date | 01/11/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 394; UK Sample Size: 394 |
| Participant 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 |
| Participant 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) |
| Recruitment start date | 01/03/2022 |
| Recruitment end date | 01/05/2026 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Liverpool
L9 7LJ
United Kingdom
Kayll Road
Sunderland
SR4 7TP
United Kingdom
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Herries Road
Sheffield
S5 7AU
United Kingdom
Russell Road
Ipswich
IP1 2BX
United Kingdom
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Eastern Road
Brighton
BN2 5BE
United Kingdom
2-4 Waterloo Place
Edinburgh
EH1 3EG
United Kingdom
Maes-y-coed Road
Cardiff
CF14 4HH
United Kingdom
Lancashire Enterprise Business Park
Centurion Way
Leyland
PR26 6TT
United Kingdom
London
SE5 9RS
United Kingdom
London
NW1 2PG
United Kingdom
80 Newark Street
London
E1 2ES
United Kingdom
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
Stanmore
HA7 4LP
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
Sponsor information
Hospital/treatment centre
Cambridge Biomedical Campus
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom
| Phone | +44 (0)1223 348490 |
|---|---|
| research@addenbrookes.nhs.uk | |
| Website | http://www.cuh.org.uk/ |
"ROR" |
https://ror.org/04v54gj93 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/11/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
03/03/2025: The following changes were made:
1. The overall study end date was changed from 01/11/2027 to 01/11/2028.
2. The study website was added.
3. The recruitment end date was changed from 01/11/2025 to 01/05/2026.
02/08/2023: The scientific contact's details have been changed.
09/02/2022: Trial's existence confirmed by the NIHR.
