UMIN-ICDS Clinical Trial

Public title

A prospective randomized trial of cervical collar use after anterior cervical discectomy and fusion using ROI-C

Acronym

ROI-C Collar Trial

Scientific Title

A Prospective Randomized Controlled Trial Evaluating the Necessity of Postoperative Cervical Collar Use After Anterior Cervical Fusion Using ROI-C, With Early Postoperative Neck Disability Index as the Primary Outcome

Scientific Title:Acronym

ROI-C Collar Trial

Region

Japan

Condition

Degenerative cervical myelopathy and/or radiculopathy (primarily including cervical spondylotic radiculopathy, cervical spondylotic amyotrophy, cervical spondylotic myelopathy, cervical ossification of the posterior longitudinal ligament, and cervical disc herniation).

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare the effect of wearing a Philadelphia cervical collar for 6 weeks versus no routine cervical collar on early postoperative neck disability after one- or two-level anterior cervical discectomy and fusion (ACDF) using ROI-C. The primary endpoint is the Neck Disability Index (NDI, 0-50 points) at 6 weeks postoperatively.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

The Neck Disability Index (NDI) at 6 weeks after anterior cervical fusion using ROI-C will be compared between the cervical collar group and the non-collar group. A standard Philadelphia cervical collar will be used for postoperative immobilization. The NDI is scored on a scale from 0 to 50, with higher scores indicating greater neck-related functional disability.

Key secondary outcomes

1. Changes in the Neck Disability Index (NDI) preoperatively and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months postoperatively
2. Neck pain visual analog scale (VAS; average pain during the previous 7 days, 0-100 mm) measured preoperatively and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months postoperatively
3. Japanese Orthopaedic Association (JOA) score, Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ), EQ-5D, SF-8, and patient satisfaction measured preoperatively and at 3 months, 6 months, and 12 months postoperatively
4. Radiographic parameters including C2-7 lordotic angle, T1 slope, C2-7 sagittal vertical axis (C2-7 SVA), and C2-7 range of motion (C2-7 ROM)
5. Cage subsidence (change in intervertebral height from immediately after surgery to 3 and 6 months postoperatively)
6. Fusion status at 12 months evaluated using plain radiographs and/or computed tomography
7. Wound findings and wound-related complications, including surgical site infection (SSI), hematoma, seroma, wound dehiscence, and reoperation
8. Dysphagia, hoarseness, collar-related skin problems (redness, pressure marks, pressure ulcer), collar-related discomfort, and other adverse events

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Group A (cervical collar group): After one- or two-level ACDF using ROI-C, patients will wear a standard Philadelphia cervical collar for 6 weeks postoperatively. ROI-C manufactured by Highridge Medical will be used as the stand-alone cervical fixation device, without an additional anterior plate. Surgical approach (left transverse cervical incision), wound closure, drain use, analgesia, mobilization, rehabilitation, and other perioperative management will be standardized between groups as much as possible.

Interventions/Control_2

Group B (no cervical collar group): After one- or two-level ACDF using ROI-C, patients will not routinely wear a cervical collar postoperatively. ROI-C manufactured by Highridge Medical will be used as the stand-alone cervical fixation device, without an additional anterior plate. Surgical approach, wound closure, drain use, analgesia, mobilization, rehabilitation, and other perioperative management will be standardized between groups as much as possible. If the attending physician judges that collar use is necessary for safety or clinical reasons, cervical collar use will be allowed and recorded as a post-randomization management change.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients scheduled to undergo elective anterior cervical discectomy and fusion (ACDF) using ROI-C at our institution
2. Age >=20 years
3. Patients with one- or two-level degenerative cervical myelopathy and/or cervical radiculopathy (mainly cervical spondylotic radiculopathy, cervical spondylotic amyotrophy, cervical spondylotic myelopathy, ossification of the posterior longitudinal ligament, cervical disc herniation, etc.) who are deemed suitable for anterior cervical fusion
4. Patients who have provided written informed consent

Key exclusion criteria

1. Revision surgery cases
2. Patients whose primary pathology is non-degenerative disease, such as infection, tumor, or trauma
3. Fusion involving three or more levels
4. Patients judged unsuitable for study participation by the operating surgeon because of poor bone quality or other clinical reasons

Target sample size

56

Name of lead principal investigator

1st name	Shota
Middle name
Last name	Takenaka

Organization

Japan Community Healthcare Organization Osaka Hospital

Division name

Department of orthopaedic surgery

Zip code

553-0003

Address

4-2-78 Fukushima, Fukushima-ku, Osaka City, Osaka, Japan

TEL

06-6441-5451

Email

show@yb3.so-net.ne.jp

Name of contact person

1st name	Shota
Middle name
Last name	Takenaka

Organization

Japan Community Healthcare Organization Osaka Hospital

Division name

Department of orthopaedic surgery

Zip code

553-0003

Address

4-2-78 Fukushima, Fukushima-ku, Osaka City, Osaka, Japan

TEL

06-6441-5451

Homepage URL

Email

show@yb3.so-net.ne.jp

Institute

Japan Community Healthcare Organization Osaka Hospital

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Japan Community Healthcare Organization Osaka Hospital review board

Address

4-2-78 Fukushima, Fukushima-ku, Osaka City, Osaka, Japan

Tel

06-6441-5451

Email

horimoto-takiko@osaka.jcho.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

05

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2026

Year

04

Month

26

Day

Date of IRB

2026

Year

05

Month

14

Day

Anticipated trial start date

2026

Year

05

Month

14

Day

Last follow-up date

2028

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Randomization
Patients will be allocated 1:1, stratified by the number of operated levels (1 vs 2) using variable block randomization (block sizes 4,6,8). The sequence will be generated via R. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes (SNOSE).

Common procedures
A stand-alone ROI-C (Highridge Medical) will be used without an anterior plate. The surgical approach (left transverse incision), wound closure, drain, analgesia, and rehabilitation will be standardized between groups.

Intervention
Collar group: Patients will wear a Philadelphia collar for 6 weeks.
No-collar group: A collar will not be used routinely. However, collar use is allowed if the attending physician deems it necessary for safety/clinical reasons; such cases will be recorded as management changes.

Imaging
Only routine clinical images (X-ray, CT) will be used; no research-specific imaging will be performed. Assessors will be blinded to allocation whenever possible.

Analysis
The primary analysis will be ITT-based. Between-group differences in 6-week NDI will be estimated via ANCOVA, adjusting for baseline NDI. Sensitivity analyses will include adjustment for operated levels and per-protocol analysis. Mixed-effects models will be used for repeated measures, and chi-square or Fisher's exact tests for binary outcomes.

Adverse events
Data on SSI, hematoma, seroma, wound dehiscence, dysphagia, hoarseness, and collar-related skin problems/discomfort will be collected. Post-randomization changes in collar use will be recorded and analyzed according to the ITT principle.

Registered date

2026

Year

05

Month

14

Day

Last modified on

2026

Year

05

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070329