Can prophylactic bilateral C4/C5 foraminotomy prevent postoperative C5 palsy after open-door laminoplasty?: a prospective study.
Keiichi Katsumi, Akiyoshi Yamazaki, Kei Watanabe...
https://pubmed.ncbi.nlm.nih.gov/21912316/Actively Recruiting
Led by The Cleveland Clinic · Updated on 2026-01-22
480
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are investigating C5 palsy C5P, a rare but serious complication that can occur after cervical spine decompression surgery. This condition causes weakness in certain shoulder and arm muscles and may also lead to sensory problems and pain, reducing patients quality of life. The study aims to evaluate whether performing a preventive bilateral foraminotomy at the C5 level during surgery can reduce the chance of developing C5P, as current evidence is suggestive but not conclusive. This trial is a randomized, prospective, multicenter study including patients undergoing various types of cervical decompression surgery such as laminoplasty, laminectomy, and fusion. Participants will be randomized to receive either standard cervical decompression surgery alone or decompression plus a prophylactic bilateral cervical keyhole foraminotomy. The foraminotomy procedure uses microscopic tools to carefully enlarge the nerve root exit area while preserving spine stability by limiting facet bone removal. The study will monitor the incidence of postoperative C5 palsy and other surgical outcomes. This approach is being assessed across multiple respected medical centers to determine its effectiveness and safety. During the study, participants will undergo evaluations including manual muscle testing before and after surgery to detect any muscle weakness. Researchers will collect clinical data such as operative time, blood loss, pain levels, hospital readmissions, and emergency visits. Anatomical measurements from imaging studies will also be analyzed. Follow-up assessments will occur at discharge, 2 weeks, and 3 months after surgery to track nerve function and recovery. The total study duration includes surgery and postoperative monitoring, ensuring comprehensive evaluation of the procedures impact on C5 palsy rates.
CONDITIONS
Can Prophylactic Foraminotomy Prevent C5 Palsy
N
Nya Robinson
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The Cleveland Clinic
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Foraminotomy plus standard decompression | Standard decompression alone |
|---|---|---|
| What it is | Prophylactic bilateral cervical keyhole foraminotomy performed in addition to standard posterior cervical decompression (laminoplasty or laminectomy/fusion) at C4-C5, with careful preservation of spinal stability. | Standard posterior cervical decompression (laminoplasty or laminectomy/fusion) at C4-C5, with no prophylactic foraminotomy performed. |
| Role in study | Investigational arm designed to test if adding prophylactic foraminotomy reduces the risk of postoperative C5 palsy. | Comparator arm representing routine standard surgical practice for posterior cervical decompression without added foraminotomy. |
| Main clinical use or purpose | Investigated for the prevention of C5 nerve root palsy after surgical decompression for cervical myelopathy. | Standard decompression provides relief from cervical myelopathy symptoms through removal of spinal cord compression; does not specifically address C5 palsy risk beyond routine care. |
| How it is performed | Foraminotomy is performed under magnification, with bone removal at the lamina-facet junction using a burr and punch, limited to preserve facet stability. Standard decompression is performed at the same time. | Standard decompression involves either laminoplasty or laminectomy/fusion without prophylactic foraminotomy at C4-C5. |
| Evidence status | Multiple small prospective and retrospective studies, including open-label or quasi-randomized trials, suggest prophylactic bilateral foraminotomy may reduce C5 palsy incidence after decompression, though evidence remains limited and consists mainly of single-center or non-randomized data. Definitive high-quality RCT evidence is lacking, motivating this ongoing trial. | Standard decompression effectively treats cervical myelopathy symptoms, but is associated with a small but significant risk of postoperative C5 palsy. The precise mechanism of this complication is still under study. |
| Important risks | Potential risks include excessive facet joint removal (which can threaten spine stability), nerve root injury, increased operative time, and general complications of posterior cervical spine surgery. Existing studies suggest a low added risk when performed carefully, but high-quality safety data are lacking. | Risks include C5 nerve root palsy, infection, bleeding, and instability, which are inherent to standard posterior cervical decompression procedures. Published rates of C5 palsy vary, and overall surgical risk is well recognized. |
| Important limitations | The benefit of prophylactic foraminotomy for preventing C5 palsy is supported mainly by small non-randomized studies with single-center experience and variable patient populations. Unproven for all techniques, and subject to learning-curve and technical variability across surgeons. Ongoing randomized evidence is needed to clarify benefit and safety. | Standard decompression does not specifically address the mechanism of C5 palsy and carries a persistent risk for this complication despite technical refinements. The exact causes of C5 palsy and optimal prevention methods remain uncertain. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for consent and eligibility assessment
Duration - Surgery day and hospital stay duration
Participants undergo cervical decompression surgery, with or without prophylactic bilateral cervical keyhole foraminotomy, to treat cervical myelopathy.
1 surgical visit (in-person) with hospital stay
Duration - Up to 3 months post-surgery
Participants are monitored for surgical outcomes including incidence of C5 palsy and other complications at discharge, 2 weeks, and 3 months postoperatively.
3 visits (in-person) at discharge, 2 weeks, and 3 months postoperatively
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/11458148/The Cleveland Clinic
Lead Sponsor