Can Prophylactic Foraminotomy Prevent C5 Palsy

NCT03023696 | Recruiting

• 1 other identifier: 16-353
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

C5 palsy (C5P) is a well-known, although rare complication of cervical spine decompression surgery. In severe forms, C5P causes debilitating upper extremity weakness involving the deltoids and/or biceps brachii muscles, ultimately diminishing these patients' quality of life. Furthermore, about half of patients with C5P present with sensory deficits and/or intractable pain in addition to the muscle weakness. Prophylactic bilateral foraminotomy at the C5 level during cervical decompression surgery has been studied recently with the hope that it will minimize the risk of developing a C5 nerve root palsy postoperatively. Although the current literature provides some support for this claim, there are insufficient data establishing this technique as a proven measure to reduce the incidence of C5P. In the present study, we seek to evaluate the effect of bilateral foraminotomy on postoperative C5P incidence rates. Bilateral foraminotomy has been correlated with a reduced risk of developing C5P following cervical decompression surgery, but an identical foraminotomy procedure has never been applied in a randomized manner to all qualifying patients in a study. Additionally, prophylactic foraminotomy has only been prospectively studied during laminoplasty. In the proposed study, bilateral foraminotomy will be randomized to patients receiving cervical decompression surgery (laminoplasty, laminectomy, fusion). This is a multicenter randomized trial, including the following sites: Cleveland Clinic, Columbia University Medical Center, and University of Southern California Spine Center. Patients undergoing cervical decompression surgery will be consented and enrolled if they meet the inclusion and exclusion criteria. Subsequently, incidence of C5P will be monitored to determine efficacy of prophylactic C5 bilateral foraminotomy during cervical decompression.

Conditions

Myelopathy, Compressive; Radiculopathy, Cervical; C5 Palsy

Keywords

C5 Palsy; foraminotomy

Outcome Measures

Primary Outcomes (1)

• C5 Palsy

  Using manual muscle testing and upper extremity sensory exam findings to determine C5 palsy status. C5P is defined as: a reduction of at least 1 in deltoid and/or biceps brachii manual muscle testing scores compared to preoperative scores, without any deterioration of myelopathic symptoms.

  Upon discharge, 2 weeks postoperatively and 3 months postoperatively

Secondary Outcomes (7)

• Preoperative anatomic measurements

  Preoperative

• Operative time

  Intra-operative measurement

• Blood loss

  Intra-operative measurement

• Back Pain

  Preoperative, 2 weeks postoperative and 3 months postoperative

• Leg Pain

  Preoperative, 2 weeks postoperative and 3 months postoperative

Study Arms (2)

Foraminotomy Group

EXPERIMENTAL

Prophylactic bilateral cervical keyhole foraminotomy will be done in addition to their decompression surgery

Procedure: Bilateral Cervical Keyhole Foraminotomy; Procedure: Cervical Decompression

Control Group

ACTIVE COMPARATOR

Cervical decompression will be done without prophylactic bilateral foraminotomy

Procedure: Cervical Decompression

Interventions

Cervical Decompression PROCEDURE

Cervical decompression for myelopathy, including the following procedures: laminoplasty, laminectomy, discectomy and fusion

Control Group; Foraminotomy Group

Bilateral Cervical Keyhole Foraminotomy PROCEDURE

Under microscopic or loop magnification, a high-speed burr is used to perform the foraminotomy. The keyhole foraminotomy begins at the lamina-facet junction, with careful consideration of the amount of facet resection. Typically, only the medial one third is drilled. Then a 1- or 2-mm Kerrison punch can be carefully placed over the nerve root and then used to undercut the facet, ensuring that the spine is not destabilized by the foraminotomy. The amount of facet resection must not exceed 50% in order to preserve spine stability.

Foraminotomy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cleveland Clinic patients who have been diagnosed with cervical myelopathy, without radiculopathy, and will undergo posterior cervical decompression involving the C4-C5 interspace between 2016 and 2018. This includes patients undergoing cervical laminoplasty and cervical laminectomy and fusion.

You may not qualify if:

• Any patient younger than 18 years of age will not be included on the basis of skeletal immaturity. Patients with C5 radiculopathy - defined in our study as the existence of preoperative deltoid muscle weakness in grade 3 or less by MMT - will be excluded. Any patients who have undergone previous cervical spine surgery, or who have any spinal malignancy, trauma or infection will be excluded in order to eliminate the confounding effect of multiple surgical interventions.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Related Publications (8)

• Wada E, Suzuki S, Kanazawa A, Matsuoka T, Miyamoto S, Yonenobu K. Subtotal corpectomy versus laminoplasty for multilevel cervical spondylotic myelopathy: a long-term follow-up study over 10 years. Spine (Phila Pa 1976). 2001 Jul 1;26(13):1443-7; discussion 1448. doi: 10.1097/00007632-200107010-00011.

  PMID: 11458148 BACKGROUND

• Epstein NE, Hollingsworth R. C5 Nerve root palsies following cervical spine surgery: A review. Surg Neurol Int. 2015 May 7;6(Suppl 4):S154-63. doi: 10.4103/2152-7806.156556. eCollection 2015.

  PMID: 26005577 BACKGROUND

• Miller JA, Lubelski D, Alvin MD, Benzel EC, Mroz TE. C5 palsy after posterior cervical decompression and fusion: cost and quality-of-life implications. Spine J. 2014 Dec 1;14(12):2854-60. doi: 10.1016/j.spinee.2014.03.038. Epub 2014 Apr 3.

  PMID: 24704502 BACKGROUND

• Sakaura H, Hosono N, Mukai Y, Ishii T, Yoshikawa H. C5 palsy after decompression surgery for cervical myelopathy: review of the literature. Spine (Phila Pa 1976). 2003 Nov 1;28(21):2447-51. doi: 10.1097/01.BRS.0000090833.96168.3F.

  PMID: 14595162 BACKGROUND

• Katsumi K, Yamazaki A, Watanabe K, Ohashi M, Shoji H. Can prophylactic bilateral C4/C5 foraminotomy prevent postoperative C5 palsy after open-door laminoplasty?: a prospective study. Spine (Phila Pa 1976). 2012 Apr 20;37(9):748-54. doi: 10.1097/BRS.0b013e3182326957.

  PMID: 21912316 BACKGROUND

• Komagata M, Nishiyama M, Endo K, Ikegami H, Tanaka S, Imakiire A. Prophylaxis of C5 palsy after cervical expansive laminoplasty by bilateral partial foraminotomy. Spine J. 2004 Nov-Dec;4(6):650-5. doi: 10.1016/j.spinee.2004.03.022.

  PMID: 15541697 BACKGROUND

• Sasai K, Saito T, Akagi S, Kato I, Ohnari H, Iida H. Preventing C5 palsy after laminoplasty. Spine (Phila Pa 1976). 2003 Sep 1;28(17):1972-7. doi: 10.1097/01.BRS.0000083237.94535.46.

  PMID: 12973145 BACKGROUND

• Lubelski D, Derakhshan A, Nowacki AS, Wang JC, Steinmetz MP, Benzel EC, Mroz TE. Predicting C5 palsy via the use of preoperative anatomic measurements. Spine J. 2014 Sep 1;14(9):1895-901. doi: 10.1016/j.spinee.2013.10.038. Epub 2013 Nov 10.

  PMID: 24225009 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Compression; Radiculopathy

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Injuries; Wounds and Injuries; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Thomas E Mroz, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nya Robinson

CONTACT

2164441741; ROBINSN8@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Institute Chair

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 18, 2017
• Study Start: June 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)