Recruiting

Prophylactic Foraminotomy

Sponsor:

The Cleveland Clinic

Code:

NCT03023696

Conditions

Myelopathy, Compressive

Radiculopathy, Cervical

C5 Palsy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bilateral Cervical Keyhole Foraminotomy

Cervical Decompression

Study Details

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

Study ID

NCT03023696

Start date

Jun, 2016

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

480 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Foraminotomy Group

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

active comparator: Control Group

Cervical decompression will be done without prophylactic bilateral foraminotomy

Interventions

Bilateral Cervical Keyhole Foraminotomy

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.

Cervical Decompression

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

Primary outcome measure

  • C5 Palsy [ Time Frame: Upon discharge, 2 weeks postoperatively and 3 months postoperatively ]

Central Contacts and Locations

Central contacts

Locations

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Emily Fisher, MPH

fishere3@ccf.org

More Information

Sponsor

The Cleveland Clinic

Last update posted

Jan 22, 2026

Last verified

Jan, 2026

Keywords

  • C5 Palsy
  • foraminotomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-01-22.