Surgical Recovery Support Pillow for Spine Surgeries

NCT07720856 | Recruiting FDA Device

• 1 other identifier: 2026-17746
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The present study investigates the feasibility of a support pillow for use after spinal surgical procedures, and more particularly, to protect the midline region of the back following spinal surgery. Existing cushioning pillows do not accommodate the anatomy of the human back nor the requirements of isolating a vertical spinal incision. For example, donut-style or ring-shaped pillows are designed for entirely different purposes, such as hemorrhoidal relief, and cannot provide the desired spinal relief. As a result, there is no suitable, dedicated support structure that allows a patient to rest on their back while eliminating pressure on the surgical site. Accordingly, there is a need for a device that permits postoperative spinal surgery patients to sit or lie in a supine or reclined position without the surgical incision contacting or being compressed by any supporting surface.

Conditions

Spine Surgery Complications; Infection

Keywords

Post-surgical pillow

Outcome Measures

Primary Outcomes (1)

• Pillow use

  Pillow use will be measured as a dichotomous measure of whether or not the pillow was used. Results will be summarized.

  One day after surgery, on discharge day (approximately 1-3 days after surgery) and 2 weeks after surgery

Secondary Outcomes (1)

• Pillow comfort and pain

  One day after surgery, at discharge (approximately 1- 3 days after surgery) and 2 weeks after surgery

Other Outcomes (1)

• Frequency of pillow usage

  One day after surgery, on discharge day (approximately 1-3 days after surgery) and 2 weeks after surgery

Study Arms (1)

Participant

EXPERIMENTAL

Surgical Recovery Support Pillow

Device: Surgical Recovery Support Pillow

Interventions

Surgical Recovery Support Pillow DEVICE

The Surgical Recovery Support Pillow for Spine Surgeries is a pillow with an open space in the middle in the shape of the spine. The space can accommodate the healing of the surgical site wound by minimizing friction between pillow and spinal wound which can lead to disruption of the sutures and infections. In contrast, normal pillows do not have a central open space in the shape of the spine, and does not minimize the wound friction.

Participant

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients who have lumbar fusion surgery, who consent to participate

You may not qualify if:

• Pediatric patients 18 years old and under

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

RECRUITING

Related Publications (2)

• Ghobrial GM, Harrop JS, Sasso RC, Tannoury CA, Tannoury T, Smith ZA, Hsu WK, Arnold PM, Fehlings MG, Mroz TE, De Giacomo AF, Jobse BC, Rahman RK, Thompson SE, Riew KD. Anterior Cervical Infection: Presentation and Incidence of an Uncommon Postoperative Complication. Global Spine J. 2017 Apr;7(1 Suppl):12S-16S. doi: 10.1177/2192568216687546. Epub 2017 Apr 1.

  PMID: 28451485 BACKGROUND

• Chaichana KL, Bydon M, Santiago-Dieppa DR, Hwang L, McLoughlin G, Sciubba DM, Wolinsky JP, Bydon A, Gokaslan ZL, Witham T. Risk of infection following posterior instrumented lumbar fusion for degenerative spine disease in 817 consecutive cases. J Neurosurg Spine. 2014 Jan;20(1):45-52. doi: 10.3171/2013.10.SPINE1364. Epub 2013 Nov 8.

  PMID: 24206038 BACKGROUND

MeSH Terms

Conditions

Infections

Study Officials

• Ananth Eleswarapu, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela C Zuckerman, PhD

CONTACT

13479201340; pcabahugzu@montefiore.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will use the Surgical Recovery Support Pillow instead of a regular pillow during their recovery following spine surgery.

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: July 22, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)