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Surgical Recovery Support Pillow for Spine Surgeries

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 31 days later Oct 2026 → Dec 2026
See other at-risk trials from Montefiore Medical Center

Record History

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  1. Primary and study completion pushed from Oct 2026 to Dec 2026
  2. Primary and study completion dates: Sep 30, 2026 to Oct 2026 Show 4 more changesShow less
    • Start date changed from estimate of Aug 10, 2026 to Sep 5, 2026
    • Secondary endpoints: details revised at 1 of 1 entry
    • Publications: details revised at 2 of 2 entries
    • Eligibility criteria expanded, about 2 words
  3. Primary and study completion dates: Sep 1, 2026 to Sep 30, 2026
    • Start date: Jul 2026 to Aug 10, 2026
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07720856
Lead Sponsor Montefiore Medical Center
Conditions
(from sponsor)		 Spine Surgery Complications, Infection
Related terms Infections
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov