[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07720856":3,"trial-entities:NCT07720856":94,"trial-summary:NCT07720856":98},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":9,"sponsor_name":11,"lead_sponsor_class":12,"has_dmc":13,"brief_summary":14,"detailed_description":15,"conditions":16,"keywords":19,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":40,"sex":45,"minimum_age":46,"maximum_age":47,"healthy_volunteers":48,"eligibility_criteria":49,"std_ages":55,"locations":58,"central_contacts":80,"overall_officials":83,"references":85,"see_also_links":93},"NCT07720856","2026-17746","Surgical Recovery Support Pillow for Spine Surgeries","RECRUITING","2026-09-01","2026-07","2026-07-22","Montefiore Medical Center","OTHER",false,"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.\n\nExisting 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.","The investigators hypothesize that use of the back saver pillow as currently designed will be feasible and that patients will report subjective improvement in pain when applying the pillow. Our specific aims are two-fold, namely (1) Determine if patients are able to utilize the back saver pillow as currently designed and (2) Survey patients as to whether they feel the back saver pillow was beneficial for their recovery.\n\nOur study design is as follows. Eligible patients will be asked pre-op whether they would like to be part of this study and asked for informed consent prior to surgery. A total of 10 patients will be recruited. Enrolled patients will be provided with the back saver pillow either while admitted, if inpatient, or at the time of discharge for same-day surgery patients. Patients will be asked to fill out a survey with questions related to how easy the pillow was to use and whether they found it to reduce their pain on the rating scale of 1-10, where 1 is no pain and 10 is most painful. There will be 3 survey timepoints post-surgery: (1) on the day following surgery, (2) right before discharge and (3) 2-weeks post-surgery. Surveys will assess patient feedback about ease of use, and pain, first without the pillow in the supine position and sitting up with the back against another surface, then with the pillow in the supine position and sitting up with the back against another surface.",[17,18],"Spine Surgery Complications","Infection",[20],"Post-surgical pillow","INTERVENTIONAL","SUPPORTIVE_CARE",[24],"NA",{"count":26,"type":27},10,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DEVICE","Surgical Recovery Support Pillow","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.",[34],"Participant",[36],{"measure":37,"description":38,"timeFrame":39},"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",[41],{"measure":42,"description":43,"timeFrame":44},"Pillow comfort and pain","Pillow comfort and pain will be assessed as a single composite measure on a scale from 1 to 10, with 1 being very little pain and 10 being extremely painful, such that higher scores are indicative of increased pain. Assessments will be made both without the back saver pillow - in both the supine position and sitting up with back against another surface, and with the back saver pillow - in both the supine position and sitting up with back against another surface. Results for each combination of pillow set up will be summarized using descriptive statistics.","One day after surgery, at discharge (approximately 1- 3 days after surgery) and 2 weeks after surgery","ALL","19 Years",null,true,{"inclusion":50,"exclusion":52,"raw_text":54},[51],"Adult patients who have lumbar fusion surgery, who consent to participate",[53],"Pediatric patients 18 years old and under","Inclusion Criteria:\n\n* Adult patients who have lumbar fusion surgery, who consent to participate\n\nExclusion Criteria:\n\n* Pediatric patients 18 years old and under",[56,57],"ADULT","OLDER_ADULT",[59],{"facility":11,"status":7,"city":60,"state":61,"zip":62,"country":63,"contacts":64,"geoPoint":77},"The Bronx","New York","10461","United States",[65,70,74],{"name":66,"role":67,"phone":68,"email":69},"Ananth C Eleswarapu, MD","CONTACT","718-920-2060","aeleswarap@montefiore.org",{"name":71,"role":67,"phone":72,"email":73},"Pamela C Zuckerman, PhD","347-920-1340","pcabahugzu@montefiore.org",{"name":75,"role":76},"Ananth Eleswarapu, MD","PRINCIPAL_INVESTIGATOR",{"lat":78,"lon":79},40.84985,-73.86641,[81],{"name":71,"role":67,"phone":82,"email":73},"13479201340",[84],{"name":75,"affiliation":11,"role":76},[86,90],{"pmid":87,"type":88,"citation":89},"28451485","BACKGROUND","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\u002F2192568216687546. Epub 2017 Apr 1.",{"pmid":91,"type":88,"citation":92},"24206038","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\u002F2013.10.SPINE1364. Epub 2013 Nov 8.",[],{"nct_id":4,"conditions":95,"biomarkers":97},[96],"Spine Surgery",[],{"nct_id":4,"found":48,"summary":99,"prompt_version":108},{"design":100,"status":101,"heading":6,"summary":102,"follow_up":103,"word_count":104,"commitments":105,"compensation":106,"drugs_mentioned":107},"This is an interventional study with a planned enrollment of 10 adult patients. It is a single-arm study, meaning all participants will receive the Surgical Recovery Support Pillow.","completed","This study is looking at a special pillow called the Surgical Recovery Support Pillow for Spine Surgeries. This pillow has an open space in the middle to protect the surgical wound on your back after spine surgery, aiming to reduce friction and potential complications like infection. Researchers want to see if this pillow is easy for patients to use and if it helps reduce pain during recovery. You might be able to join if you are an adult having lumbar fusion surgery. The study will measure how often the pillow is used and how much it helps with pain at one day, at discharge, and two weeks after surgery.","Participants will be followed for two weeks after surgery, with surveys at one day, at discharge, and at the two-week mark.",109,"You would be asked to use the Surgical Recovery Support Pillow and complete surveys about its ease of use and pain reduction. These surveys will be done one day after surgery, at discharge, and two weeks after surgery.","Not stated in the trial record.",[31],"v2"]