The Q-REDUCE Study

Официальное название

A Quick Pathway for Patients With High pRobability of dislocatEd Hemi- or Total Hip Arthroplasty to Minimize the Time From Hospital aDmission to redUCtion of the prosthEsis

Обзор

The purpose of this study is to design a fast-track pathway for patients referred to the University Hospital of Southern Denmark, Esbjerg, with high probability of having a dislocated hip prosthesis with the primary aim to reduce the time from arrival to reduction and the total hospitalization time. Secondary aims are to * investigate whether quicker prosthesis reduction influences on hip function and quality of life afterwards * reduce the pain experience immediately and in the long term * increase patient satisfaction without changing the overall complication rate and readmission/mortality

Вмешательства

• Другое Fasttrack pathway for THA/HE prosthesis reduction
  The purpose of this study is to design a fast-track pathway for patients referred to the University Hospital of Southern Denmark, Esbjerg, with high probability of having a dislocated hip prosthesis with the primary aim to reduce the time from arrival to reduction and the total hospitalization time. The intervention is changed logistic and work pathways at the hospital that should reduce time to reduction significantly. For detailed description we refer to the uploaded protocol.
• Другое Standard pathway for THA/HE prosthesis reduction
  Standard treatment for a dislocated THA/HA at our institution is education in general anesthesia at the operating theater. For detailed description we refer to the uploaded protocol.

Первичные конечные точки

• Time from arrival at the emergency entrance to prosthesis reduction [Срок оценки: 1 year]

Вторичные конечные точки (11)

• Total hospitalization time from arrival to discharge [Срок оценки: 1 year]
• Intra-operative complications (fracture, unsuccessful reduction, aspiration, need for mask ventilation and/or intubation, others) [Срок оценки: 1 year]
• Post-operative complications (cardiac, pulmonal, thrombo-embolic events, nerve damage, re-dislocation, others) during hospitalization [Срок оценки: 1 year]
• 30 days re-admission [Срок оценки: 30 days]
• 30- and 90-days mortality [Срок оценки: 30 and 90 days]
• Hip-related pain measured by a 10-digit numeric rating scale (NRS) [Срок оценки: Day 0, 1, 3, 7, 14 and 30]
• Patient-reported outcome (PRO) using the Hip disability and Osteoarthritis Outcome Score (HOOS), [Срок оценки: Day 0, 14, 90, 180 and 365]
• Health-related quality of life using the EQ-5D questionnaire [Срок оценки: Day 0, 14, 90, 180 and 365]
• Patient satisfaction [Срок оценки: During hospital admission, day 1.]
• Time consumption by the involved staff (orthopedic, anesthetic, radiology staff etc.) [Срок оценки: 1 year]
• Total hospital costs during admission [Срок оценки: 1 year]

Критерии участия

Критерии включения

• a history of either a THA or a HA in combination with at least one of the following terms
• having sustained a sudden, incorrect movement or twist in the hip joint in either a bending, sitting or supine position leading to inability to stand or walk
• misalignment of the concerned lower extremity (typically shortened, with inward/outward rotation)

Критерии исключения

• recurrent dislocations during the same hospital admission (already "in the house")
• anticipated difficult airway by the attending anesthesiologist
• anticipated need for extended respiratory or hemodynamic monitoring by the attending anesthesiologist
• American Society of Anesthesiologists (ASA) score > 3
• Body Mass Index (BMI) > 40
• active drug abuse
• contraindication for Propofol or Esketamine

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Eggers Rasmussen L, Forberg Almas T, Kuhne-Qvist PJ, Beese Dalby R, Biesenbach P, Lykke Hermansen L. Quick pathway for patients with high pRobability of dislocatEd hemiarthroplasty or total hip arthroplasty to minimise the time from hospital aDmission to redUCtion of the prosthesis (Q-REDUCE): protocol for a prospective cohort study. BMJ Open. 2025 Jul 7;15(7):e091791. doi: 10.1136/bmjopen-2024-09 PMID 40623887

Идентификаторы

NCT: NCT06639334 · 24/34681

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗