Clinical trial NCT06639334: The Q-REDUCE Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: THA
Dislocation, Hip
PROM
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: University Hospital of Southern Denmark
First posted: 2024-10-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

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