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Not yet recruiting NCT06639334

The Q-REDUCE Study

No phase Interventional THA Dislocation, Hip PROM

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fasttrack pathway for THA/HE prosthesis reduction, Standard pathway for THA/HE prosthesis reduction.
Who it may be relevant to
Registry conditions: THA, Dislocation, Hip, PROM. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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

Interventions

  • Other 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.
  • Other 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.

Primary outcome measures

  • Time from arrival at the emergency entrance to prosthesis reduction [Time frame: 1 year]
Secondary outcome measures (11)
  • Total hospitalization time from arrival to discharge [Time frame: 1 year]
  • Intra-operative complications (fracture, unsuccessful reduction, aspiration, need for mask ventilation and/or intubation, others) [Time frame: 1 year]
  • Post-operative complications (cardiac, pulmonal, thrombo-embolic events, nerve damage, re-dislocation, others) during hospitalization [Time frame: 1 year]
  • 30 days re-admission [Time frame: 30 days]
  • 30- and 90-days mortality [Time frame: 30 and 90 days]
  • Hip-related pain measured by a 10-digit numeric rating scale (NRS) [Time frame: Day 0, 1, 3, 7, 14 and 30]
  • Patient-reported outcome (PRO) using the Hip disability and Osteoarthritis Outcome Score (HOOS), [Time frame: Day 0, 14, 90, 180 and 365]
  • Health-related quality of life using the EQ-5D questionnaire [Time frame: Day 0, 14, 90, 180 and 365]
  • Patient satisfaction [Time frame: During hospital admission, day 1.]
  • Time consumption by the involved staff (orthopedic, anesthetic, radiology staff etc.) [Time frame: 1 year]
  • Total hospital costs during admission [Time frame: 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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

Identifiers

NCT: NCT06639334 · 24/34681

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗