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NCT Number: NCT06639334

The Q-REDUCE Study

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

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Key information

Conditions

THA Dislocation, Hip Hip Dislocation Hip Injuries Joint Diseases Joint Dislocations Musculoskeletal Diseases PROM Wounds and Injuries

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fasttrack pathway for THA/HE prosthesis reduction

Other

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.

Standard pathway for THA/HE prosthesis reduction

Other

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 outcomes

  1. Time from arrival at the emergency entrance to prosthesis reduction

    Time frame: 1 year

Secondary outcomes

  1. Total hospitalization time from arrival to discharge

    Time frame: 1 year

  2. Intra-operative complications (fracture, unsuccessful reduction, aspiration, need for mask ventilation and/or intubation, others)

    Time frame: 1 year

  3. Post-operative complications (cardiac, pulmonal, thrombo-embolic events, nerve damage, re-dislocation, others) during hospitalization

    Time frame: 1 year

  4. 30 days re-admission

    Time frame: 30 days

  5. 30- and 90-days mortality

    Time frame: 30 and 90 days

  6. Hip-related pain measured by a 10-digit numeric rating scale (NRS)

    Time frame: Day 0, 1, 3, 7, 14 and 30

    Evaluated from 1 (best) to 10 (worst).

  7. Patient-reported outcome (PRO) using the Hip disability and Osteoarthritis Outcome Score (HOOS),

    Time frame: Day 0, 14, 90, 180 and 365

    Evaluated from 0 (worst) to 100 (best).

  8. Health-related quality of life using the EQ-5D questionnaire

    Time frame: Day 0, 14, 90, 180 and 365

  9. Patient satisfaction

    Time frame: During hospital admission, day 1.

    Consists of four self-developed questions.

  10. Time consumption by the involved staff (orthopedic, anesthetic, radiology staff etc.)

    Time frame: 1 year

  11. Total hospital costs during admission

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Esbjerg Hospital - University Hospital of Southern Denmark

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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