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The Q-REDUCE Study

University of Southern Denmark (SDU) logo

University of Southern Denmark (SDU)

Status

Not yet enrolling

Conditions

THA
PROM
Dislocation, Hip

Treatments

Other: Fasttrack pathway for THA/HE prosthesis reduction
Other: Standard pathway for THA/HE prosthesis reduction

Study type

Interventional

Funder types

Other

Identifiers

NCT06639334
24/34681

Details and patient eligibility

About

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

Enrollment

120 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

120 participants in 2 patient groups

Standard treatment
Active Comparator group
Description:
Standard pathway for THA/HE reduction
Treatment:
Other: Standard pathway for THA/HE prosthesis reduction
Fast-track treatment
Experimental group
Description:
Fasttrack pathway for THA/HE reduction
Treatment:
Other: Fasttrack pathway for THA/HE prosthesis reduction

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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