The Q-REDUCE Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2027-08-31

Brief Summary

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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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Detailed Description

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Conditions

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THA Dislocation, Hip PROM

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard treatment

Standard pathway for THA/HE reduction

Group Type ACTIVE_COMPARATOR

Standard pathway for THA/HE prosthesis reduction

Intervention Type 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.

Fast-track treatment

Fasttrack pathway for THA/HE reduction

Group Type EXPERIMENTAL

Fasttrack pathway for THA/HE prosthesis reduction

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No