The Q-REDUCE Study

N/ANot Yet RecruitingNCT06639334

University of Southern Denmark120 enrolled

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

THA Dislocation, Hip PROM

Interventions

Fasttrack pathway for THA/HE prosthesis reductionOTHER

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 reductionOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Time from arrival at the emergency entrance to prosthesis reduction

Time frame: 1 year

Secondary Outcomes

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)

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

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

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

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

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

Consists of four self-developed questions.

Data from ClinicalTrials.gov

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