The Q-REDUCE Study

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

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 Overview

• Status: Not yet recruiting
• Conditions: Dislocation, Hip; PROM; THA
• Intervention / Treatment: Other: Standard pathway for THA/HE prosthesis reduction; Other: Fasttrack pathway for THA/HE prosthesis reduction

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard treatment; Standard pathway for THA/HE reduction	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.
Experimental: Fast-track treatment; Fasttrack pathway for THA/HE reduction	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time from arrival at the emergency entrance to prosthesis reduction	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total hospitalization time from arrival to discharge		1 year
Intra-operative complications (fracture, unsuccessful reduction, aspiration, need for mask ventilation and/or intubation, others)		1 year
Post-operative complications (cardiac, pulmonal, thrombo-embolic events, nerve damage, re-dislocation, others) during hospitalization		1 year
30 days re-admission		30 days
30- and 90-days mortality		30 and 90 days
Hip-related pain measured by a 10-digit numeric rating scale (NRS)	Evaluated from 1 (best) to 10 (worst).	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).	Day 0, 14, 90, 180 and 365
Health-related quality of life using the EQ-5D questionnaire		Day 0, 14, 90, 180 and 365
Patient satisfaction	Consists of four self-developed questions.	During hospital admission, day 1.
Time consumption by the involved staff (orthopedic, anesthetic, radiology staff etc.)		1 year
Total hospital costs during admission		1 year

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: University Hospital of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Hip Injuries; Joint Dislocations; Hip Dislocation; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Parasympathomimetics; Tacrine
• Other Study ID Numbers: 24/34681

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No