The Q-REDUCE Study

Not Applicable

Not yet recruiting

• Conditions: THA; Dislocation, Hip; PROM

• Registration Number: NCT06639334
• Lead Sponsor: University of Southern Denmark

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-29
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-10
• Last Update Submitted: 2024-10-10
• Study First Posted: 2024-10-14
• Last Update Posted: 2024-10-14
• Study Start: 2024-11-01
• Primary Completion: 2026-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Time from arrival at the emergency entrance to prosthesis reduction	1 year

Secondary Outcome Measures

Name	Time	Method
Patient-reported outcome (PRO) using the Hip disability and Osteoarthritis Outcome Score (HOOS),	Day 0, 14, 90, 180 and 365	Evaluated from 0 (worst) to 100 (best).
Health-related quality of life using the EQ-5D questionnaire	Day 0, 14, 90, 180 and 365
Patient satisfaction	During hospital admission, day 1.	Consists of four self-developed questions.
Time consumption by the involved staff (orthopedic, anesthetic, radiology staff etc.)	1 year
Total hospital costs during admission	1 year
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)	Day 0, 1, 3, 7, 14 and 30	Evaluated from 1 (best) to 10 (worst).