The Q-REDUCE Study

NCT06639334 | Not Yet Recruiting

• 1 other identifier: 24/34681
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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

Conditions

THA; Dislocation, Hip; PROM

Outcome Measures

Primary Outcomes (1)

• Time from arrival at the emergency entrance to prosthesis reduction

  1 year

Secondary Outcomes (11)

• 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

Study Arms (2)

Standard treatment

ACTIVE COMPARATOR

Standard pathway for THA/HE reduction

Other: Standard pathway for THA/HE prosthesis reduction

Fast-track treatment

EXPERIMENTAL

Fasttrack pathway for THA/HE reduction

Other: Fasttrack pathway for THA/HE prosthesis reduction

Interventions

Fasttrack pathway for THA/HE prosthesis reduction 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.

Fast-track treatment

Standard pathway for THA/HE prosthesis reduction 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.

Standard treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Denmark: lead
• University Hospital of Southern Denmark: collaborator

Related Publications (1)

• Eggers Rasmussen L, Forberg Almas T, Kuhne-Qvist PJ, Beese Dalby R, Biesenbach P, Lykke Hermansen L. Quick pathway for patients with high pRobability of dislocatEd hemiarthroplasty or total hip arthroplasty to minimise the time from hospital aDmission to redUCtion of the prosthesis (Q-REDUCE): protocol for a prospective cohort study. BMJ Open. 2025 Jul 7;15(7):e091791. doi: 10.1136/bmjopen-2024-091791.

  PMID: 40623887 DERIVED

MeSH Terms

Conditions

Hip Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: October 15, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share