Health TrialsbyHealthPanel

The Q-REDUCE Study

ConditionsTHADislocation, HipPROM
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Southern Denmark

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Fasttrack pathway for THA/HE prosthesis reduction

    Other intervention

    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 reduction

    Other intervention

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Standard treatmentActive comparator 1 intervention
Group B: Fast-track treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Time from arrival at the emergency entrance to prosthesis reduction

Time frame
1 year

Secondary outcomes

1

Total hospitalization time from arrival to discharge

Time frame
1 year
2

Intra-operative complications (fracture, unsuccessful reduction, aspiration, need for mask ventilation and/or intubation, others)

Time frame
1 year
3

Post-operative complications (cardiac, pulmonal, thrombo-embolic events, nerve damage, re-dislocation, others) during hospitalization

Time frame
1 year
4

30 days re-admission

Time frame
30 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Southern Denmark

Lead sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: