ClinicalTrials.gg
Not yet recruitingNCT06639334Updated Oct 15, 2024

The Q-REDUCE Study

An interventional study of Fasttrack pathway for THA/HE prosthesis reduction and Standard pathway for THA/HE prosthesis reduction in THA, Dislocation, Hip and PROM, sponsored by University of Southern Denmark. Not yet recruiting. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by University of Southern Denmark · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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

02

Conditions studied

  • THA
  • Dislocation, Hip
  • PROM

Browse trials for

03

In context

Hip Dislocation

107 studies on the registry are indexed under Hip Dislocation; 36 are open to participants now.

This study's planned enrollment of 120 is above the median of 86 across 64 interventional studies indexed under Hip Dislocation.

Browse Hip Dislocation studies →

Lead sponsor

University of Southern Denmark is the lead sponsor of 336 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
  • (ASA) score > 3
  • (BMI) > 40
  • active drug abuse
  • for Propofol or Esketamine
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    Standard treatment

    Standard pathway for THA/HE reduction

    Other: Standard pathway for THA/HE prosthesis reduction

  • Experimental
    Fast-track treatment

    Fasttrack pathway for THA/HE reduction

    Other: Fasttrack pathway for THA/HE prosthesis reduction

Interventions

  • OtherFasttrack 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.

  • OtherStandard 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.

06

What researchers measure

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

  5. 30- and 90-days mortality

    Time frame: 30 and 90 days

  6. 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

  7. 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

  8. Health-related quality of life using the EQ-5D questionnaire

    Time frame: Day 0, 14, 90, 180 and 365

  9. Patient satisfaction

    Consists of four self-developed questions.

    Time frame: During hospital admission, day 1.

  10. Time consumption by the involved staff (orthopedic, anesthetic, radiology staff etc.)

    Time frame: 1 year

  11. Total hospital costs during admission

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2024; primary completion for Aug 2026, 21 months later.

Of 32 interventional studies with no phase under Hip Dislocation, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 18. This study's planned 21 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2024
First posted
Oct 15, 2024
StartEst.
Nov 1, 2024
Primary completionEst.
Aug 31, 2026
CompletionEst.
Aug 31, 2027
Last update
Oct 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06639334
Collaborators
University Hospital of Southern Denmark
Responsible party
Lars Lykke Hermansen (MD, PhD, University of Southern Denmark) — Principal investigator
First posted
Oct 15, 2024
Start date
Nov 1, 2024 (estimated)
Primary completion
Aug 31, 2026 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Oct 15, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion