THANCT06639334
The Q-REDUCE Study
A study testing Fasttrack pathway for THA/HE prosthesis reduction and Standard pathway for THA/HE prosthesis reduction in people with THA and Dislocation, Hip, run by University of Southern Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- THA, Dislocation, Hip, PROM
- What is being tested?
- Fasttrack pathway for THA/HE prosthesis reduction and Standard pathway for THA/HE prosthesis reduction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: 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
- Conditions
- THA, Dislocation, Hip, PROM
- Being tested
- Fasttrack pathway for THA/HE prosthesis reduction, Standard pathway for THA/HE prosthesis reduction
- Medical subject headings
- Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasttrack pathway for THA/HE prosthesis reductionOther
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 reductionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | Active comparator | Standard pathway for THA/HE reduction Receives: Other: Standard pathway for THA/HE prosthesis reduction |
| Fast-track treatment | Experimental | Fasttrack pathway for THA/HE reduction Receives: Other: Fasttrack pathway for THA/HE prosthesis reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from arrival at the emergency entrance to prosthesis reduction
Measured: 1 year
Secondary outcomes (11)
Total hospitalization time from arrival to discharge
Measured: 1 year
Intra-operative complications (fracture, unsuccessful reduction, aspiration, need for mask ventilation and/or intubation, others)
Measured: 1 year
Post-operative complications (cardiac, pulmonal, thrombo-embolic events, nerve damage, re-dislocation, others) during hospitalization
Measured: 1 year
30 days re-admission
Measured: 30 days
30- and 90-days mortality
Measured: 30 and 90 days
Hip-related pain measured by a 10-digit numeric rating scale (NRS)
Evaluated from 1 (best) to 10 (worst).
Measured: 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).
Measured: Day 0, 14, 90, 180 and 365
Health-related quality of life using the EQ-5D questionnaire
Measured: Day 0, 14, 90, 180 and 365
Patient satisfaction
Consists of four self-developed questions.
Measured: During hospital admission, day 1.
Time consumption by the involved staff (orthopedic, anesthetic, radiology staff etc.)
Measured: 1 year
Total hospital costs during admission
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for THAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Esbjerg Hospital - University Hospital of Southern Denmark
- Responsible party
- Principal investigator, Lars Lykke Hermansen, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639334
- Sponsor's protocol ID
- 24/34681
- Status last verified
- Oct 2024
- First submitted
- 29 Jul 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40623887
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06639334
- Acronym / sponsor ID
- 24/34681
- Conditions
- THA, Dislocation, Hip, PROM
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Esbjerg Hospital - University Hospital of Southern Denmark
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | Active comparator | Other: Standard pathway for THA/HE prosthesis reductionStandard pathway for THA/HE reduction |
| Fast-track treatment | Experimental | Other: Fasttrack pathway for THA/HE prosthesis reductionFasttrack pathway for THA/HE reduction |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasttrack pathway for THA/HE prosthesis reductionThe 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. | Other | Fast-track treatment |
| Standard pathway for THA/HE prosthesis reductionStandard 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. | Other | Standard treatment |
Primary outcome
Time from arrival at the emergency entrance to prosthesis reduction
Time frame: 1 year
11 secondary outcomes
Total hospitalization time from arrival to discharge
Time frame: 1 year
Intra-operative complications (fracture, unsuccessful reduction, aspiration, need for mask ventilation and/or intubation, others)
Time frame: 1 year
Post-operative complications (cardiac, pulmonal, thrombo-embolic events, nerve damage, re-dislocation, others) during hospitalization
Time frame: 1 year
30 days re-admission
Time frame: 30 days
30- and 90-days mortality
Time frame: 30 and 90 days
Hip-related pain measured by a 10-digit numeric rating scale (NRS)
Time frame: Day 0, 1, 3, 7, 14 and 30
Patient-reported outcome (PRO) using the Hip disability and Osteoarthritis Outcome Score (HOOS),
Time frame: Day 0, 14, 90, 180 and 365
Health-related quality of life using the EQ-5D questionnaire
Time frame: Day 0, 14, 90, 180 and 365
Patient satisfaction
Time frame: During hospital admission, day 1.
Time consumption by the involved staff (orthopedic, anesthetic, radiology staff etc.)
Time frame: 1 year
Total hospital costs during admission
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 40623887Eggers 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fasttrack pathway for THA/HE prosthesis reduction and Standard pathway for THA/HE prosthesis reduction in people with THA and Dislocation, Hip, run by University of Southern Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from arrival at the emergency entrance to prosthesis reduction (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06639334, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.