Radius FracturesHE-VOCALNCT06067074
Cost-effectiveness, Volar Locking Plate or Non-operative Treatment Distal Radius Fracture
A study testing Volar Locking Plate and Plaster Cast in people with Radius Fractures and Aged, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
A cost-utility analysis based on an earlier published RCT comparing surgery with volar locking plate to non-operative treatment for the elderly with a displaced distal radius fracture. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Radius Fractures, Aged, Cost-Benefit Analysis
- What is being tested?
- Volar Locking Plate and Plaster Cast
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSweden
- Study dates
- 8 Feb 2022to 4 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patient >70 years
- wrist radiograph >20° dorsal tilt and/or +/-4 mm axial shortening
Who cannot join
- Former disability of either wrist
- Intra-articular fractures with a step-off of >1 mm or a gap of > 1 mm (at Sodersjukhuset Hospital)
- High-energy trauma (Sodersjukhuset Hospital)
- Associated ulnar fracture
- Injury to ipsilateral upper extremity
- Rheumatoid arthritis or other severe joint disorders
Show all 12Show fewer
- Dementia or Pfeiffer score of <5 at Sodersjukhuset Hospital and <8 at Danderyd Hospital
- Drug or alcohol abuse or psychiatric disorder
- Dependency in activities of daily living
- Patient not a resident within the catchment area of the 2 centers
- Fracture diagnosed >3 days from injury at Sodersjukhuset Hospital and >6 days at Danderyd Hospital
- Patient not fit for surgery or American Society of Anesthesiologists class 4
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Division ot Ortopeadics
Stockholm
About this study
Official title: Is it Cost-effective With Volar Plating Surgery Compared to Non-operative Treatment for Distal Radius Fracture in the Elderly?
A cost-utility analysis based on an earlier published RCT comparing surgery with volar locking plate to non-operative treatment for the elderly with a displaced distal radius fracture.
Read the detailed description
Study design: A cost-utility analysis of a patient population included in a previous published randomized controlled trial.
Patient population:140 patients 70 years of age or older with a displaced distal radius fracture that met the inclusion and no exclusion criteria at Danderyd Hospital or Södersjukhuset Hospital were randomized to volar locking plate or non-operative treatment with a cast.
Primary outcome: Incremental cost-effectiveness ratio (ICER) at 1 and 3 years.
Data collection: Prospectively collected clinical data is available for 4, 12, weeks, 1 and 3 years. Costs will be analysed regarding surgical equipment, inpatient stay, surgical time. Prescriptions of analgesics and antibiotics as well as inpatient and outpatient consumption over a three years period after the injury will be retrieved from the Swedish National Board of Health and Welfare.The life expectancy adjusted life years (QALYs) is calculated from prospectively collected results from EQ-5D.
- Conditions
- Radius Fractures, Aged, Cost-Benefit Analysis, Wrist Fracture, Quality of Life, Wrist Injuries
- Being tested
- Volar Locking Plate, Plaster Cast
- Medical subject headings
- Radius Fractures, Wrist Fractures, Wrist Injuries, Postoperative Complications, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volar Locking PlateProcedure or surgery
Surgery
Plaster CastProcedure or surgery
Non-operative treatment with a plaster cast
| Study group | Role | What they receive |
|---|---|---|
| Volar Locking Plate | Experimental | Surgery with a Volar Locking Plate due to displaced distal radius fracture Receives: Procedure: Volar Locking Plate |
| Non-operative treatment group | Experimental | Patients allocated to non-operative treatment received a plaster cast for 4-5 weeks. Receives: Procedure: Plaster Cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Cost-Effectiveness Ratio (ICER) at 1 year.
difference in cost divided by difference in quality of life
Measured: 1 year
Secondary outcomes (2)
Absolute cost difference
difference in cost between treatments
Measured: 1 and 3 years
ICER at 3 years
difference in cost divided by difference in quality of life
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start8 Feb 2022
- Primary completion4 Nov 2024 (estimated)
- Study completion4 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radius FracturesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallell study arms with the intervention volar locking plate and control treatment forearm cast. We investigate the difference in health cost between the two groups.
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecilia Mellstrand Navarro, Karolinska Institutet
- Investigators
- Olof Sköldenberg, professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067074
- Sponsor's protocol ID
- study2
- Acronym
- HE-VOCAL
- Status last verified
- Oct 2023
- First submitted
- 12 May 2022
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is it Cost-effective With Volar Plating Surgery Compared to Non-operative Treatment for Distal Radius Fracture in the Elderly?
- ClinicalTrials.gov ID
- NCT06067074
- Acronym / sponsor ID
- HE-VOCAL / study2
- Conditions
- Radius Fractures, Aged, Cost-Benefit Analysis, Wrist Fracture, Quality of Life, Wrist Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 4 Nov 2024 (estimated)
- Study completion
- 4 Nov 2024 (estimated)
- First posted
- 4 Oct 2023 (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.
A cost-utility analysis based on an earlier published RCT comparing surgery with volar locking plate to non-operative treatment for the elderly with a displaced distal radius fracture.
Detailed description
Study design: A cost-utility analysis of a patient population included in a previous published randomized controlled trial.
Patient population:140 patients 70 years of age or older with a displaced distal radius fracture that met the inclusion and no exclusion criteria at Danderyd Hospital or Södersjukhuset Hospital were randomized to volar locking plate or non-operative treatment with a cast.
Primary outcome: Incremental cost-effectiveness ratio (ICER) at 1 and 3 years.
Data collection: Prospectively collected clinical data is available for 4, 12, weeks, 1 and 3 years. Costs will be analysed regarding surgical equipment, inpatient stay, surgical time. Prescriptions of analgesics and antibiotics as well as inpatient and outpatient consumption over a three years period after the injury will be retrieved from the Swedish National Board of Health and Welfare.The life expectancy adjusted life years (QALYs) is calculated from prospectively collected results from EQ-5D.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallell study arms with the intervention volar locking plate and control treatment forearm cast. We investigate the difference in health cost between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Volar Locking Plate | Experimental | Procedure: Volar Locking PlateSurgery with a Volar Locking Plate due to displaced distal radius fracture |
| Non-operative treatment group | Experimental | Procedure: Plaster CastPatients allocated to non-operative treatment received a plaster cast for 4-5 weeks. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- patient >70 years
- wrist radiograph >20° dorsal tilt and/or +/-4 mm axial shortening
Key exclusion criteria (12 listed)
- Former disability of either wrist
- Intra-articular fractures with a step-off of >1 mm or a gap of > 1 mm (at Sodersjukhuset Hospital)
- High-energy trauma (Sodersjukhuset Hospital)
- Associated ulnar fracture
- Injury to ipsilateral upper extremity
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 |
|---|---|---|
| Volar Locking PlateSurgery | Procedure or surgery | Volar Locking Plate |
| Plaster CastNon-operative treatment with a plaster cast | Procedure or surgery | Non-operative treatment group |
Primary outcome
Incremental Cost-Effectiveness Ratio (ICER) at 1 year.
Time frame: 1 year
difference in cost divided by difference in quality of life
2 secondary outcomes
Absolute cost difference
Time frame: 1 and 3 years
ICER at 3 years
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Radius Fractures
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
Active, not recruiting
Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate
Distal Radius Fracture
Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Not yet recruiting
One Inch Punch High Impact Training Randomized Control Trial (1'' Punch HIT RCT)
Distal Radius Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
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. This study is not recruiting at the moment.
Olof Sköldenberg, professor principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volar Locking Plate and Plaster Cast in people with Radius Fractures and Aged, run by Karolinska Institutet at 1 site in Sweden.
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 2 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Incremental Cost-Effectiveness Ratio (ICER) at 1 year. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2023.