Cost-effectiveness, Volar Locking Plate or Non-operative Treatment Distal Radius Fracture
NCT ID: NCT06067074
Last Updated: 2023-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
140 participants
INTERVENTIONAL
2022-02-08
2024-11-04
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Volar Locking Plate
Surgery with a Volar Locking Plate due to displaced distal radius fracture
Volar Locking Plate
Surgery
Non-operative treatment group
Patients allocated to non-operative treatment received a plaster cast for 4-5 weeks.
Plaster Cast
Non-operative treatment with a plaster cast
Interventions
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Volar Locking Plate
Surgery
Plaster Cast
Non-operative treatment with a plaster cast
Eligibility Criteria
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Inclusion Criteria
* wrist radiograph \>20° dorsal tilt and/or +/-4 mm axial shortening
Exclusion Criteria
* 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
* 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
70 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Cecilia Mellstrand Navarro
associate professor
Principal Investigators
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Olof Sköldenberg, professor
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Division ot Ortopeadics
Stockholm, , Sweden
Countries
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Other Identifiers
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study2
Identifier Type: -
Identifier Source: org_study_id
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