Surgery vs. Casting for Displaced Articular Radius Fractures in Elderly

Study Overview
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Brief Summary
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Objective: to compare the functional outcome after open reduction and internal fixation with non-operative cast treatment for elderly patients with displaced intra-articular distal radius fractures.

Detailed Description
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Rationale: there is no consensus about the optimal treatment of displaced intra-articular distal radius fractures in elderly patients. To ensure optimal functional outcome there is a tendency to operate. However, there is no evidence that supports the surgical treatment of patients aged 65 years or older and in the absence of clinical trials it stays unclear how elderly patients with intra-articular fractures should be treated. Study design: multi-center randomized controlled trial with a non-inferiority design. Economic evaluation alongside a randomized controlled multi-center trial. Study population: all consecutive patients aged between 65 years and older with displaced intra-articular (AO Type C) distal radius fractures, with a not acceptable reduction within 3 weeks following trauma. Intervention: patients will be randomized between open reduction and internal fixation (intervention group) and plaster immobilization (control group). Main study parameters: the primary outcome will be evaluated after 1 year with the Patient-Rated Wrist Evaluation score (PRWE). Secondary outcomes comprise other patient reported outcome measures (PROM) including the Disability of the Arm, Shoulder and Hand (DASH), Quality of life (EQ-5D) and Pain Catastrophizing Scale (PCS). Further outcome measurements comprise a costs evaluation questionnaire, range of motion (ROM), grip strength, radiographic parameters and Complications.

Official Title
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The Effectiveness of Surgery Versus Casting for Elderly Patients With Displaced Distal Intra-Articular Radius Fractures: A Randomized Controlled Trial

Conditions
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Radius Distal Fracture

Intervention / Treatment
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* Procedure: Surgery (Open Reduction Internal Fixation)
* Procedure: Cast treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 65 years at time of trauma Intra-articular distal radius fracture (AO type C*) One or more of the following fracture characteristics within 3 weeks post-trauma (including secondary dislocation): ≤15° inclination <5 mm radial length >15° dorsal tilt >20° volar tilt intra-articular gap or step-off >2 mm < 3 weeks post trauma Living independent Fit for surgery Mentally competent Dutch fluency and literacy Informed consent Exclusion Criteria: Open fractures Neurovascular damage Multiple-trauma patients (ISS >16) Other fractures in the injured extremity other than ulnar styloid process fractures

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open reduction internal fixation<br>Surgical open reduction internal fixation (ORIF) | Procedure: Surgery (Open Reduction Internal Fixation)<br>* Either volar of dorsal plating or both<br>* Other names: ORIF Open Reduction Internal Fixation;|
| Active Comparator: Plaster immobilization<br>Standard local hospital protocol for cast treatment | Procedure: Cast treatment<br>* Hospitals may use their preferred protocol<br>* Other names: Plaster;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PRWE | Patient-Rated Wrist Evaluation score | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DASH | Disability of the Arm, Shoulder and Hand | 12 months | 
| EQ/5D | Quality of life | 12 months | 
| PCS | Pain Catastrophizing Scale | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elderly, intra articular, RCT