Surgery vs. Casting for Displaced Articular Radius Fractures in Elderly

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2022-11-01

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.

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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.

Conditions

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Radius Distal Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open reduction internal fixation

Surgical open reduction internal fixation (ORIF)

Group Type EXPERIMENTAL

Surgery (Open Reduction Internal Fixation)

Intervention Type PROCEDURE

Either volar of dorsal plating or both

Plaster immobilization

Standard local hospital protocol for cast treatment

Group Type ACTIVE_COMPARATOR

Cast treatment

Intervention Type PROCEDURE

Hospitals may use their preferred protocol

Interventions

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Surgery (Open Reduction Internal Fixation)

Either volar of dorsal plating or both

Intervention Type PROCEDURE

Cast treatment

Hospitals may use their preferred protocol

Intervention Type PROCEDURE

Other Intervention Names

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ORIF Open Reduction Internal Fixation Plaster

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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No