Surgery vs. Casting for Displaced Articular Radius Fractures in Elderly

Not Applicable

Completed

• Conditions: Radius Distal Fracture
• Interventions: Procedure: Cast treatment; Procedure: Surgery (Open Reduction Internal Fixation)

• Registration Number: NCT03009890
• Lead Sponsor: JointResearch

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-12-22
• Study First Submitted QC: 2017-01-02
• Study First Posted: 2017-01-04
• Study Start: 2017-02-01
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plaster immobilization	Cast treatment	Standard local hospital protocol for cast treatment
Open reduction internal fixation	Surgery (Open Reduction Internal Fixation)	Surgical open reduction internal fixation (ORIF)

Primary Outcome Measures

Name	Time	Method
PRWE	12 months	Patient-Rated Wrist Evaluation score

Secondary Outcome Measures

Name	Time	Method
DASH	12 months	Disability of the Arm, Shoulder and Hand
EQ/5D	12 months	Quality of life
PCS	12 months	Pain Catastrophizing Scale

Trial Locations

Locations (1)

Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Noord Holland, Netherlands