Surgery vs. Casting for Displaced Articular Radius Fractures in Elderly (DART)

JointResearch

Status: Completed

Conditions: Radius Distal Fracture

Treatments: Procedure: Surgery (Open Reduction Internal Fixation); Procedure: Cast treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03009890

NL56858.100.16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

138 participants in 2 patient groups

Open reduction internal fixation

Experimental group

Description:

Surgical open reduction internal fixation (ORIF)

Treatment:

Procedure: Surgery (Open Reduction Internal Fixation)

Plaster immobilization

Active Comparator group

Description:

Standard local hospital protocol for cast treatment

Treatment:

Procedure: Cast treatment