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OpenTrials
Completed

NCT Number: NCT03009890

Surgery vs. Casting for Displaced Articular Radius Fractures in Elderly

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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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, 1090 HM, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgery (Open Reduction Internal Fixation)

Procedure

Either volar of dorsal plating or both

Other names: ORIF Open Reduction Internal Fixation

Cast treatment

Procedure

Hospitals may use their preferred protocol

Other names: Plaster

Primary outcomes

  1. PRWE

    Time frame: 12 months

    Patient-Rated Wrist Evaluation score

Secondary outcomes

  1. DASH

    Time frame: 12 months

    Disability of the Arm, Shoulder and Hand

  2. EQ/5D

    Time frame: 12 months

    Quality of life

  3. PCS

    Time frame: 12 months

    Pain Catastrophizing Scale

Other outcomes

  1. ROM

    Time frame: 12 months

    range of motion

  2. grip strength

    Time frame: 12 months

    grip strength of both wrists

  3. Radiographic parameters

    Time frame: 6 months

    Radial inclination, volar/dorsal tilt, ulnar variance, gap, step off and radial length

  4. Complications

    Time frame: 12 months

    Complications of either treatment arm

Sponsors and collaborators

Lead sponsor

JointResearch

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Deventer Ziekenhuis
  • Maasstad Hospital

Registry information

Official study title

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

Acronym: DART

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jan 4, 2017
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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