Clinical trial NCT03009890: Surgery vs. Casting for Displaced Articular Radius Fractures in Elderly
Official title: The Effectiveness of Surgery Versus Casting for Elderly Patients With Displaced Distal Intra-Articular Radius Fractures: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radius Distal Fracture
Keywords: elderly
intra articular
RCT
Lead sponsor: JointResearch
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Maasstad Hospital
name: Deventer Ziekenhuis
First posted: 2017-01-04
Enrollment: 138
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: PRWE
timeFrame: 12 months
Secondary outcomes:
measure: DASH
timeFrame: 12 months
measure: EQ/5D
timeFrame: 12 months
measure: PCS
timeFrame: 12 months
Other outcomes:
measure: ROM
timeFrame: 12 months
measure: grip strength
timeFrame: 12 months
measure: Radiographic parameters
timeFrame: 6 months
measure: Complications
timeFrame: 12 months
Locations:
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
state: Noord Holland
Study officials:
affiliation: OLVG, Amsterdam, the Netherlands
name: Rudolf W Poolman, Prof. MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ter Meulen DP, Mulders MAM, Kruiswijk AA, Kret EJ, Slichter ME, van Dongen JM, Kerkhoffs GMMJ, Goslings JC, Kleinlugtenbelt YV, Willigenburg NW, Schep NWL, Poolman RW; DART Study Group. Effectiveness and cost-effectiveness of surgery versus casting for elderly patients with Displaced intra-Articular type C distal Radius fractures: protocol of a randomised controlled Trial with economic evaluation (the DART study). BMJ Open. 2022 Apr 1;12(4):e051658. doi: 10.1136/bmjopen-2021-051658.