Onze Lieve Vrouwe Gasthuis
Amsterdam, North Holland, 1090 HM, Netherlands
NCT Number: NCT03009890
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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Notify Me65 year and older
All sexes
Interventional
Not applicable
Amsterdam, North Holland, 1090 HM, Netherlands
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
≤15° inclination <5 mm radial length >15° dorsal tilt >20° volar tilt intra-articular gap or step-off >2 mm
Exclusion criteria
Either volar of dorsal plating or both
Other names: ORIF Open Reduction Internal Fixation
Hospitals may use their preferred protocol
Other names: Plaster
Time frame: 12 months
Patient-Rated Wrist Evaluation score
Time frame: 12 months
Disability of the Arm, Shoulder and Hand
Time frame: 12 months
Quality of life
Time frame: 12 months
Pain Catastrophizing Scale
Time frame: 12 months
range of motion
Time frame: 12 months
grip strength of both wrists
Time frame: 6 months
Radial inclination, volar/dorsal tilt, ulnar variance, gap, step off and radial length
Time frame: 12 months
Complications of either treatment arm
JointResearch
Other
The Effectiveness of Surgery Versus Casting for Elderly Patients With Displaced Distal Intra-Articular Radius Fractures: A Randomized Controlled Trial
Acronym: DART
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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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