An interventional study of Surgery (Open Reduction Internal Fixation) and Cast treatment in Radius Distal Fracture, sponsored by JointResearch. Completed at 1 site in Netherlands. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-01-18.
Sponsored by JointResearch · Not applicable, Interventional, and Treatment
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Among 13 studies in Wrist Fractures with a site in Netherlands — 2 open to participants now, 3 under way, none of them phase 3. Wrist Fractures · Netherlands.
Among the 13 studies in Wrist Fractures with a site in Netherlands, this one is the 2nd largest by enrollment of the 11 interventional ones that give a count, is one of 2 that started in 2017, is one of 10 with no phase, and was the 6th registered.
330 studies on the registry are indexed under Wrist Fractures; 72 are open to participants now.
Browse Wrist Fractures studies →2 of the 13 studies in Wrist Fractures with a site in Netherlands are open now. Recruiting first, the newest first:
Medical Centre Leeuwarden · Sites in Netherlands
Ages 16+
Spaarne Gasthuis · Sites in Netherlands
Ages 18–50
A study can be open while its sites in Netherlands have not opened yet or have stopped. Only those recruiting at a site in Netherlands →
Of the 43 Wrist Fractures studies recruiting now, 20 (47%) set no upper age limit and 15 (35%) stop at 75 or younger; 7 take children under 18; 6 take healthy volunteers.
This study: 65 Years and older · all sexes · no healthy volunteers.
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13 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 2 started in 2017.
This study's enrollment of 138 is above the median of 63 across 265 interventional studies indexed under Wrist Fractures.
Median enrollment 86 across the 11 interventional studies, 850 across the 2 observational. Of the 10 that completed or were terminated, 1 (10%) have results posted.
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1 of 13 have an industry lead sponsor. The 10 most frequent:
JointResearch is the lead sponsor of 14 studies on the registry; 7 are open to participants now.
JointResearch has 2 studies filed under Wrist Fractures — fewer than ten, so there is no comparison to draw.
1 of the studies in Wrist Fractures with a site in Netherlands that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04113044AO Innovation Translation CenterGo Fit Fast, Recovery Trajectory Using PROMIS®, Linking PROMIS® | 2026-12-31 |
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Among the 13 studies in Wrist Fractures with a site in Netherlands, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
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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
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Surgical open reduction internal fixation (ORIF)
Procedure: Surgery (Open Reduction Internal Fixation)
Standard local hospital protocol for cast treatment
Procedure: Cast treatment
Either volar of dorsal plating or both
Also known as: ORIF Open Reduction Internal Fixation
Hospitals may use their preferred protocol
Also known as: Plaster
PRWE
Patient-Rated Wrist Evaluation score
Time frame: 12 months
DASH
Disability of the Arm, Shoulder and Hand
Time frame: 12 months
EQ/5D
Quality of life
Time frame: 12 months
PCS
Pain Catastrophizing Scale
Time frame: 12 months
ROM
range of motion
Time frame: 12 months
grip strength
grip strength of both wrists
Time frame: 12 months
Radiographic parameters
Radial inclination, volar/dorsal tilt, ulnar variance, gap, step off and radial length
Time frame: 6 months
Complications
Complications of either treatment arm
Time frame: 12 months
Plan to share: Yes
Ran from Feb 2017 to primary completion in Nov 2022, 69 months.
Of 126 non-industry interventional studies with no phase under Wrist Fractures, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's 69 months is above that.
Counting every sponsor, half of 127 studies reached it within 25 months; a quarter within 16 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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JointResearch