An interventional study of Compression screws and neutralization plate and Acumed Fibular Rod System in Ankle Fractures, sponsored by Oslo University Hospital. Active, not recruiting at 1 site in Norway. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2023-07-13.
Sponsored by Oslo University Hospital · Not applicable, Interventional, and Treatment
Among 12 studies in Ankle Fractures with a site in Norway — 2 open to participants now, 6 under way, none of them phase 3. Ankle Fractures · Norway.
Among the 12 studies in Ankle Fractures with a site in Norway, this one is the 3rd largest by enrollment of the 11 interventional ones that give a count, is one of 2 that started in 2016, is one of 10 with no phase, and was the 4th registered.
202 studies on the registry are indexed under Ankle Fractures; 44 are open to participants now.
Browse Ankle Fractures studies →2 of the 12 studies in Ankle Fractures with a site in Norway are open now. Recruiting first, the newest first:
Ostfold Hospital Trust · Sites in Norway
Ages 18–65
Haukeland University Hospital · Sites in Norway
Ages 18–65
A study can be open while its sites in Norway have not opened yet or have stopped. Only those recruiting at a site in Norway →
Of the 31 Ankle Fractures studies recruiting now, 14 (45%) set no upper age limit and 12 (39%) stop at 75 or younger; 4 take children under 18; 3 take healthy volunteers.
This study: 60 Years and older · all sexes · no healthy volunteers.
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12 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 2 started in 2016.
This study's enrollment of 120 is above the median of 90 across 150 interventional studies indexed under Ankle Fractures.
Median enrollment 120 across the 11 interventional studies, 840 across the 1 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.
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None of the 12 has an industry lead sponsor. The 5 most frequent:
Oslo University Hospital is the lead sponsor of 834 studies on the registry; 149 are open to participants now.
Oslo University Hospital has 5 studies filed under Ankle Fractures — fewer than ten, so there is no comparison to draw.
1 of the studies in Ankle Fractures with a site in Norway that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06568276Ostfold Hospital TrustThe Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures | 2026-12-31 |
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Among the 12 studies in Ankle Fractures with a site in Norway, from their registry updates:
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The purpose of this study is to make a survey of functional outcome, radiological outcome and complication rate after intramedullary nailing (IMN) and plate fixation of Weber B ankle fractures in elderly patients, and contribute in choosing the best surgical method for these ankle fractures.
Open reduction and internal fixation (ORIF) is the gold standard treatment for unstable Weber B fractures, using compression screws and a neutralization plate. In the elderly, pre-existing co-morbidities, osteoporosis and poor skin conditions may give a high complication rate, including wound complications, symptomatic hardware and hardware failure. Due to concerns with complications related to ORIF, the technique with intramedullary fixation has been introduced. This method may simplify the management when poor skin conditions and osteoporotic bone, and has the potential to reduce the risk of soft tissue and hardware complications. Previous studies have showed that intramedullary fixation is probably the best choice for treating unstable ankle fractures in elderly patients, but more studies are needed to conclude the superiority to standard plate fixation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Compression screws and neutralization plate.
Device: Compression screws and neutralization plate
Acumed Fibular Rod System
Device: Acumed Fibular Rod System
Open reduction and internal fixation with screws and plate
intramedullary nailing of fibula
American Orthopaedic Foot and Ankle Society (AOFAS) score
Functional outcome as assessed by AOFAS score (0-100)
Time frame: 5 years
Manchester-Oxford Foot questionnaire (MOxFQ)
Patient reported outcome as assessed by MOxFQ (0-100)
Time frame: 5 years
Olerud and Molander Score (OMS)
Patient reported outcome as assessed by OMS (0-100)
Time frame: 5 years
EuroQol-5d (Eq-5d)
Patient reported quality of life as assessed by Eq-5d index score
Time frame: 5 years
Visual analogue scale (VAS)
VAS scores for pain during rest (0-10), during walking (0-10), at night (0-10), and during daily activities (0-10), where 10 is best
Time frame: 5 years
Fracture reduction as assessed by CT scans
Number of patients with good, fair or poor fracture reduction
Time frame: 3 months
Malunion as assessed by CT scans
Number of patients with malunion
Time frame: 5 years
Nonunion as assessed by CT scans
Number of patients with nonunion
Time frame: 5 years
Osteoarthritis as assessed by CT scans
Number of patients with osteoarthritis assessed according to the criteria by McLennan et al
Time frame: 5 years
Infection
Number of patients with wound infection or deep infection
Time frame: 3 months
Delayed wound healing
Number of patients with delayed wound healing
Time frame: 3 months
Other complications
Number of patients with other complications (e.g. hardware complications, tromboemolism, neurologic complications, peroneus tendon irritation)
Time frame: 5 years
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2016 to primary completion in Jun 2021, 60 months.
Of 69 non-industry interventional studies with no phase under Ankle Fractures, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 61. This study's 60 months is above that.
Counting every sponsor, half of 72 studies reached it within 45 months; a quarter within 23 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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