An interventional study of Open reduction and internal fixation (ORIF) in Acetabular Fracture, sponsored by Hospital District of Helsinki and Uusimaa. Not yet recruiting at 1 site in Finland. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by Hospital District of Helsinki and Uusimaa · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether patients with operatively treated acetabular fractures benefit from early weight-bearing as tolerated. The study compares two groups ( n = 25 each), which are randomised into either weight-bearing as tolerated or touch-down weight-bearing for 6-8 weeks postoperatively.
Both study groups are stratified according to
Patients, who are eligible to participate in the trial but choose not to participate in randomisation are asked to enrol in a prospective cohort follow-up cohort. This is to examine a potential participation bias in the RCT groups. These patients will not be counted into the target amount of 50 RCT patients.
For the past 20 years, the established treatment of dislocated acetabular fractures has been surgical reduction and stable osteosynthesis. Good long-term results have been reported in these patients. At present, the mobilisation of these patients after surgery is generally restricted for several weeks ranging from 6-12 weeks touch-down- or non-weight-bearing with no uniform protocol. However there is no scientific evidence for limiting post operative weight-bearing. Accordingly the need of studies on weight-bearing surrounding periarticular fractures has been advocated.
Acetabular fractures in the elderly population are becoming more common and pose significant challenges for treatment including postoperative rehabilitation. Our aim is to investigate if patients benefit of a more liberal weight-bearing regime postoperatively. The primary outcome is measured at 1 year, secondary outcomes are followed up to 10 years postoperatively
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's planned enrollment of 50 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Hospital District of Helsinki and Uusimaa is the lead sponsor of 14 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients are instructed to mobilise the hip and weight-bear as tolerated
Procedure: Open reduction and internal fixation (ORIF)
Patients are instructed to mobilise the hip. Touch-down weight-bearing for 6-8 weeks
Procedure: Open reduction and internal fixation (ORIF)
Approaches used: * Intrapelvic approach +/- iliac window * Kocher-Langenbeck approach
mHHS
Modified Harris Hip Score, Scale 0-100, higher scores mean better outcome
Time frame: 1 year
NRS
Pain during gate, Numerical Rating Scale, Scale 0-10 0=no pain, 10=worst pain
Time frame: 1 year
mHHS
Modified Harris Hip Score, Scale 0-100, higher scores mean better outcome
Time frame: 0 weeks, 6 weeks, 12 weeks, 6 months, 2 years, 5 years, 10 years
NRS
Pain at rest and during gate (2 scores), Numerical Rating Scale, Scale 0-10 0=no pain, 10=worst pain
Time frame: 0 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years, 10 years
WOMAC
Western Ontario and McMaster Universities Osteoarthritis Index, Scale 0-96, higher scores mean better outcome
Time frame: 0 weeks, 1 year, 2 years, 5 years, 10 years
RAND36
Patient reported quality of life, Scale 0-100, higher scores mean better outcome
Time frame: 0 weeks, 1 Year, 2 years, 5 years, 10 years
Complications
Any complications during treatment are documented
Time frame: At any point of time during treatment
Total hip replacement
Conversion to total hip replacement
Time frame: During 10 years postoperatively
Reduction of the articular surface after surgery
The reduction is assessed with a postoperative CT scan
Time frame: Postoperatively
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Hospital District of Helsinki and Uusimaa