Helsinki University Hospital
Helsinki, Uusimaa, 00029 HUS, Finland
NCT Number: NCT04724811
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
* Type of fracture (anterior approach vs anterior + additional posterior approach) * Dislocated dome vs non-dislocated/ non existing separate dome fragment
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.
Trial opening soon.
Get Notified60 year and older
All sexes
Interventional
Not applicable
Helsinki, Uusimaa, 00029 HUS, Finland
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Approaches used:
Time frame: 1 year
Modified Harris Hip Score, Scale 0-100, higher scores mean better outcome
Time frame: 1 year
Pain during gate, Numerical Rating Scale, Scale 0-10 0=no pain, 10=worst pain
Time frame: 0 weeks, 6 weeks, 12 weeks, 6 months, 2 years, 5 years, 10 years
Modified Harris Hip Score, Scale 0-100, higher scores mean better outcome
Time frame: 0 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years, 10 years
Pain at rest and during gate (2 scores), Numerical Rating Scale, Scale 0-10 0=no pain, 10=worst pain
Time frame: 0 weeks, 1 year, 2 years, 5 years, 10 years
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
Patient reported quality of life, Scale 0-100, higher scores mean better outcome
Time frame: At any point of time during treatment
Any complications during treatment are documented
Time frame: During 10 years postoperatively
Conversion to total hip replacement
Time frame: Postoperatively
The reduction is assessed with a postoperative CT scan
Contact information is provided by the study sponsor or research team.
Jan Lindahl, MD, PhD
CONTACT
Kristian Seppänen, MD
CONTACT
Hospital District of Helsinki and Uusimaa
Other
Weight-bearing of Surgically Treated Acetabular Fractures. A Randomised Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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.
Published trials that share one or more normalized conditions with this study.
NCT03713853
Acetabular Fracture
Toronto, Ontario, Canada
View Trial DetailsNCT07609758
Acetabular Fracture
Salt Lake City, Utah, United States
View Trial DetailsNCT06409559
Acetabular Fracture
Cincinnati, Ohio, United States
View Trial DetailsNCT04615104
Acetabular Fracture, Femoral Fractures
Charlotte, North Carolina, United States
View Trial Details