Clinical trial NCT04724811: Weight-bearing of Surgically Treated Acetabular Fractures.
Official title: Weight-bearing of Surgically Treated Acetabular Fractures. A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acetabular Fracture
Keywords: Acetabulum
Periarticular fracture
Weight-bearing
Lead sponsor: Hospital District of Helsinki and Uusimaa
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomised non-inferiority study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Unilateral dislocated acetabulum fracture (displacement of over 2mm in preoperative CT scan)
* The osteosynthesis is performed during 21 days after initial trauma
* The patient is willing to participate in the follow-up

Exclusion Criteria:

* Unwillingness to participate in randomisation
* Bilateral fracture
* Letournel \& Judet type Both column or Posterior column and wall fractures
* Any other injury that prevents the patient from partial weight bearing
* Open fracture of the acetabulum
* Pathologic fracture (fragility fractures are not an exclusion criteria)
* Prior functional disability in the pelvis or lower extremity
* Non-Compliance due to dementia or other mental disability
* Prior daily pain medication due to hip-pain
* Unwillingness to accept one of the two mobilisation protocols
* Prior hip replacement on injured side
* BMI \> 40

Primary outcomes:
measure: mHHS
timeFrame: 1 year
measure: NRS
timeFrame: 1 year
Secondary outcomes:
measure: mHHS
timeFrame: 0 weeks, 6 weeks, 12 weeks, 6 months, 2 years, 5 years, 10 years
measure: NRS
timeFrame: 0 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years, 10 years
measure: WOMAC
timeFrame: 0 weeks, 1 year, 2 years, 5 years, 10 years
measure: RAND36
timeFrame: 0 weeks, 1 Year, 2 years, 5 years, 10 years
Other outcomes:
measure: Complications
timeFrame: At any point of time during treatment
measure: Total hip replacement
timeFrame: During 10 years postoperatively
measure: Reduction of the articular surface after surgery
timeFrame: Postoperatively
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
state: Uusimaa
Study officials:
affiliation: Helsinki University Central Hospital
name: Jan Lindahl, MD, PhD
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Kristian Seppänen, MD
role: PRINCIPAL_INVESTIGATOR
References: