Weight-bearing of Surgically Treated Acetabular Fractures.

NCT ID: NCT04724811

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2027-12-31

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

Conditions

Acetabular Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Weight-bearing as tolerated

Patients are instructed to mobilise the hip and weight-bear as tolerated

Group Type: EXPERIMENTAL

Open reduction and internal fixation (ORIF)

Intervention Type: PROCEDURE

Approaches used:

• Intrapelvic approach +/- iliac window
• Kocher-Langenbeck approach

Touch-down weight-bearing

Patients are instructed to mobilise the hip. Touch-down weight-bearing for 6-8 weeks

Group Type: ACTIVE_COMPARATOR

Open reduction and internal fixation (ORIF)

Intervention Type: PROCEDURE

Approaches used:

• Intrapelvic approach +/- iliac window
• Kocher-Langenbeck approach

Interventions

Open reduction and internal fixation (ORIF)

Approaches used:

• Intrapelvic approach +/- iliac window
• Kocher-Langenbeck approach

Intervention Type: PROCEDURE

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
• 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital District of Helsinki and Uusimaa

OTHER

Sponsor Role: lead

Responsible Party

Kristian Seppänen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan Lindahl, MD, PhD

Role: STUDY_CHAIR

Helsinki University Central Hospital

Kristian Seppänen, MD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

Helsinki University Hospital

Helsinki, Uusimaa, Finland

Countries

Finland

Central Contacts

Kristian Seppänen, MD

Role: CONTACT

kristian.seppanen@hus.fi

094711

Jan Lindahl, MD, PhD

Role: CONTACT

jan.lindahl@hus.fi

094711

Other Identifiers

HUS/234/2020

Identifier Type: -

Identifier Source: org_study_id