Weight-bearing of Surgically Treated Acetabular Fractures.

Weight-bearing of Surgically Treated Acetabular Fractures. A Randomised Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acetabular Fracture
• Intervention / Treatment: Procedure: Open reduction and internal fixation (ORIF)

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

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristian Seppänen, MD; Phone Number: 094711; Email: kristian.seppanen@hus.fi
• Study Contact Backup: Name: Jan Lindahl, MD, PhD; Phone Number: 094711; Email: jan.lindahl@hus.fi

Study Locations

• Finland
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00029 HUS
      • Helsinki University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Weight-bearing as tolerated; Patients are instructed to mobilise the hip and weight-bear as tolerated	Procedure: Open reduction and internal fixation (ORIF); Approaches used: Intrapelvic approach +/- iliac window; Kocher-Langenbeck approach
Active Comparator: Touch-down weight-bearing; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mHHS	Modified Harris Hip Score, Scale 0-100, higher scores mean better outcome	1 year
NRS	Pain during gate, Numerical Rating Scale, Scale 0-10 0=no pain, 10=worst pain	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mHHS	Modified Harris Hip Score, Scale 0-100, higher scores mean better outcome	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	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	0 weeks, 1 year, 2 years, 5 years, 10 years
RAND36	Patient reported quality of life, Scale 0-100, higher scores mean better outcome	0 weeks, 1 Year, 2 years, 5 years, 10 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total hip replacement	Conversion to total hip replacement	During 10 years postoperatively
Reduction of the articular surface after surgery	The reduction is assessed with a postoperative CT scan	Postoperatively
Complications	Any complications during treatment are documented	At any point of time during treatment

Collaborators and Investigators

• Sponsor: Hospital District of Helsinki and Uusimaa
• Investigators: Study Chair: Jan Lindahl, MD, PhD, Helsinki University Central Hospital; Principal Investigator: Kristian Seppänen, MD, Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 22, 2021
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Acetabulum; Weight-bearing; Periarticular fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: HUS/234/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No