Weight-bearing of Surgically Treated Acetabular Fractures.

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Acetabular Fracture

Intervention / Treatment
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* Procedure: Open reduction and internal fixation (ORIF)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomised non-inferiority study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight-bearing as tolerated<br>Patients are instructed to mobilise the hip and weight-bear as tolerated | Procedure: Open reduction and internal fixation (ORIF)<br>* Approaches used: Intrapelvic approach +/- iliac window Kocher-Langenbeck approach<br>|
| Active Comparator: Touch-down weight-bearing<br>Patients are instructed to mobilise the hip. Touch-down weight-bearing for 6-8 weeks | Procedure: Open reduction and internal fixation (ORIF)<br>* Approaches used: Intrapelvic approach +/- iliac window Kocher-Langenbeck approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mHHS | Modified Harris Hip Score | 1 year | 
| NRS | Pain during gate, Numerical Rating Scale | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mHHS | Modified Harris Hip Score | 0 weeks, 6 weeks, 12 weeks, 6 months, 2 years, 5 years, 10 years | 
| NRS | Pain at rest and during gate, Numerical Rating Scale | 0 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years, 10 years | 
| WOMAC | Western Ontario and McMaster Universities Osteoarthritis Index | 0 weeks, 1 year, 2 years, 5 years, 10 years | 
| RAND36 | Patient reported quality of life | 0 weeks, 1 Year, 2 years, 5 years, 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acetabulum, Periarticular fracture, Weight-bearing