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Weight-bearing of Surgically Treated Acetabular Fractures.

Primary Purpose

Acetabular Fracture

Status
Not yet recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Open reduction and internal fixation (ORIF)
Sponsored by
Hospital District of Helsinki and Uusimaa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acetabular Fracture focused on measuring Acetabulum, Periarticular fracture, Weight-bearing

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Helsinki University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Weight-bearing as tolerated

Touch-down weight-bearing

Arm Description

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

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

Outcomes

Primary Outcome Measures

mHHS
Modified Harris Hip Score
NRS
Pain during gate, Numerical Rating Scale

Secondary Outcome Measures

mHHS
Modified Harris Hip Score
NRS
Pain at rest and during gate, Numerical Rating Scale
WOMAC
Western Ontario and McMaster Universities Osteoarthritis Index
RAND36
Patient reported quality of life

Full Information

First Posted
January 22, 2021
Last Updated
January 22, 2021
Sponsor
Hospital District of Helsinki and Uusimaa
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1. Study Identification

Unique Protocol Identification Number
NCT04724811
Brief Title
Weight-bearing of Surgically Treated Acetabular Fractures.
Official Title
Weight-bearing of Surgically Treated Acetabular Fractures. A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2021 (Anticipated)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital District of Helsinki and Uusimaa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acetabular Fracture
Keywords
Acetabulum, Periarticular fracture, Weight-bearing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomised non-inferiority study
Masking
Care ProviderInvestigator
Masking Description
The surgeon is masked The investigator is masked
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Weight-bearing as tolerated
Arm Type
Experimental
Arm Description
Patients are instructed to mobilise the hip and weight-bear as tolerated
Arm Title
Touch-down weight-bearing
Arm Type
Active Comparator
Arm Description
Patients are instructed to mobilise the hip. Touch-down weight-bearing for 6-8 weeks
Intervention Type
Procedure
Intervention Name(s)
Open reduction and internal fixation (ORIF)
Intervention Description
Approaches used: Intrapelvic approach +/- iliac window Kocher-Langenbeck approach
Primary Outcome Measure Information:
Title
mHHS
Description
Modified Harris Hip Score
Time Frame
1 year
Title
NRS
Description
Pain during gate, Numerical Rating Scale
Time Frame
1 year
Secondary Outcome Measure Information:
Title
mHHS
Description
Modified Harris Hip Score
Time Frame
0 weeks, 6 weeks, 12 weeks, 6 months, 2 years, 5 years, 10 years
Title
NRS
Description
Pain at rest and during gate, Numerical Rating Scale
Time Frame
0 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years, 10 years
Title
WOMAC
Description
Western Ontario and McMaster Universities Osteoarthritis Index
Time Frame
0 weeks, 1 year, 2 years, 5 years, 10 years
Title
RAND36
Description
Patient reported quality of life
Time Frame
0 weeks, 1 Year, 2 years, 5 years, 10 years
Other Pre-specified Outcome Measures:
Title
Complications
Description
Intra-operative blood loss, nerve damage, loss of reduction, protrusion, re-operation, infection, VTE, AVN, heterotypic ossification, death
Time Frame
At any point of time during treatment
Title
Total hip replacement
Description
Conversion to total hip replacement
Time Frame
During 10 years postoperatively
Title
Reduction of the articular surface after surgery
Description
The reduction is assessed with a postoperative CT scan
Time Frame
Postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristian Seppänen, MD
Phone
094711
Email
kristian.seppanen@hus.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Lindahl, MD, PhD
Phone
094711
Email
jan.lindahl@hus.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Lindahl, MD, PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kristian Seppänen, MD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Hospital
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00029 HUS
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No

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Weight-bearing of Surgically Treated Acetabular Fractures.

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