Weight-bearing of Surgically Treated Acetabular Fractures.

NCT04724811 | Not Yet Recruiting

• 1 other identifier: HUS/234/2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acetabular Fracture

Keywords

Acetabulum; Periarticular fracture; Weight-bearing

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• mHHS

  0 weeks, 6 weeks, 12 weeks, 6 months, 2 years, 5 years, 10 years

• NRS

  0 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years, 10 years

• WOMAC

  0 weeks, 1 year, 2 years, 5 years, 10 years

• RAND36

  0 weeks, 1 Year, 2 years, 5 years, 10 years

Other Outcomes (3)

• Complications

  At any point of time during treatment

• Total hip replacement

  During 10 years postoperatively

• Reduction of the articular surface after surgery

  Postoperatively

Study Arms (2)

Weight-bearing as tolerated

EXPERIMENTAL

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

Procedure: Open reduction and internal fixation (ORIF)

Touch-down weight-bearing

ACTIVE COMPARATOR

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

Procedure: Open reduction and internal fixation (ORIF)

Interventions

Open reduction and internal fixation (ORIF) PROCEDURE

Approaches used: * Intrapelvic approach +/- iliac window * Kocher-Langenbeck approach

Touch-down weight-bearing; Weight-bearing as tolerated

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital District of Helsinki and Uusimaa: lead

Study Sites (1)

Helsinki University Hospital

Helsinki, Uusimaa, 00029 HUS, Finland

Location

MeSH Terms

Interventions

Open Fracture Reduction; Fracture Fixation, Internal

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Jan Lindahl, MD, PhD

  Helsinki University Central Hospital

  STUDY CHAIR

• Kristian Seppänen, MD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristian Seppänen, MD

CONTACT

094711; kristian.seppanen@hus.fi

Jan Lindahl, MD, PhD

CONTACT

094711; jan.lindahl@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: The surgeon is masked The investigator is masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective randomised non-inferiority study

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: January 26, 2021
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)