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Weight-bearing of Surgically Treated Acetabular Fractures.

NCT04724811 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-03-06

No results posted yet for this study

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

Interventions

PROCEDURE

Open reduction and internal fixation (ORIF)

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

Sponsors & Collaborators

  • Hospital District of Helsinki and Uusimaa

    lead OTHER

Principal Investigators

  • Jan Lindahl, MD, PhD · Helsinki University Central Hospital

  • Kristian Seppänen, MD · Helsinki University Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04724811 on ClinicalTrials.gov