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NCT Number: NCT04724811

Weight-bearing of Surgically Treated Acetabular Fractures.

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.

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Key information

Conditions

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital

Helsinki, Uusimaa, 00029 HUS, Finland

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Open reduction and internal fixation (ORIF)

Procedure

Approaches used:

  • Intrapelvic approach +/- iliac window
  • Kocher-Langenbeck approach

Primary outcomes

  1. mHHS

    Time frame: 1 year

    Modified Harris Hip Score, Scale 0-100, higher scores mean better outcome

  2. NRS

    Time frame: 1 year

    Pain during gate, Numerical Rating Scale, Scale 0-10 0=no pain, 10=worst pain

Secondary outcomes

  1. mHHS

    Time frame: 0 weeks, 6 weeks, 12 weeks, 6 months, 2 years, 5 years, 10 years

    Modified Harris Hip Score, Scale 0-100, higher scores mean better outcome

  2. NRS

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

    Pain at rest and during gate (2 scores), Numerical Rating Scale, Scale 0-10 0=no pain, 10=worst pain

  3. WOMAC

    Time frame: 0 weeks, 1 year, 2 years, 5 years, 10 years

    Western Ontario and McMaster Universities Osteoarthritis Index, Scale 0-96, higher scores mean better outcome

  4. RAND36

    Time frame: 0 weeks, 1 Year, 2 years, 5 years, 10 years

    Patient reported quality of life, Scale 0-100, higher scores mean better outcome

Other outcomes

  1. Complications

    Time frame: At any point of time during treatment

    Any complications during treatment are documented

  2. Total hip replacement

    Time frame: During 10 years postoperatively

    Conversion to total hip replacement

  3. Reduction of the articular surface after surgery

    Time frame: Postoperatively

    The reduction is assessed with a postoperative CT scan

Study contacts

Contact information is provided by the study sponsor or research team.

Jan Lindahl, MD, PhD

CONTACT

[email protected]

094711

Kristian Seppänen, MD

CONTACT

[email protected]

094711

Sponsors and collaborators

Lead sponsor

Hospital District of Helsinki and Uusimaa

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 26, 2021
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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