Actively Recruiting

Phase Not Applicable
Age: 18Years - 67Years
All Genders
NCT05721378

Permissive Weight Bearing in Displaced Intra-articular Calcaneal Fractures

Led by Maastricht University Medical Center · Updated on 2024-10-17

115

Participants Needed

11

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of the proposed study is to define the optimal rehabilitation for trauma patients with Displaced Intra-articular Calcaneal Fractures, either Permissive Weight Bearing (PWB) or Restricted Weight Bearing (RWB) regarding functional outcomes, health related quality of life, radiographical differences, cost-effectiveness and complications.

CONDITIONS

Official Title

Permissive Weight Bearing in Displaced Intra-articular Calcaneal Fractures

Who Can Participate

Age: 18Years - 67Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Surgically treated trauma patients with isolated unilateral displaced intra-articular calcaneal fractures (DIACFs) less than 6 weeks after trauma, Sanders type II-IV
  • Age between 18 and 67 years old
  • Able to understand questionnaires and measurement instructions
  • Indicated for open or closed reduction and internal fixation surgery
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Acute or existing amputation of upper limb, lower limb, or feet
  • Open calcaneal fractures excluding medial wounds that do not affect surgical approach
  • Bilateral fractures of the lower extremities
  • Unable to follow the permissive weight bearing protocol due to pre-existing arm or leg conditions
  • Severe non-fracture related comorbidity of the lower extremity
  • Pre-existing immobility or loss of muscle function in one or both legs
  • Dependent in daily activities due to dementia, severe heart failure, or oxygen-dependent lung disease
  • Rheumatoid arthritis affecting lower extremities
  • Severe psychiatric conditions preventing protocol compliance
  • Pathologic fractures such as those caused by metastasis or secondary osteoporosis
  • Peripheral neuropathy or diabetes
  • Alcohol or drug abuse preventing adequate follow-up
  • Primary need for subtalar joint arthrodesis
  • Two or more fractures of upper and/or lower extremities

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 11 locations

1

Amsterdam University Medical Center

Amsterdam, Netherlands

Not Yet Recruiting

2

Rijnstate Hospital

Arnhem, Netherlands

Not Yet Recruiting

3

Amphia Hospital

Breda, Netherlands

Not Yet Recruiting

4

Catharina Hospital

Eindhoven, Netherlands

Not Yet Recruiting

5

Groene Hart Hospital

Gouda, Netherlands

Not Yet Recruiting

6

Maastricht University Medical Center +

Maastricht, Netherlands

Actively Recruiting

7

Radboud University Medical Center

Nijmegen, Netherlands

Actively Recruiting

8

Maasstad Hospital

Rotterdam, Netherlands

Not Yet Recruiting

9

Zuyderland Medical Center

Sittard, Netherlands

Not Yet Recruiting

10

Haaglanden Medical Center

The Hague, Netherlands

Not Yet Recruiting

11

Elisabeth-Twee Steden Hospital

Tilburg, Netherlands

Not Yet Recruiting

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Research Team

C

Coen Verstappen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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