Permissive Weight Bearing in Displaced Intra-articular Calcaneal Fractures

Last updated: October 15, 2024
Sponsor: Maastricht University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Permissive Weight Bearing group

Restricted Weight Bearing group

Clinical Study ID

NCT05721378
PIONEER
  • Ages 18-67
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Surgically treated trauma patients with isolated unilateral DIACFs, less than 6weeks after trauma, Sanders type II-IV (14)

  • Age between 18 and 67 years old (labor force)

  • Being able to understand the questionnaires and measurement instructions

  • Indication for open/closed reduction and internal fixation

  • Written Informed Consent

Exclusion

Exclusion Criteria:

  • Acute or existing amputation (upper limb, lower limb, feet)

  • Open calcaneal fractures (excluding medial wound without compromising surgicalapproach)

  • Bilateral fractures of the lower extremities

  • Unable to comply to the PWB protocol due to pre-existing conditions of the arms andlegs (e.g. unable to use crotches due to hemiparalysis)

  • Severe non-fracture related comorbidity of the lower extremity

  • Pre-existent immobility (loss of muscle function of one or both legs)

  • Dependent in activities of daily living (e.g. due to dementia, Alzheimer, New YorkHeart Association class IV angina, heart failure or oxygen-dependent chronicobstructive pulmonary disease)

  • Rheumatoid arthritis of the lower extremities

  • Severe psychiatric comorbidities that lead to inability to comply with the treatmentprotocol

  • Pathologic fractures (metastasis, secondary osteoporosis)

  • Peripheral neuropathy and/or diabetes

  • Alcohol- or drug abuse preventing adequate follow-up

  • Primary indication for arthrodesis subtalar joint

  • Two or more fractures of the upper and/or lower extremities

Study Design

Total Participants: 115
Treatment Group(s): 2
Primary Treatment: Permissive Weight Bearing group
Phase:
Study Start date:
July 01, 2024
Estimated Completion Date:
January 01, 2026

Study Description

Rationale: Of all fractures, 1-2% involve the calcaneus. Often surgical treatment is needed. Even after successful treatment it requires long rehabilitation with major impact on daily life and socio-economic aspects. Anatomic surgical restoration does not prevent gait disturbances or persistent foot pain. An adequate rehabilitation program is mandatory to maximize foot stability.

Objective: Evidence showing which rehabilitation protocol is best for both fracture healing and quality of life for patients with Displaced Intra-Articular Calcaneal Fractures (DIACFs) is mostly lacking. This study has the aim to answer the question whether surgically treated patients with DIACFs following the Permissive Weight Bearing protocol (PWB) have better functional outcomes compared to patients with Restricted Weight Bearing protocol after 12 weeks (RWB) measured with the American Orthopaedic Foot & Ankle Society (AOFAS) Score. The study hypothesizes that patients with DIACFs following the PWB protocol will have a better quality of life (HR-QOL) compared to patients who followed the RWB protocol.

The hypothesis is that there will be lower costs without any radiographic differences for surgically treated (irrespective of technique used) patients with DIACFs following a PWB protocol comparing to the current AO (Arbeitsgemeinschaft für Osteosynthesefragen) standard care: the RWB protocol.

Study design: Multi-center randomized controlled trial

Study population: Presence of surgically (extended lateral, sinus tarsi or percutaneous approach) fixed DIACFs classified as Sanders type II to IV, age 18-67 years (labor force). Patients must be able to understand and follow weight bearing instructions. Patients will only be included after written informed consent is obtained.

Groups (intervention and control): Patients with DIACFs will be randomly allocated to one of the rehabilitation protocols, either PWB or RWB.

Main study parameters/endpoints: Primary objective: functional outcome. Secondary outcomes: quality of life, differences in radiographic parameters, complications, cost effectiveness and differences in surgical techniques.

Nature and extent of the burden: The PWB protocol aims to restore weight bearing faster than RWB protocol in DIACFs. Early postoperative weight bearing poses the risk of increased complications, such as secondary displacement of the fracture or failure of fracture fixation. Previous analysis of this protocol in other lower extremity fractures has shown a safe complication rate, although data from prospective randomized trials in calcaneus fractures are lacking. Follow-up is standardized according to current trauma guidelines, namely at time points 2, 6, 12 weeks and 6 months. The radiation exposure will not be different from standard of care. Therefore, the burden for participants is considered minimal, with no significant health risks.

Connect with a study center

  • Amsterdam University Medical Center

    Amsterdam,
    Netherlands

    Site Not Available

  • Rijnstate Hospital

    Arnhem,
    Netherlands

    Site Not Available

  • Amphia Hospital

    Breda,
    Netherlands

    Site Not Available

  • Haaglanden Medical Center

    Den Haag,
    Netherlands

    Site Not Available

  • Catharina Hospital

    Eindhoven,
    Netherlands

    Site Not Available

  • Groene Hart Hospital

    Gouda,
    Netherlands

    Site Not Available

  • Maastricht University Medical Center +

    Maastricht,
    Netherlands

    Active - Recruiting

  • Radboud University Medical Center

    Nijmegen,
    Netherlands

    Active - Recruiting

  • Maasstad Hospital

    Rotterdam,
    Netherlands

    Site Not Available

  • Zuyderland Medical Center

    Sittard,
    Netherlands

    Site Not Available

  • Elisabeth-Twee Steden Hospital

    Tilburg,
    Netherlands

    Site Not Available

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