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Calcaneus FracturePIONEERNCT05721378

Permissive Weight Bearing in Displaced Intra-articular Calcaneal Fractures

A study testing Permissive Weight Bearing group and Restricted Weight Bearing group in people with Calcaneus Fracture and Displaced Intra-Articular Fracture of Calcaneus (Diagnosis), run by Maastricht University Medical Center at 11 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 67 years
What is being tested?
Permissive Weight Bearing group and Restricted Weight Bearing group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
11 sitesNetherlands
Study dates
1 Jul 2024to 1 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 67 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Surgically treated trauma patients with isolated unilateral DIACFs, less than 6 weeks 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

Who cannot join

  • Acute or existing amputation (upper limb, lower limb, feet)
  • Open calcaneal fractures (excluding medial wound without compromising surgical approach)
  • Bilateral fractures of the lower extremities
  • Unable to comply to the PWB protocol due to pre-existing conditions of the arms and legs (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)
Show all 14Show fewer
  • Dependent in activities of daily living (e.g. due to dementia, Alzheimer, New York Heart Association class IV angina, heart failure or oxygen-dependent chronic obstructive pulmonary disease)
  • Rheumatoid arthritis of the lower extremities
  • Severe psychiatric comorbidities that lead to inability to comply with the treatment protocol
  • 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

Trial locations and contacts

11 sites in 1 country.

Coen Verstappen, MD contact

+31(0)43-3877489

coen.verstappen@mumc.nl

11 sites in 1 country

Netherlands11 sites, 11 recruiting
  • Amsterdam University Medical Center

    Amsterdam

    Tim Schepers, MD

    Not yet recruiting
  • Rijnstate Hospital

    Arnhem

    Albert Pull ter Gunne, MD

    Not yet recruiting
  • Amphia Hospital

    Breda

    Niels Berende, MD

    Not yet recruiting
  • Catharina Hospital

    Eindhoven

    Alexander van der Veen, MD

    Not yet recruiting
  • Groene Hart Hospital

    Gouda

    Jan Siert Reinders, MD

    Not yet recruiting
  • Maastricht University Medical Center +

    Maastricht

    Martijn Poeze, Prof.

    Recruiting
  • Radboud University Medical Center

    Nijmegen

    Erik Hermans, MD

    Recruiting
  • Maasstad Hospital

    Rotterdam

    Kees van der Vlies, MD

    Not yet recruiting
  • Zuyderland Medical Center

    Sittard

    Raoul van Vugt, MD

    Not yet recruiting
  • Haaglanden Medical Center

    The Hague

    Jochem Hoogendoorn, MD

    Not yet recruiting
  • Elisabeth-Twee Steden Hospital

    Tilburg

    Hilco Theeuwes, MD

    Not yet recruiting

Other trials in Netherlands

About this study

Official title: (Cost-)effectiveness of Permissive Weight Bearing in Surgically Treated Trauma Patients with Displaced Intra-Articular Calcaneal Fractures: a Multicenter, Randomized Controlled Trial

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.

Read the detailed 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.

Being tested
Permissive Weight Bearing group, Restricted Weight Bearing group
Keywords
Permissive Weight Bearing, Rehabilitation
Medical subject headings
Disease, Accidental Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Permissive Weight Bearing groupProcedure or surgery

    Also called Early Weight Bearing

    The Permissive Weight Bearing (PWB) protocol allows earlier post-operative permissive weight bearing, where progression of weight bearing is guided by the subjective experience (for example: pain, weight bearing tolerance) of the patient and the clinical expertise of the treating physician and therapist. Patients allocated to the PWB protocol start weight bearing after wound healing is achieved (approximately two weeks after the operation). Consequently, patients are stimulated to bear as much weight as tolerated by pain and comfort. Treatment will take place according to the PROMETHEUS protocol (treatment- and evaluation protocol). The protocol contains a number of weight bearing milestones (e.g. walking with two crutches, walking with two canes, walking with one cane and walking without any walking aids). The treating physiotherapist or physician records the dates that these milestones are reached in the study database.

  • Restricted Weight Bearing groupProcedure or surgery

    Also called Non Weight Bearing

    The Restrictive Weight Bearing (RWB) protocol consists of 8 to 12 weeks of postoperative restricted weight (0-10%) bearing, following the current AO Guidelines (7). After 8 weeks of restricted weight bearing, the weight bearing will be increased with 25% per week for 4 weeks. Every time the patient and the treating physical therapist or physician have contact, the weight bearing advice given to the patient at that point in time is recorded (unloaded; partial weight bearing + clarification; full weight bearing). Also, any additional advice given to the patient is recorded.

Study groups in NCT05721378
Study groupRoleWhat they receive
Permissive Weight Bearing groupExperimentalRehabilitation following the Permissive Weight Bearing (PWB) protocol
Receives: Procedure: Permissive Weight Bearing group
Restrictive Weight Bearing groupActive comparatorRehabilitation following the Restrictive Weight Bearing (RWB) protocol
Receives: Procedure: Restricted Weight Bearing group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in functional outcome as defined by the AOFAS questionnaire

    The American Orthopaedic Foot \& Ankle Society (AOFAS) score is a clinician-based score. It incorporates both subjective and objective information. Patients report their pain, and physicians assess alignment. It is designed for physicians to help standardize the assessment of patients and makes the results of this study comparable with previous data. Scores range from 0 to 100, with healthy foot and ankles receiving 100 points.

    Measured: 0, 2, 6, 12 weeks and 6 months post-surgery.

Secondary outcomes (7)
  1. Self-reported function with the Maryland Foot Score

    The MFS is an assessment for foot disorders, mainly consisting of the following items: pain, gait, functional activities, and cosmesis. The scale scores have a minimum of 0 points and a maximum of 100 points. A total score of <50 is considered as poor, 50-74 as fair, 75-89 as good, and 90-100 as excellent.

    Measured: 0, 2, 6, 12 weeks and 6 months post-surgery

  2. Activities of Daily Living (ADL) with LEFS

    The lower extremity functional scale (LEFS) is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The LEFS can be used by clinicians as a measure of patients' initial function, ongoing progress, and outcome, as well as to set functional goals. The LEFS can be used to evaluate the functional impairment of a patient with a disorder of one or both lower extremities. It can be used to monitor the patient over time and to evaluate the effectiveness of an intervention. The questionnaire consists of 80 points. The lower the score the greater the disability.

    Measured: 0, 2, 6, 12 weeks and 6 months post-surgery

  3. Health Related Quality of Life with EQ-5D-5L

    The EuroQol 5-Dimension, 5-Level Health Scale (EQ-5D-5L) is a self-administered questionnaire, which will be completed at baseline together with the cost questionnaire at the same moments (0, 2, 6, 12 weeks and 6 months). Both generic quality of life, as well as utilities, will be derived by means of the EQ-5D-5L, which will be administered both by the patients. The Dutch version of the EQ-5D-5L is chosen because it is a widely used quality of life instrument (nationally and internationally) and it is recommended by the Dutch guidelines.The EQ-5D-5L contains 5 dimensions of health-related quality of life, namely mobility, self-care, daily activities, pain/discomfort and depression/anxiety. Each dimension can be rated at five levels: no problems to major problems. The 5 dimensions can be summed into a health state.

    Measured: 0, 2, 6, 12 weeks and 6 months post-surgery

  4. Böhlers angle and posterior facet joint

    Radiographic evaluation by a radiologist blinded for treatment allocation will be done at the same time intervals as the scheduled visits to the physician.

    To see if there is a difference in the alignment of Böhlers angle and posterior facet joint alignment (radiographically measured), a CT-scan will be performed early post-operatively (before first weight bearing) and after 6 months. Differences in the Böhlers angle and posterior joint alignment (Δ = CT6months - CTpost-op.) will be calculated. The normal degree for the Böhler angle varieties between 25° and 40°. An intra-articular step off or gap from less than 2mm of the posterior facet was considered as well-reduced.

    Measured: Early postoperative (before first mobilization) and 6 months post-surgery

  5. Medical consumption with iMCQ

    The iMTA Medical Consumption Questionnaire (iMCQ) measures health care utilization and is based on 29 questions. It is an instrument for measuring medical consumption and is related to frequently occurring contacts with health care providers. The iMCQ is a generic questionnaire. It is therefore not disease specific. The questions ask about health care related appointments patients had in the past period. In case the respondent had no appointments, the score '0' is noted.

    Measured: 0 weeks and 6 months post-surgery

  6. Society costs with iPCQ

    The iMTA Productivity Cost Questionnaire (iPCQ) measures productivity losses. The questionnaire is based on 12 questions. Questions 1 to 3 give information about the amount of paid work (in hours) and the number of days per week on which the respondent works. The latter provides insight into the average number of hours of work per working day of the respondent. This information is needed to calculate productivity loss costs.

    The questions about productivity losses form the following modules:

    • Absenteeism: absenteeism from paid work (questions 4 to 6)
    • Presenteeism: productivity losses during days worked (questions 7 to 9)
    • Productivity loss from unpaid work (questions 10 to 12). After completing the questionnaire the total amount of absenteeism can be calculated by multiplying the number of days absent and the number of hours per working day of the respondent.

    To calculate the costs of productivity losses, volumes are multiplied by unit cost prices.

    Measured: 0 weeks and 6 months post-surgery

  7. Occurrence of complications

    Most important complications, such as: wound infection, dislocation, non-union, - failure of osteosynthesis, postoperative arthritis

    Measured: 6 and 12 weeks and 6 months post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2023
  2. Study start1 Jul 2024
  3. Primary completion1 Jul 2025 (estimated)
  4. Study completion1 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
115 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05721378
Sponsor's protocol ID
PIONEER
Acronym
PIONEER
Status last verified
Oct 2024
First submitted
13 Jan 2023
Last updated
17 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Verstappen C, Driessen MLS, Kalmet PHS, Brandts L, Kimman M, Edwards M, Hermans E, Poeze M. Permissive weight bearing versus restrictive weight bearing in surgically treated trauma patients with displaced intra-articular calcaneal fractures (the PIONEER study): study protocol for a multicenter randomized controlled trial. Trials. 2024 Nov 18;25(1):778. doi: 10.1186/s13063-024-08617-5.

    PubMed 39558368

Questions about this trial

What is this clinical trial studying?

A study testing Permissive Weight Bearing group and Restricted Weight Bearing group in people with Calcaneus Fracture and Displaced Intra-Articular Fracture of Calcaneus (Diagnosis), run by Maastricht University Medical Center at 11 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Coen Verstappen, MD (+31(0)43-3877489, coen.verstappen@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in functional outcome as defined by the AOFAS questionnaire (time frame: 0, 2, 6, 12 weeks and 6 months post-surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05721378, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.

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