Sponsor study identifier
interventional
115
1 country
11
Study Start
July 1, 2024
Actual (reported)Primary Completion
July 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 13, 2023
Actual (reported)February 10, 2023
Actual (reported)July 1, 2024
Actual (reported)July 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
0, 2, 6, 12 weeks and 6 months post-surgery.
Self-reported function with the Maryland Foot Score
0, 2, 6, 12 weeks and 6 months post-surgery
Activities of Daily Living (ADL) with LEFS
0, 2, 6, 12 weeks and 6 months post-surgery
Health Related Quality of Life with EQ-5D-5L
0, 2, 6, 12 weeks and 6 months post-surgery
Böhlers angle and posterior facet joint
Early postoperative (before first mobilization) and 6 months post-surgery
Medical consumption with iMCQ
0 weeks and 6 months post-surgery
Rehabilitation following the Permissive Weight Bearing (PWB) protocol
Rehabilitation following the Restrictive Weight Bearing (RWB) protocol
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.
Amsterdam University Medical Center
Amsterdam, Netherlands
Rijnstate Hospital
Arnhem, Netherlands
Amphia Hospital
Breda, Netherlands
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.
First Submitted
January 13, 2023
First Posted
February 10, 2023
Study Start
July 1, 2024
Actual (reported)Primary Completion
July 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Osteosynthesis of Intraarticular Calcaneal Fractures: Arthroscopically Assisted Percutaneous Technique Versus Sinus Tarsi Approach
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.
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Catharina Hospital
Eindhoven, Netherlands
Groene Hart Hospital
Gouda, Netherlands
Maastricht University Medical Center +
Maastricht, Netherlands
Radboud University Medical Center
Nijmegen, Netherlands
Maasstad Hospital
Rotterdam, Netherlands
Zuyderland Medical Center
Sittard, Netherlands
Haaglanden Medical Center
The Hague, Netherlands
Elisabeth-Twee Steden Hospital
Tilburg, Netherlands
Study Completion
January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 17, 2024
Record last verified: 2024-10
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Source: ClinicalTrials.gov.
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