Clinical trial NCT05721378: Permissive Weight Bearing in Displaced Intra-articular Calcaneal Fractures
Official title: (Cost-)effectiveness of Permissive Weight Bearing in Surgically Treated Trauma Patients with Displaced Intra-Articular Calcaneal Fractures: a Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Calcaneus Fracture
Displaced Intra-Articular Fracture of Calcaneus (Diagnosis)
Trauma Injury
Keywords: Permissive Weight Bearing
Rehabilitation
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
measure: Change in functional outcome as defined by the AOFAS questionnaire
timeFrame: 0, 2, 6, 12 weeks and 6 months post-surgery.
Secondary outcomes:
measure: Self-reported function with the Maryland Foot Score
timeFrame: 0, 2, 6, 12 weeks and 6 months post-surgery
measure: Activities of Daily Living (ADL) with LEFS
timeFrame: 0, 2, 6, 12 weeks and 6 months post-surgery
measure: Health Related Quality of Life with EQ-5D-5L
timeFrame: 0, 2, 6, 12 weeks and 6 months post-surgery
measure: Böhlers angle and posterior facet joint
timeFrame: Early postoperative (before first mobilization) and 6 months post-surgery
measure: Medical consumption with iMCQ
timeFrame: 0 weeks and 6 months post-surgery
measure: Society costs with iPCQ
timeFrame: 0 weeks and 6 months post-surgery
measure: Occurrence of complications
timeFrame: 6 and 12 weeks and 6 months post-surgery
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Breda
country: Netherlands
facility: Amphia Hospital
city: Den Haag
country: Netherlands
facility: Haaglanden Medical Center
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Gouda
country: Netherlands
facility: Groene Hart Hospital
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center +
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital
city: Sittard
country: Netherlands
facility: Zuyderland Medical Center
city: Tilburg
country: Netherlands
facility: Elisabeth-Twee Steden Hospital
Study officials:
References: