Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05721378
Status:
RECRUITING
Last Update Posted:
2023-10-19
First Post:
2023-01-13
Brief Title:
Permissive Weight Bearing in Displaced Intra-articular Calcaneal Fractures
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
Cost-effectiveness of Permissive Weight Bearing in Surgically Treated Trauma Patients with Displaced Intra-Articular Calcaneal Fractures a Multicenter Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIONEER
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 parametersendpoints 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
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 parametersendpoints 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None