Calcaneus Fracture Clinical Trial
Official title:
Osteosynthesis of Intraarticular Calcaneal Fractures: Arthroscopically Assisted Percutaneous Technique Versus Sinus Tarsi Approach - A Randomized Controlled Multicenter Trial
NCT number | NCT04372251 |
Other study ID # | 20/00912 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 5, 2020 |
Est. completion date | December 2031 |
In this randomized controlled trial, the outcomes of two surgical techniques for intraarticular calcaneal fractures will be evaluated and compared.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | December 2031 |
Est. primary completion date | December 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Dislocated intraarticular calcaneal fracture, type Sanders II or Sanders III with an intraarticular step > 2mm - Patients between 18 and 70 years of age - Acute presentation at one of our departments, enabling surgery within 10 days after injury Exclusion Criteria: - Intraarticular step of < 2mm - Sanders IV fractures - Open fractures - Bilateral injuries - Concomitant major injuries of the foot, ankle or leg that affect the rehabilitation process - Multitraumized patients - Previous injury or surgery of the hindfoot - Charcot foot - Serious medical condition that contradicts surgery - Noncompliant patients - Insufficient Norwegian or English language skills - Patients not available for follow-up - Inability to conduct the rehabilitation protocol |
Country | Name | City | State |
---|---|---|---|
Norway | Haukeland University Hospital | Bergen | |
Norway | Vestre Viken Hospital Trust - Drammen hospital | Drammen | |
Norway | Oslo university hospial | Oslo | |
Norway | Vestre Viken Hospital Trust - Bærum hospital | Sandvika | |
Norway | Østfold Hospital Trust | Sarpsborg | Østfold |
Lead Sponsor | Collaborator |
---|---|
Ostfold Hospital Trust | Haukeland University Hospital, Oslo University Hospital, Vestre Viken Hospital Trust |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Manchester-Oxford Foot Questionnaire (MOxFQ) | Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome) | 5 years | |
Secondary | American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score | Widely used foot/ankle score (0-100 with 100 representing the best possible outcome) | 5 years | |
Secondary | Calcaneus Fracture Scoring System (CFSS) | Calcaneal fracture specific scoring system (0-100 with 100 representing the best possible outcome) | 5 years | |
Secondary | Self-reported foot and ankle score (SEFAS) | Foot-Ankle specific PROM (0-48 with 48 representing the best possible outcome) | 5 years | |
Secondary | Visual Analogue Scale (VAS) for pain | Scores pain at rest and on activity (0-10 with 0 representing no pain) | 5 years | |
Secondary | Incidence of complications | Yes/no for deep or superficial infection, nerve or tendon injury, deep venous thrombosis, hardware complaints and secondary surgery | 5 years | |
Secondary | Böhler angle | Böhler angle pre- and post surgery as well as at follow up | 5 years | |
Secondary | Subtalar osteoarthritis | The presence of subtalar osteoarthritis is graded based CT scans taken at the 2 year and 5 year follow-up using the Kellgren & Lawrence classification system. | 5 years | |
Secondary | EQ-5D-5L | Measure of health-related quality of life. This will be evaluated at the 2-year and 5 -year follow-up. | 5 years |
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