Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
| Haukeland University Hospital | OTHER |
| Vestre Viken Hospital Trust | OTHER |
Not provided
Not provided
Not provided
Not provided
In this randomized controlled trial, the outcomes of two surgical techniques for intraarticular calcaneal fractures will be evaluated and compared.
Operative treatment of calcaneal features through an extensile lateral approach (ELA) has been the gold standard over many years despite high rates of infection and soft tissue complications.
Lately, there has been a trend towards less invasive fixation methods. Minimally invasive plate osteosynthesis using the sinus tarsi approach (STA) has gained popularity during the last decade.
Furthermore, percutaneous reduction and fixation techniques have been described and used for a few decades. In the early 2000s, Rammelt et al. were the first who introduced a percutaneous technique assisted by hindfoot arthroscopy. The percutaneous and arthroscopically assisted calcaneal osteosynthesis (PACO) is applicable in Sanders II and III fractures and has been shown to provide good clinical outcomes as well as a low rate of complications.
The study is designed as a superiority study. Our hypothesis is that the percutaneous and arthroscopically assisted technique provides superior outcomes compared to the sinus tarsi approach in Sanders II and III calcaneal fractures.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sinus tarsi approach (STA) | Active Comparator | Patients randomized to this arm are operated with plate osteosynthesis via the sinus tarsi approach |
|
| Percutaneous Arthroscopically Assisted Osteosynthesis (PACO) | Active Comparator | Patients randomized to this arm are operated with percutaneous reduction of the fracture and osteosynthesis with screws, assisted by subtalar arthroscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sinus tarsi approach (STA) | Procedure | Osteosynthesis |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Manchester-Oxford Foot Questionnaire (MOxFQ) | Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome) | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Calcaneus Fracture Scoring System (CFSS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Are Stødle, MD | Oslo University Hospital | Principal Investigator |
| Frede Frihagen, MD, PhD | Ostfold Hospital Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Bergen | Norway | ||||
| Vestre Viken Hospital Trust - Drammen hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Two-arm parallel assignment. Patients er randomized to operative treatment with either the sinus tarsi approach or percutaneous and arthroscopically assisted osteosynthesis.
Not provided
Not provided
The investigators that will conduct the follow-up examinations 2 and 5 years after surgery will be blinded for the operative treatment.
| Percutaneous Arthroscopically Assisted Osteosynthesis (PACO) |
| Procedure |
Osteosynthesis |
|
Calcaneal fracture specific scoring system (0-100 with 100 representing the best possible outcome)
| 5 years |
| Self-reported foot and ankle score (SEFAS) | Foot-Ankle specific PROM (0-48 with 48 representing the best possible outcome) | 5 years |
| Visual Analogue Scale (VAS) for pain | Scores pain at rest and on activity (0-10 with 0 representing no pain) | 5 years |
| Incidence of complications | Yes/no for deep or superficial infection, nerve or tendon injury, deep venous thrombosis, hardware complaints and secondary surgery | 5 years |
| Böhler angle | Böhler angle pre- and post surgery as well as at follow up | 5 years |
| 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 |
| 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 |
| Drammen |
| Norway |
| Oslo university hospial | Oslo | 0588 | Norway |
| Vestre Viken Hospital Trust - Bærum hospital | Sandvika | Norway |
| Østfold Hospital Trust | Sarpsborg | Østfold fylke | 1714 | Norway |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided