Calcaneus FractureNCT04372251
Osteosynthesis of Intraarticular Calcaneal Fractures: Arthroscopically Assisted Percutaneous Technique Versus Sinus Tarsi Approach
A study testing Sinus tarsi approach (STA) and Percutaneous Arthroscopically Assisted Osteosynthesis (PACO) in people with Calcaneus Fracture, run by Ostfold Hospital Trust at 5 sites in Norway.
Trial summary
In this randomized controlled trial, the outcomes of two surgical techniques for intraarticular calcaneal fractures will be evaluated and compared. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Calcaneus Fracture
- What is being tested?
- Sinus tarsi approach (STA) and Percutaneous Arthroscopically Assisted Osteosynthesis (PACO)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 5 sitesNorway
- Study dates
- 5 May 2020to Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Norway5 sites
Haukeland University Hospital
Bergen
Vestre Viken Hospital Trust - Drammen hospital
Drammen
Oslo university hospial
Oslo, 0588
Vestre Viken Hospital Trust - Bærum hospital
Sandvika
Østfold Hospital Trust
Sarpsborg, Østfold fylke, 1714
About this study
Official title: Osteosynthesis of Intraarticular Calcaneal Fractures: Arthroscopically Assisted Percutaneous Technique Versus Sinus Tarsi Approach - A Randomized Controlled Multicenter Trial
In this randomized controlled trial, the outcomes of two surgical techniques for intraarticular calcaneal fractures will be evaluated and compared.
Read the detailed description
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.
- Conditions
- Calcaneus Fracture
- Being tested
- Sinus tarsi approach (STA), Percutaneous Arthroscopically Assisted Osteosynthesis (PACO)
- Keywords
- Calcaneal fracture, Subtalar arthroscopy, Trauma, Calcaneus
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinus tarsi approach (STA)Procedure or surgery
Osteosynthesis
Percutaneous Arthroscopically Assisted Osteosynthesis (PACO)Procedure or surgery
Osteosynthesis
| Study group | Role | What they receive |
|---|---|---|
| Sinus tarsi approach (STA) | Active comparator | Patients randomized to this arm are operated with plate osteosynthesis via the sinus tarsi approach Receives: Procedure: Sinus tarsi approach (STA) |
| 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 Receives: Procedure: Percutaneous Arthroscopically Assisted Osteosynthesis (PACO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manchester-Oxford Foot Questionnaire (MOxFQ)
Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome)
Measured: 5 years
Secondary outcomes (8)
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score
Widely used foot/ankle score (0-100 with 100 representing the best possible outcome)
Measured: 5 years
Calcaneus Fracture Scoring System (CFSS)
Calcaneal fracture specific scoring system (0-100 with 100 representing the best possible outcome)
Measured: 5 years
Self-reported foot and ankle score (SEFAS)
Foot-Ankle specific PROM (0-48 with 48 representing the best possible outcome)
Measured: 5 years
Visual Analogue Scale (VAS) for pain
Scores pain at rest and on activity (0-10 with 0 representing no pain)
Measured: 5 years
Incidence of complications
Yes/no for deep or superficial infection, nerve or tendon injury, deep venous thrombosis, hardware complaints and secondary surgery
Measured: 5 years
Böhler angle
Böhler angle pre- and post surgery as well as at follow up
Measured: 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.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start5 May 2020
- Primary completionDec 2030 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcaneus FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel assignment. Patients er randomized to operative treatment with either the sinus tarsi approach or percutaneous and arthroscopically assisted osteosynthesis.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, Haukeland University Hospital, Vestre Viken Hospital Trust
- Responsible party
- Sponsor
- Investigators
- Are Stødle, MD, Principal investigator, Oslo University HospitalFrede Frihagen, MD, PhD, Principal investigator, Ostfold Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372251
- Sponsor's protocol ID
- 20/00912
- Status last verified
- Dec 2024
- First submitted
- 29 Apr 2020
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteosynthesis of Intraarticular Calcaneal Fractures: Arthroscopically Assisted Percutaneous Technique Versus Sinus Tarsi Approach - A Randomized Controlled Multicenter Trial
- ClinicalTrials.gov ID
- NCT04372251
- Acronym / sponsor ID
- 20/00912
- Conditions
- Calcaneus Fracture
- Keywords
- Calcaneal fracture, Subtalar arthroscopy, Trauma, Calcaneus
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Collaborators
- Oslo University Hospital, Haukeland University Hospital, Vestre Viken Hospital Trust
- Study start
- 5 May 2020 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this randomized controlled trial, the outcomes of two surgical techniques for intraarticular calcaneal fractures will be evaluated and compared.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Two-arm parallel assignment. Patients er randomized to operative treatment with either the sinus tarsi approach or percutaneous and arthroscopically assisted osteosynthesis.
| Arm | Type | Receives |
|---|---|---|
| Sinus tarsi approach (STA) | Active comparator | Procedure: Sinus tarsi approach (STA)Patients randomized to this arm are operated with plate osteosynthesis via the sinus tarsi approach |
| Percutaneous Arthroscopically Assisted Osteosynthesis (PACO) | Active comparator | Procedure: Percutaneous Arthroscopically Assisted Osteosynthesis (PACO)Patients randomized to this arm are operated with percutaneous reduction of the fracture and osteosynthesis with screws, assisted by subtalar arthroscopy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sinus tarsi approach (STA)Osteosynthesis | Procedure or surgery | Sinus tarsi approach (STA) |
| Percutaneous Arthroscopically Assisted Osteosynthesis (PACO)Osteosynthesis | Procedure or surgery | Percutaneous Arthroscopically Assisted Osteosynthesis (PACO) |
Primary outcome
Manchester-Oxford Foot Questionnaire (MOxFQ)
Time frame: 5 years
Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome)
8 secondary outcomes
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score
Time frame: 5 years
Calcaneus Fracture Scoring System (CFSS)
Time frame: 5 years
Self-reported foot and ankle score (SEFAS)
Time frame: 5 years
Visual Analogue Scale (VAS) for pain
Time frame: 5 years
Incidence of complications
Time frame: 5 years
Böhler angle
Time frame: 5 years
Subtalar osteoarthritis
Time frame: 5 years
EQ-5D-5L
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
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Calcaneal Angles And Postoperative Body Balance Following Internal Fixation
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Enhancing Wound Perfusion in High-Risk Lower Extremity Orthopaedic Surgery: A Study on Nitropaste Using Intraoperative SPY Imaging.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Are Stødle, MD principal investigator
Oslo University Hospital
Frede Frihagen, MD, PhD principal investigator
Ostfold Hospital Trust
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sinus tarsi approach (STA) and Percutaneous Arthroscopically Assisted Osteosynthesis (PACO) in people with Calcaneus Fracture, run by Ostfold Hospital Trust at 5 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manchester-Oxford Foot Questionnaire (MOxFQ) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.