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Osteosynthesis of Intraarticular Calcaneal Fractures: Arthroscopically Assisted Percutaneous Technique Versus Sinus Tarsi Approach

Primary Purpose

Calcaneus Fracture

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Sinus tarsi approach (STA)
Percutaneous Arthroscopically Assisted Osteosynthesis (PACO)
Sponsored by
Ostfold Hospital Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Calcaneus Fracture focused on measuring Calcaneal fracture, Subtalar arthroscopy, Trauma, Calcaneus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Haukeland University HospitalRecruiting
  • Vestre Viken Hospital Trust - Drammen hospitalRecruiting
  • Oslo university hospialRecruiting
  • Vestre Viken Hospital Trust - Bærum hospitalRecruiting
  • Østfold Hospital TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sinus tarsi approach (STA)

Percutaneous Arthroscopically Assisted Osteosynthesis (PACO)

Arm Description

Patients randomized to this arm are operated with plate osteosynthesis via the sinus tarsi approach

Patients randomized to this arm are operated with percutaneous reduction of the fracture and osteosynthesis with screws, assisted by subtalar arthroscopy

Outcomes

Primary Outcome Measures

Manchester-Oxford Foot Questionnaire (MOxFQ)
Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome)

Secondary Outcome Measures

American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score
Widely used foot/ankle score (0-100 with 100 representing the best possible outcome)
Calcaneus Fracture Scoring System (CFSS)
Calcaneal fracture specific scoring system (0-100 with 100 representing the best possible outcome)
Self-reported foot and ankle score (SEFAS)
Foot-Ankle specific PROM (0-48 with 48 representing the best possible outcome)
Visual Analogue Scale (VAS) for pain
Scores pain at rest and on activity (0-10 with 0 representing no pain)
Incidence of complications
Yes/no for deep or superficial infection, nerve or tendon injury, deep venous thrombosis, hardware complaints and secondary surgery
Böhler angle
Böhler angle pre- and post surgery as well as at follow up
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.
EQ-5D-5L
Measure of health-related quality of life. This will be evaluated at the 2-year and 5 -year follow-up.

Full Information

First Posted
April 29, 2020
Last Updated
May 11, 2022
Sponsor
Ostfold Hospital Trust
Collaborators
Oslo University Hospital, Haukeland University Hospital, Vestre Viken Hospital Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04372251
Brief Title
Osteosynthesis of Intraarticular Calcaneal Fractures: Arthroscopically Assisted Percutaneous Technique Versus Sinus Tarsi Approach
Official Title
Osteosynthesis of Intraarticular Calcaneal Fractures: Arthroscopically Assisted Percutaneous Technique Versus Sinus Tarsi Approach - A Randomized Controlled Multicenter Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2020 (Actual)
Primary Completion Date
December 2030 (Anticipated)
Study Completion Date
December 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ostfold Hospital Trust
Collaborators
Oslo University Hospital, Haukeland University Hospital, Vestre Viken Hospital Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcaneus Fracture
Keywords
Calcaneal fracture, Subtalar arthroscopy, Trauma, Calcaneus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Investigator
Masking Description
The investigators that will conduct the follow-up examinations 2 and 5 years after surgery will be blinded for the operative treatment.
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sinus tarsi approach (STA)
Arm Type
Active Comparator
Arm Description
Patients randomized to this arm are operated with plate osteosynthesis via the sinus tarsi approach
Arm Title
Percutaneous Arthroscopically Assisted Osteosynthesis (PACO)
Arm Type
Active Comparator
Arm Description
Patients randomized to this arm are operated with percutaneous reduction of the fracture and osteosynthesis with screws, assisted by subtalar arthroscopy
Intervention Type
Procedure
Intervention Name(s)
Sinus tarsi approach (STA)
Intervention Description
Osteosynthesis
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Arthroscopically Assisted Osteosynthesis (PACO)
Intervention Description
Osteosynthesis
Primary Outcome Measure Information:
Title
Manchester-Oxford Foot Questionnaire (MOxFQ)
Description
Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome)
Time Frame
5 years
Secondary Outcome Measure Information:
Title
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score
Description
Widely used foot/ankle score (0-100 with 100 representing the best possible outcome)
Time Frame
5 years
Title
Calcaneus Fracture Scoring System (CFSS)
Description
Calcaneal fracture specific scoring system (0-100 with 100 representing the best possible outcome)
Time Frame
5 years
Title
Self-reported foot and ankle score (SEFAS)
Description
Foot-Ankle specific PROM (0-48 with 48 representing the best possible outcome)
Time Frame
5 years
Title
Visual Analogue Scale (VAS) for pain
Description
Scores pain at rest and on activity (0-10 with 0 representing no pain)
Time Frame
5 years
Title
Incidence of complications
Description
Yes/no for deep or superficial infection, nerve or tendon injury, deep venous thrombosis, hardware complaints and secondary surgery
Time Frame
5 years
Title
Böhler angle
Description
Böhler angle pre- and post surgery as well as at follow up
Time Frame
5 years
Title
Subtalar osteoarthritis
Description
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.
Time Frame
5 years
Title
EQ-5D-5L
Description
Measure of health-related quality of life. This will be evaluated at the 2-year and 5 -year follow-up.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wolfram Grün, MD
Phone
+4741297874
Email
wolframgruen@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marius Molund, MD, PhD
Phone
+4790093988
Email
mariusmolund@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Are Stødle, MD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frede Frihagen, MD, PhD
Organizational Affiliation
Ostfold Hospital Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gard Kristian Anderssen, MD
Email
gard.kristian.anderssen@helse-bergen.no
Facility Name
Vestre Viken Hospital Trust - Drammen hospital
City
Drammen
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erik Bjørbæk, MD
Email
B30957@vestreviken.no
Facility Name
Oslo university hospial
City
Oslo
ZIP/Postal Code
0588
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wolfram Grün, MD
Phone
+4741297874
Email
wolframgruen@hotmail.com
First Name & Middle Initial & Last Name & Degree
Are Stødle, MD
Phone
+4797174507
Email
arhauk@ous-hf.no
First Name & Middle Initial & Last Name & Degree
Elisabeth Ellingsen Husebye, MD, PhD
Facility Name
Vestre Viken Hospital Trust - Bærum hospital
City
Sandvika
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Espen Laudal, MD
Email
eslaud@vestreviken.no
Facility Name
Østfold Hospital Trust
City
Sarpsborg
State/Province
Østfold
ZIP/Postal Code
1714
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marius Molund, MD, PhD
Phone
+4790093988
Email
marius.molund@so-hf.no
First Name & Middle Initial & Last Name & Degree
Fredrik Nilsen, MD
Email
fredni@so-hf.no

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Osteosynthesis of Intraarticular Calcaneal Fractures: Arthroscopically Assisted Percutaneous Technique Versus Sinus Tarsi Approach

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