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Ziptight or Tricortical Screw Fixation of Acute Tibiofibular Syndesmotic Injury (S16)

Primary Purpose

Ankle Fractures

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
ZipTight suture endobutton
Tricortical 3.5 mm syndesmotic screw
Sponsored by
Vestre Viken Hospital Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Fractures focused on measuring Syndesmosis, Injury, Ankle, Fracture, Weber C

Eligibility Criteria

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

Inclusion Criteria:

  • 18 to 70 years
  • Acute syndesmotic injury with Weber type C fracture

Exclusion Criteria:

  • Prior injury og the same ankle
  • Severe injury of the same leg affecting rehabilitation
  • Symptomatic osteoarthritis of same ankle
  • open injury
  • Decubital injury affecting surgical site
  • Dementia or unable to sign informed consent
  • neuropatic conditions affecting same leg

Sites / Locations

  • Baerum Hospital, Vestre Viken

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ZipTight

Syndesmotic screw

Arm Description

ZipTight suture endobutton

Tricortical 3.5 mm syndesmotic screw

Outcomes

Primary Outcome Measures

OTA Score (Modified American Orthopaedic Foot and Ankle Society ankle hind foot score)
Modified American Orthopaedic Foot and Ankle Society ankle hind foot score (0-100)

Secondary Outcome Measures

Manchester-Oxford Foot questionnaire (MOxFQ)
Dorsiflexion angle
according to Lindsjø
Health-related quality of life (EQ-5D)
CT measurements of syndesmotic distance
VAS
visual analogue scale

Full Information

First Posted
April 18, 2016
Last Updated
November 26, 2019
Sponsor
Vestre Viken Hospital Trust
Collaborators
Oslo University Hospital, Ostfold Hospital Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02930486
Brief Title
Ziptight or Tricortical Screw Fixation of Acute Tibiofibular Syndesmotic Injury
Acronym
S16
Official Title
Ziptight or Tricortical Screw Fixation of Acute Tibiofibular Syndesmotic Injury
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
October 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Treatment of syndesmotic injury with Weber C fracture. A randomized study comparing ZipTight suture endobutton and one tricortical 3,5 mm syndesmotic screw.
Detailed Description
Syndesmotic injuries are common and often associated with unstable ankle fractures. The most common treatment is with a syndesmotic screw through the fibula and tibia which is later removed, usually after 10-12 weeks. The ZipTight suture endobutton (Biomet) is used for the same indication. It does not need removal and thus avoids subsequent surgery. This trial will compare these two methods and see if they are equal. patients 18-70 years presenting to one of the three hospitals with and acute syndesmotic injury are eligible for inclusion. 120 patients are randomized to two treatment groups. One group will be treated with a ZipTight suture endobutton fixation and the other receives a tricortical screw fixation. Neither suture endobutton or screw is routinely removed. Follow up intervals are at 6 weeks, 6, 12 and 24 months with clinical and-points. Standardized CT scans are taken postoperatively and at 12 and 24 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fractures
Keywords
Syndesmosis, Injury, Ankle, Fracture, Weber C

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ZipTight
Arm Type
Active Comparator
Arm Description
ZipTight suture endobutton
Arm Title
Syndesmotic screw
Arm Type
Active Comparator
Arm Description
Tricortical 3.5 mm syndesmotic screw
Intervention Type
Device
Intervention Name(s)
ZipTight suture endobutton
Intervention Description
Zimmer Biomet ZipTight suture endobutton
Intervention Type
Device
Intervention Name(s)
Tricortical 3.5 mm syndesmotic screw
Intervention Description
Depuy Synthes 3.5 mm screw
Primary Outcome Measure Information:
Title
OTA Score (Modified American Orthopaedic Foot and Ankle Society ankle hind foot score)
Description
Modified American Orthopaedic Foot and Ankle Society ankle hind foot score (0-100)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Manchester-Oxford Foot questionnaire (MOxFQ)
Time Frame
24 months
Title
Dorsiflexion angle
Description
according to Lindsjø
Time Frame
24 months
Title
Health-related quality of life (EQ-5D)
Time Frame
24 months
Title
CT measurements of syndesmotic distance
Time Frame
24 months
Title
VAS
Description
visual analogue scale
Time Frame
24 months

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: 18 to 70 years Acute syndesmotic injury with Weber type C fracture Exclusion Criteria: Prior injury og the same ankle Severe injury of the same leg affecting rehabilitation Symptomatic osteoarthritis of same ankle open injury Decubital injury affecting surgical site Dementia or unable to sign informed consent neuropatic conditions affecting same leg
Facility Information:
Facility Name
Baerum Hospital, Vestre Viken
City
Sandvika
State/Province
Gjettum
ZIP/Postal Code
1346
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32907456
Citation
Raeder BW, Stake IK, Madsen JE, Frihagen F, Jacobsen SB, Andersen MR, Figved W. Randomized trial comparing suture button with single 3.5 mm syndesmotic screw for ankle syndesmosis injury: similar results at 2 years. Acta Orthop. 2020 Dec;91(6):770-775. doi: 10.1080/17453674.2020.1818175. Epub 2020 Sep 10.
Results Reference
derived

Learn more about this trial

Ziptight or Tricortical Screw Fixation of Acute Tibiofibular Syndesmotic Injury

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