Ziptight or Tricortical Screw Fixation of Acute Tibiofibular Syndesmotic Injury

Ankle Fractures Clinical Trial

— S16  

Official title:

Ziptight or Tricortical Screw Fixation of Acute Tibiofibular Syndesmotic Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02930486
• Other study ID #: Syndesmose2016
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: October 2019

Study information

• Verified date: November 2019
• Source: Vestre Viken Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Treatment of syndesmotic injury with Weber C fracture. A randomized study comparing ZipTight suture endobutton and one tricortical 3,5 mm syndesmotic screw.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2019
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fractures
• Ankle Injuries

Intervention

Device:
• ZipTight suture endobutton
Zimmer Biomet ZipTight suture endobutton
• Tricortical 3.5 mm syndesmotic screw
Depuy Synthes 3.5 mm screw

Locations

Country	Name	City	State
Norway	Baerum Hospital, Vestre Viken	Sandvika	Gjettum

Sponsors (3)

Lead Sponsor	Collaborator
Vestre Viken Hospital Trust	Oslo University Hospital, Ostfold Hospital Trust

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	24 months
Secondary	Manchester-Oxford Foot questionnaire (MOxFQ)		24 months
Secondary	Dorsiflexion angle	according to Lindsjø	24 months
Secondary	Health-related quality of life (EQ-5D)		24 months
Secondary	CT measurements of syndesmotic distance		24 months
Secondary	VAS	visual analogue scale	24 months