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

Vestre Viken Hospital Trust

Status: Completed

Conditions: Ankle Fractures

Treatments: Device: Tricortical 3.5 mm syndesmotic screw; Device: ZipTight suture endobutton

Study type: Interventional

Funder types: Other

Identifiers

NCT02930486

Syndesmose2016

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

ZipTight

Active Comparator group

Description:

ZipTight suture endobutton

Treatment:

Device: ZipTight suture endobutton

Syndesmotic screw

Active Comparator group

Description:

Tricortical 3.5 mm syndesmotic screw

Treatment:

Device: Tricortical 3.5 mm syndesmotic screw