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Completed

NCT Number: NCT01275924

Tightrope or Screw Fixation of Acute Tibiofibular Syndesmotic Injury

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 Tightrope Syndesmosis Repair Kit (Arthrex; Naples, Florida). is used for the same indication, it consists of a heavy suture placed across the syndesmosis which has been looped and tightened through cortical button anchors on either side of the ankle. It does not need removal and thus avoids subsequent surgery. This trial compares these two treatment methods for syndesmotic injuries of the ankle.

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Key information

Conditions

Syndesmotic Injury of the Ankle Fractures, Bone Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital, Oslo, Norway

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About this study

Patients 18-70 years presenting to one of the two hospitals with an acute syndesmotic injury are eligible for inclusion. 50 patients are randomised to two treatment groups: One group receives a Tightrope (R) fixation and the other receives a quadricortical screw fixation which is removed after 12 weeks. Follow-up intervals are at 6 weeks, 6, 12 and 24 months with standardised CT scans postoperatively and at 12, 24 months and 5 years clinical end-ponts/scores.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 to 70 years
  • Acute syndesmotic injury with or without Weber type C fracture

Exclusion criteria

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

Treatment and study plan

Tightrope Syndesmosis Repair Kit

Device

Tightrope Syndesmosis Repair Kit

Other names: Tightrope Syndesmosis Repair Kit, Arthrex; Naples, Florida

Syndesmotic screw

Device

Quadricortical syndesmotic screw

Other names: Cortical screw; Synthes GmbH, Switzerland

Primary outcomes

  1. OTA Score (Modified American Orthopaedic Foot and Ankle Society ankle hind foot score)

    Time frame: 5 years

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

Secondary outcomes

  1. Olerud-Molander Ankle (OMA) Score

    Time frame: 5 years

  2. Dorsiflexion angle

    Time frame: 5 years

    According to Lindsjø

  3. Health-related quality of life (EQ-5D)

    Time frame: 5 years

  4. CT measurements of syndesmotic distance

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Sykehuset Asker og Baerum

Other

Collaborators

  • Oslo University Hospital

Registry information

Official study title

Tightrope or Screw Fixation of Acute Tibiofibular Syndesmotic Injury. Randomised Controlled Trial.

Acronym: TIGHTROPE-SS

Important dates

Study start
2011
Primary completion
2015
Study completion
2018
First posted
Jan 13, 2011
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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