Comparison of the results of two treatment systems in ankle injuries

Clinical and functional results of screws and TighRope Knotless device in the treatment of syndesmosis acute injuries: a randomized controlled trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN71276902

Enrollment

100

Registered

2021-11-01

Start date

2019-04-01

Completion date

Unknown

Last updated

2021-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of syndesmosis injury Musculoskeletal Diseases

Interventions

During surgery, once bone fractures have been fixed, the lesion of syndesmosis is verified by performing an external rotation stress test with the radiological study. If the patient suffers a syndesmo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients over 16 years all with physis closed 2. Patients with acute isolated syndesmosis disruption and patients with ankle fracture associated with syndesmosis disruption

Exclusion criteria

Exclusion criteria: 1. Patients with physis opened 2. Patients with previus injuries about ankle 3. Patients unable to perform postoperative treatment adequately

Design outcomes

Primary

Measure	Time frame
1. Pain is measured using Visual Analogue Scale (VAS) at 3, 6 and 12 months 2. Functional outcome is measured using AOFAS Scale and Olerud-Molander scale at 3, 6 and 12 months	—

Secondary

Measure	Time frame
1. Ankle range motion measured using manual goniometer at 3, 6 and 12 months 2. Syndesmosis reduction measured usind rx at 3, 6 and 12 months and CT at baseline 3. Complications are collected during follow-up	—

Countries

Spain

Contacts

Public ContactPatricia Morales

patrmorales@hotmail.com+34 620296088

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026