A prospective randomized moncenter trial comparing the clinical, functional and psychosocial outcome after treatment of syndesmosis ruptures with a static syndesmotic screw fixation or TightRope.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00013562

Enrollment

Registered

2017-12-07

Start date

2017-12-07

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

S82.4 S82.8

Interventions

Group 1: Patients with syndesmosis rupture and implantation of static syndesmotic screw fiaxtion Group 2: Patients with syndesmosis rupture and implantation of "Tight Rope"

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients of full age with a syndesmosis rupture

Exclusion criteria

Exclusion criteria: younger than 18, approval disability, congenital deformity, missing approval, contraindication for MRI

Design outcomes

Primary

Measure	Time frame
postoperative outcome measurement with several questionnaires and x-rays after 6 weeks, 3, 6 and 12 months: "Fragebogen zum Vergleich Stellschraube vs TightRope" "SF-12" "Score of Olerud and Molander" "VAS visual pain scale" "Foot and ankle outcome score" Outcome measurement with MRI only 3 months postoperatively	—

Secondary

Measure	Time frame
postoperative measurement and comparison of the long term outcome in x-ray 6 weeks, 3, 6 and 12 months after implantation of screws or TightRope additionally with an MRI 3 months postoperatively and as appropriate with gait analysis	—

Countries

Germany

Contacts

Public ContactJulian Doll

Zentrum für Orthopädie, Unfallchirurgie und Paraplegiologie

julian.doll@med.uni-heidelberg.de062215636388

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 26, 2026