Deltoid ligament augmentation technique replacing syndesmosis fixation for the treatment of ankle fracture: a multicenter prospective clinical study

The biomechanical and clinical study of insertion and tightening methods in deltoid ligament augmentation technique

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200064490

Enrollment

Unknown

Registered

2022-10-10

Start date

2022-10-20

Completion date

Unknown

Last updated

2023-05-15

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

Conditions

ankle fracture

Interventions

Experimental group:deltoid ligament augmentation replacing syndesmosis fixation

Eligibility

Sex/Gender

All

Age

16 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 16-70 years; 2. Ankle fracture without medial malleolus fracture, complete triangular ligament injury (preoperative X-ray indicated medial malleolus space widening >=5mm, or medial malleolus space widening >=5mm at malleolus point in intraoperative external rotation stress test) and inferior tibiofibular injury (intraoperative hook test or external rotation test lower tibiofibular space widening at malleolus point > 2mm); 3. The injury is less than 2 weeks.

Exclusion criteria

Exclusion criteria: 1. Posterior malleolar fractures requiring fixation (articular step >=2mm or bone mass in lateral position exceeding 25% of articular surface); 2. Combined with ankle joint deformity, old injury or instability; 3. Multiple fractures; 4. Combined with ipsilateral talus, calcaneus and foot fractures; 5. Open fracture; 6. Pathological fracture.

Design outcomes

Primary

Measure	Time frame
Ankle function score at 1 year after surgery (AOFAS);The short form health survey (SF-36) was scored one year after operation;Radiographic parameters;	—

Countries

China

Contacts

Public ContactLi Ting

Beijing Jishuitan Hospital

liting2000@sina.com+86 13910084939

Outcome results

None listed

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