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Comparative Efficacy of an Integrated Percutaneous Kirschner Wire Fixation System versus Volar Locking Plate Fixation for Complex Distal Radius Fractures in Patients Aged =50 Years: A Non-inferiority Randomized Controlled Trial

Comparative Efficacy of an Integrated Percutaneous Kirschner Wire Fixation System versus Volar Locking Plate Fixation for Complex Distal Radius Fractures in Patients Aged =50 Years: A Non-inferiority Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122344
Enrollment
Unknown
Registered
2026-04-13
Start date
2026-04-25
Completion date
Unknown
Last updated
2026-04-20

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

Conditions

Distal Radius Fracture

Interventions

Experimental group (Integrated K-wire System)::Closed reduction and percutaneous K-wire fixation
Control group (Volar Locking Plate Internal Fixation): open reduction and locking plate fixation

Sponsors

Wendeng Orthopedics Hospital of Shandong
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age = 50 years. 2.Fresh closed distal radius fracture (injury = 14 days) classified radiologically as AO/OTA 23A3, 23B2–B3, or 23C1–C3. 3.Acceptable reduction can be obtained and maintained under fluoroscopy after closed manipulation (manual or traction, with external finger-trap distraction if necessary) under anesthesia. 4.Able to understand the study information, provide written informed consent, and guarantee 12-month follow-up.

Exclusion criteria

Exclusion criteria: 1. Open fracture (Gustilo types I–III). 2.Associated neurovascular injury requiring emergency repair. 3. Previous wrist surgery or fracture in the ipsilateral limb. 4. Pathological fracture (e.g., tumor) or severe metabolic bone disease (osteoporosis excluded). 5. Severe medical comorbidities or coagulopathy precluding surgery. 6. Concurrent ipsilateral upper-limb fractures that would interfere with functional assessment. 7. Cognitive impairment, psychiatric disorder, or inability to comply with follow-up.

Design outcomes

Primary

MeasureTime frame
Disabilities of the Arm, Shoulder and Hand Score;Patient-Rated Wrist Evaluation Score;

Secondary

MeasureTime frame
Postoperative radiographic alignment parameters;Complication rates;Intraoperative blood loss;operative time; length of hospital stay; in-patient costs;Range of Motion(ROM);

Countries

China

Contacts

Public ContactJunwei Zhang

Wendeng Orthopedics Hospital of Shandong

15806314586@163.com+86 631 848 2109

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026