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A clinical study of sensor-assisted precise dynamic compression and staged plaster fixation for the treatment of distal radius fractures

A clinical study of sensor-assisted precise dynamic compression and staged plaster fixation for the treatment of distal radius fractures

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124801
Enrollment
Unknown
Registered
2026-05-18
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-05-25

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

Conditions

Distal radius fractures

Interventions

Experimental group:Sensor-assisted precise dynamic compression plaster fixation. A FlexiForce A201 flexible thin-film pressure sensor (measurement range 0-2.5 N/cm2, accuracy ±5%) is calibrated with s
if repeated attempts fail to achieve target, perform X-ray and consider recasting. All patients receive standardized staged plaster: 3 weeks of forearm U-shaped cast followed by 3 weeks of short-arm c
Control group:Conventional empirical plaster adjustment. No pressure sensor is used. A standard 2mm-thick cotton pad is placed at the same anatomical location and fixed with tape. At the same time poi
cast too tight if persistent numbness, capillary refill time >2 seconds, severe pain, or tension blisters ? remove 1-2 layers of bandage or split/remake cast
normal if 1 finger can be inserted without neurovascular compromise ? no adjustment. Cast protocol, hospitalization, and fo

Sponsors

Shanghai Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 78 Years

Inclusion criteria

Inclusion criteria: 1.Unilateral distal radius fracture, Fernandez type I or II; 2.Age between 60 and 78 years (inclusive); 3.Time from injury =7 days; 4.Successful closed reduction with post-reduction radiographs meeting all of the following criteria: radial height loss <2mm, palmar tilt loss <5°, ulnar deviation loss <5°, articular step <1mm; 5.Willing to be hospitalized for 7-10 days for standardized monitoring and complete 12-month follow-up; 6.Able to understand and comply with study procedures; 7.Provide written informed consent; 8.No use of active anti-osteoporosis medication within 3 months before injury, or willing to maintain consistent anti-osteoporosis treatment during the study period.

Exclusion criteria

Exclusion criteria: 1.Concomitant fractures of the same upper extremity (scaphoid, ulna, humerus); 2.Severe soft tissue injury (Gustilo grade =II), vascular injury, or nerve injury requiring surgical treatment; 3.Severe medical diseases (uncontrolled hypertension, diabetes with complications, severe heart/lung/kidney disease) or psychiatric disorders that prevent cooperation with the study; 4.Severe wrist dysfunction due to previous injury or arthritis (Gartland-Werley score >10); 5.Pathological fracture due to malignancy or infection; 6.Participation in other clinical trials within the previous 3 months; 7.Known allergy to plaster, cotton materials, or medical tape.

Design outcomes

Primary

MeasureTime frame
Fracture redisplacement rate;

Secondary

MeasureTime frame
Gartland-Werley wrist function score;Visual Analog Scale (VAS) pain score;Complication rate;Surgical conversion rate;

Countries

China

Contacts

Public ContactWu Haiyang

Shanghai Second People's Hospital

286948197@qq.com+86 21 2330 8990

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026