Surgical Plate Osteosynthesis of Distal Radius Fractures

AO Clinical Investigation and Publishing Documentation

Status and phase: Terminated; Phase 4

Conditions: Distal Radius Fractures

Treatments: Device: Locking Compression Plate 3,5mm; Device: Locking Compression Plate 2,4mm

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00205998

01-LCP2,4/3,5-03

Details and patient eligibility

About

Primary objective of the study is to demonstrate specific indications for the

surgical treatment of distal radius fractures using the locking compression

plate.

Full description

In addition the differences between the surgical treatment compared to

conservative treatment with respect to fracture healing, functional outcome

and subject satisfaction will be analysed after 6w./6m./1y./2y.

Enrollment: 450 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• skeletally mature female and male
• Distal radius and ulnar fractures AO 23
• 10 days after injury

Exclusion criteria

• general or local conditions adversely affecting the bone physiology
• ISS >16
• osteosynthesis close to the wrist joint where a different implant has been used
• history of drug and alcohol abuse

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)