Surgical Plate Osteosynthesis of Distal Radius Fractures

Phase 4TerminatedNCT00205998

AO Clinical Investigation and Publishing Documentation450 enrolled

Overview

Primary objective of the study is to demonstrate specific indications for the surgical treatment of distal radius fractures using the locking compression plate.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

450

Conditions

Distal Radius Fractures

Interventions

Locking Compression Plate 2,4mmDEVICE

Locking Compression Plate 3,5mmDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (3)

Harvard Medical School

Boston, Massachusetts, United States

BG-Unfallklinik Ludwigshafen

Ludwigshafen, Germany

York District Hospital

York, United Kingdom

Outcomes

Primary Outcomes

- Document specific indications for the surgical treatment of distal radius fractures using the LCP

Secondary Outcomes

- Primary reduction and maintenance of reduction of the plate fixation

- Functional outcome scoring using "Garetland and Werley, DASH and SF-36 scoring

- Patient and surgeon satisfaction

- Analysis of the occured complications

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.