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Treatment of reducible unstable fractures of the distal extremity of the radius: external fixation versus percutaneous pinning

Treatment of reducible unstable fractures of the distal extremity of the radius: external fixation versus percutaneous pinning - a randomised clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN04892785
Enrollment
100
Registered
2009-12-02
Start date
2002-03-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Colles' fracture Injury, Occupational Diseases, Poisoning Fracture of forearm

Interventions

Transulnar percutaneous pinning (De Palma) versus bridging external fixation. The total duration of follow-up was 2 years.

Sponsors

Federal University of Sao Paulo (Brazil)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The patients were adults aged over 40 years (either sex) who presented with acute fractures with displacement up to 10 days old without previous treatment. The fractures were categorised using the Cooney classification 10 as unstable and reducible: type IIb and type IVb. Fractures were considered unstable if they presented three or more of the following factors at the initial radiographic examination: 1. Shortening of the radius by more than 5 mm 2. Dorsal angulation greater than 20 degrees 3. Joint incongruence 4. Fracture associated with the styloid process of the ulna 5. Dorsal comminution of the metaphysis 6. Aged greater than 60 years

Exclusion criteria

Exclusion criteria: 1. Fractures with volar angulation (Smith fracture) 2. Joint margin fractures (Barton fracture) 3. Open or bilateral fractures 4. Fractures that could not be reduced 5. Patients with previous histories of degenerative disease, wrist joint trauma, or traumatic injuries associated with the fracture that would make it impossible to apply the proposed surgical methods or evaluate the results 6. Patients who refused to sign the free and informed consent statement

Design outcomes

Primary

MeasureTime frame
Measured at 6 months and 2 years: 1. Disability Arm Shoulder and Hand questionare (DASH) 2. Visual Analogue Scale (VAS)

Secondary

MeasureTime frame
Measured at 6 months and 2 years: 1. Radiographic outcomes: radiographs in posteroanterior and lateral views were used for evaluation, and the following parameters were measured: volar inclination angle, radial inclination angle, presence of a stepped joint and consolidation. 2. Objective functional assessment: range of motion and grip 3. Complications and failures Functional and radiographic evaluations, pain measurements using the VAS, and applications of the DASH questionnaire were performed by professional orthopedists and physiotherapists who were not directly associated with the study

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 31, 2026