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Completed

NCT Number: NCT01156766

Metaphyseal Distal Radius Fractures

The number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques are described in particular locking plates and intrafocal pinning techniques.

The aim of the study is to compare (X-ray assessments and functional outcome) these two types of treatment by using a prospective, randomised multicentric analysis.

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Key information

Conditions

Metaphyseal Radius Fractures (AO Type A2, A3, C1 et C2) Fractures, Bone Wounds and Injuries

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

Because an increasing number of elderly patient, the number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques exist of which in particular locking plates and intrafocal pinning.

The availability of new materials (locking plates with angular stability) seems to reduce the risks of osteosynthesis failure and seems to give more constant results: hawever, the price to pay is a more invasive technique and a superior cost. The rehabilitation seems also faster, allowing the possibility to get back the maximum of autonomy.

These clinical facts need of course to be validated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - metaphyseal inferior radius fractures (AO classification 23A2, 23A3, 23C1, 23C2)
  • age 60 years or older

Exclusion criteria

  • open fracture
  • fractures AO classification: 23A1, 23C3, 23B1, 23B2, 23B3
  • polytraumatized patient
  • fractures older than 15 days
  • infection of the operating site
  • previous osseous disease

Treatment and study plan

- locking anterior plate

Device

The number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques are described in particular locking plates and intrafocal pinning techniques.

The aim of the study is to compare (X-ray assessments and functional outcome) these two types of treatment by using a prospective, randomised multicentric analysis.

Primary outcomes

  1. - X-ray assessments (preoperative, postoperative; 2 weeks, 5 weeks, 3, 6 and 12 mouths)

    Time frame: preoperative, postoperative; 2 weeks, 5 weeks, 3, 6 and 12 mouths

Secondary outcomes

  1. PAIN score (2 weeks, 5 weeks, 3, 6 and 12 months)

    Time frame: 2 weeks, 5 weeks, 3, 6 and 12 months

  2. Gartland, O'Brien, DASH and Euroquol EQ-5D scores (5 weeks, 3, 6 and 12 months)

    Time frame: 5 weeks, 3, 6 and 12 months

  3. Grip and pinch strength (5 weeks, 3, 6 and 12 months)

    Time frame: 5 weeks, 3, 6 and 12 months

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Polyclinique du Parc Rambot
  • Stryker SA

Registry information

Official study title

Locking Plate Versus Pins for Surgical Treatment of Posteriorly Tilted Distal Radius Fracture

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 5, 2010
Registry last updated
Jun 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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