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OpenTrials
Completed

NCT Number: NCT00438308

Comparison of Early and Late Therapy for Adults With Operatively Treated Distal Radius Fractures

The purpose of the study is to compare two common ways of rehabilitating after surgery for distal radius fractures treated operatively with a volar plate.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Over the last three decades, operative treatment of distal radius fractures has become increasingly common compared to non-operative treatment. Over the last 15 years there has been a trend towards more invasive, internal plate fixation of fractures of the distal radius. One argument in favor of internal fixation for these fractures is that, similar to other periarticular fractures, it would be beneficial to allow early movement of the wrist articulation. There is not, however, any data to support this statement. In fact, data regarding external fixation that either immobilizes the wrist or allows wrist motion suggest that early wrist mobilization is not as important as the overall alignment of the bone in terms of final wrist motion. This question is important in patient care and in decision-making regarding these fractures. Additionally, many companies use this claim as a marketing point in spite of the lack of evidence. We consider that good quality data is needed to determine the answer to this issue and to help to resolve the related problems described above.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Gender: Male or female
  • Age: Older than 18
  • Isolated distal radial fracture
  • Fracture treated with volar plates, stable fixation
  • Initial treatment within 4 weeks of trauma

Exclusion criteria

  • Complex fractures that require additional or different material than volar plates
  • Unstable fractures in which early mobilization is contraindicated

Treatment and study plan

Primary outcomes

  1. range of motion in degrees of the wrists

    Time frame: 6 months

Secondary outcomes

  1. DASH score

    Time frame: 6 months

  2. Likert pain scale

    Time frame: 6 months

  3. pinch and grip strength

    Time frame: 6 months

  4. Gartland and Werely score

    Time frame: 6 months

  5. and Mayo wrist score

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Prospective Randomized Comparison of Early and Late Wrist Mobilization After Volar Plate Fixation of a Fracture of the Distal Radius

Important dates

Study start
2004
Study completion
2007
First posted
Feb 22, 2007
Registry last updated
Aug 12, 2010

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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