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Completed

NCT Number: NCT00955734

Early Motion After Volar Fixation for Distal Radius Fractures

Many surgeons pursue volar plating of the distal radius to allow earlier post-operative wrist motion. Early motion is generally prescribed in the belief that it will result in greater final motion without compromising fixation. However, studies have failed to demonstrate clinically significant improvement in final wrist motion (> 1 year follow up) compared to treatments requiring longer immobilization such as external fixation or bridge plating.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

Many surgeons pursue volar plating of the distal radius to allow earlier post-operative wrist motion. Early motion is generally prescribed in the belief that it will result in greater final motion without compromising fixation. However, studies have failed to demonstrate clinically significant improvement in final wrist motion (>1 year follow up) compared to treatments requiring longer immobilization such as external fixation or bridge plating (McQueen 1996, Handoll 2003, Atroshi 2006, Krishnan 2003, Sommerkamp 1994, Grewal 2005).

Only one study to date has attempted to define the early effects of wrist mobilization following volar plate fixation of the distal radius (Lozano-Calderon 2008). That study prospectively enrolled 60 patients and randomized them to begin wrist motion at 2 weeks (range 7 days - 13 days) or 6 weeks (range 42 to 49 days) postoperatively. This study found no significant difference in subjective or objective outcome measures at 3 or 6 months follow up. However, the investigation had several weaknesses. First, there was no attempt to confirm adherence to the immobilization protocols. Those in the late motion group were not casted but remained in orthoplast splints which could be easily removed. Secondly, this investigation collected data only at 3 and 6 months which prohibited them from commenting on the rate of improvement during the early weeks after mobilization. The authors acknowledged these limitations and further noted that no evaluation of patient cost was performed. Finally, radiographic evaluations in this study did not include analysis of change in alignment from immediate postoperative films.

Thus, the literature to date suggests that early mobilization of the volarly plated distal radius is safe but does not improve final wrist motion. The benefits of mobilization in the early postoperative period though have not been clearly defined. This project proposes to fill this void in the literature and determine if early mobilization is an effective measure to hasten recovery of motion and function.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults over 18 years of age having volar internal fixation for distal radius fractures.

Exclusion criteria

  • Patients will be excluded if immobilization is required for distal radioulnar joint instability (whether operatively pinned or simply immobilized in supination) or an associated carpal injury.
  • Patients with concurrent fracture of the ulna proximal to the base of the ulnar styloid will be excluded.

Treatment and study plan

Early Motion

Other

One set of patients will begin wrist motion at 1 week after surgery.

Immobilization

Other

This set of patients will be casted for 6 weeks after surgery.

Primary outcomes

  1. Wrist Motion

    Time frame: 2 weeks - 1 year

Secondary outcomes

  1. Patient Function

    Time frame: 2 weeks - 1 year

  2. Patient Pain

    Time frame: 2 weeks - 1 year

  3. Fracture reduction

    Time frame: 2 week - 1 year

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Early Motion After Volar Fixation for Distal Radius Fractures: A Prospective Trial

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Aug 10, 2009
Registry last updated
Jun 29, 2015

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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