Early Motion After Volar Fixation for Distal Radius Fractures

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00955734
First received: August 7, 2009
Last updated: March 14, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Radius Fracture
Other: Early motion
Other: Immobilization

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Motion After Volar Fixation for Distal Radius Fractures: A Prospective Trial

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Wrist Motion [ Time Frame: 2 weeks - 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient Function [ Time Frame: 2 weeks - 1 year ] [ Designated as safety issue: No ]
  • Patient Pain [ Time Frame: 2 weeks - 1 year ] [ Designated as safety issue: No ]
  • Fracture reduction [ Time Frame: 2 week - 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: June 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early motion
This group of patients will begin wrist motion 1 week after surgery.
Other: Early motion
One set of patients will begin wrist motion at 1 week after surgery.
Active Comparator: Immobilization
This group will be casted for 6 weeks after surgery
Other: Immobilization
This set of patients will be casted for 6 weeks after surgery.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955734

Locations
United States, Missouri
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Ryan Calfee, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Ryan Calfee, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00955734     History of Changes
Other Study ID Numbers: 09-0566
Study First Received: August 7, 2009
Last Updated: March 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
wrist
fracture
motion
surgery

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries

ClinicalTrials.gov processed this record on August 28, 2014