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Mallet Finger Splinting Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01388751
First Posted: July 7, 2011
Last Update Posted: October 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital
  Purpose

Do patients that night splint for 1 month after 6-8 weeks of continuous splinting for a mallet injury have the same extensor lag 4 months after initiating treatment as patients that do not perform night splinting?

Secondary Question: Is night splinting a predictor of DASH score or patient satisfaction (on a 5-Point Likert scale)?


Condition Intervention
Mallet Finger Procedure: night splinting

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Night Splinting After 6 to 8 Weeks of Continuous Splinting for Mallet Finger

Further study details as provided by David C. Ring, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Extensor Lag [ Time Frame: 4 months ]

    Null Hypothesis:

    Patients that night splint for 1 month after 6-8 weeks of continuous splinting for a mallet injury have the same extensor lag 4 months after initiating treatment as patients that do not perform night splinting.



Secondary Outcome Measures:
  • DASH score [ Time Frame: 4 months ]

    Secondary Study Questions:

    Is night splinting a predictor of DASH score or patient satisfaction (on a 5-Point Likert scale)?



Enrollment: 52
Study Start Date: November 2008
Study Completion Date: September 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: no night splinting
Active Comparator: night splinting
Night Splinting for 4 weeks after removal of initial cast
Procedure: night splinting
splint finger at night for 4 weeks

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All adult, English-speaking patients in the practice of Dr. Jesse Jupiter, Dr. Chaitanya Mudgal, or Dr. David Ring electing splint treatment for mallet deformity will be invited to enroll on their follow-up visit 6-8 weeks after initiating splint treatment.

Exclusion Criteria:

  1. Open lesions
  2. Mallet fracture more than 2 weeks old
  3. Mallet fracture with subluxation of the distal interphalangeal joint.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01388751


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: David Ring, MD, PhD Mass General Hospital
  More Information

Responsible Party: David C. Ring, MD, Principal Investigator; Director of Research, Hand Service, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01388751     History of Changes
Other Study ID Numbers: 2008P001506
First Submitted: July 5, 2011
First Posted: July 7, 2011
Last Update Posted: October 31, 2012
Last Verified: October 2012

Keywords provided by David C. Ring, MD, Massachusetts General Hospital:
Mallet Finger splinting