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Mallet Finger Splinting Study

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ClinicalTrials.gov Identifier: NCT01388751
Recruitment Status : Completed
First Posted : July 7, 2011
Last Update Posted : October 31, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Mallet Finger Procedure: night splinting

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
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
Study Start Date : November 2008
Primary Completion Date : May 2012
Study Completion Date : September 2012
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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)?



Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: July 7, 2011    Key Record Dates
Last Update Posted: October 31, 2012
Last Verified: October 2012

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