Mallet Finger Splinting Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01388751
First received: July 5, 2011
Last updated: October 30, 2012
Last verified: October 2012
  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: 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 Massachusetts General Hospital:

Primary Outcome Measures:
  • Extensor Lag [ Time Frame: 4 months ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 5, 2011
Last Updated: October 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Mallet Finger splinting

ClinicalTrials.gov processed this record on April 17, 2014