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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
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: 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 November 24, 2014