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

July 5, 2011
October 30, 2012
November 2008
May 2012   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01388751 on ClinicalTrials.gov Archive Site
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)?

Same as current
Not Provided
Not Provided
 
Mallet Finger Splinting Study
Night Splinting After 6 to 8 Weeks of Continuous Splinting for Mallet Finger

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)?

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Mallet Finger
Procedure: night splinting
splint finger at night for 4 weeks
  • No Intervention: no night splinting
  • Active Comparator: night splinting
    Night Splinting for 4 weeks after removal of initial cast
    Intervention: Procedure: night splinting
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
September 2012
May 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01388751
2008P001506
Yes
David C. Ring, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: David Ring, MD, PhD Mass General Hospital
Massachusetts General Hospital
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP