Mallet Finger Splinting Study

Mallet Finger Clinical Trial

Official title:

Night Splinting After 6 to 8 Weeks of Continuous Splinting for Mallet Finger

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01388751
• Other study ID #: 2008P001506
• Status: Completed
• Phase: N/A
• First received: July 5, 2011
• Last updated: October 30, 2012
• Start date: November 2008
• Est. completion date: September 2012

Study information

• Verified date: October 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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)?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mallet Finger

Intervention

Procedure:
• night splinting
splint finger at night for 4 weeks

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extensor Lag	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.	4 months	No
Secondary	DASH score	Secondary Study Questions: Is night splinting a predictor of DASH score or patient satisfaction (on a 5-Point Likert scale)?	4 months	No