NCT01388751CompletedNot Applicable
Night Splinting After 6 to 8 Weeks of Continuous Splinting for Mallet Finger
Massachusetts General Hospital2 sites in 1 country52 target enrollmentStarted: November 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 52
- Locations
- 2
- Primary Endpoint
- Extensor Lag
Study Overview
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)?
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Open lesions
- •Mallet fracture more than 2 weeks old
- •Mallet fracture with subluxation of the distal interphalangeal joint.
Outcomes
Primary Outcomes
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 Outcomes
- DASH score(4 months)
Investigators
David C. Ring, MD
Principal Investigator; Director of Research, Hand Service
Massachusetts General Hospital
Study Sites (2)
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