Conservative Treatment of Mallet Finger Injury
Sponsor
Orthopaedic Specialty Group PC, Fairfield (Other)
Overall Status
Completed
CT.gov ID
NCT04830917
Collaborator
(none)
70
1
2
48.1
1.5
Study Details
Study Description
Brief Summary
Comparing outcomes of individuals treated with Kinesiotape and oval 8 versus quick cast for a conservatively managed mallet finger injury. Outcomes include DIP joint extension lag, patient satisfaction and function via the MHQ.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Randomized Clinical Trial Comparing Kinesiotape and Oval 8 to Quick Cast for Conservative Treatment of Mallet Finger Injury
Actual Study Start Date
:
Apr 24, 2017
Actual Primary Completion Date
:
Apr 28, 2021
Actual Study Completion Date
:
Apr 28, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment with Kinesiotape and Oval 8
|
Other: Immobilization type for mallet injury
Method to hold the DIP joint in full extension to allow healing of terminal tendon injury/mallet injury
|
| Experimental: Treatment with quick cast
|
Other: Immobilization type for mallet injury
Method to hold the DIP joint in full extension to allow healing of terminal tendon injury/mallet injury
|
Outcome Measures
Primary Outcome Measures
- Goniometric measurement of range of motion for distal interphalangeal joint extension lag at the involved digit [12 weeks from injury]
Secondary Outcome Measures
- Goniometric measurement of range of motion for distal interphalangeal joint extension lag at the involved digit [6 months post injury]
- Brief Michigan Hand Outcome Questionnaire [12 weeks from injury]
- Brief Michigan Hand Outcome Questionnaire [6 months post injury]
- Satisfaction on a visual analog scale (0-10) [12 weeks from injury]
- Satisfaction on a visual analog scale (0-10) [6 months post injury]
- Goniometric measurement of range of motion deficit for distal interphalangeal joint flexion for involved digit [12 week post injury]
- Goniometric measurement of range of motion deficit for distal interphalangeal joint flexion for involved digit [6 months post injury]
- Pain according to a numeric pain rating scale (0-10/10) [12 weeks after injury]
- Pain according to a numeric pain rating scale (0-10/10) [6 months post injury]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- determined by a physician to require conservative treatment for a mallet finger injury, at least 18 years of age
Exclusion Criteria:
- previous injury to the involved digit impacting ROM
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Orthopaedic Specialty Group PC | Fairfield | Connecticut | United States | 06825 |
Sponsors and Collaborators
- Orthopaedic Specialty Group PC, Fairfield
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Lori Algar,
Hand therapist/occupational therapist,
Orthopaedic Specialty Group PC, Fairfield
ClinicalTrials.gov Identifier:
NCT04830917
Other Study ID Numbers:
- SVMC 17-328
First Posted:
Apr 5, 2021
Last Update Posted:
Apr 21, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: