Mallet Finger
Conditions
Brief summary
Mallet finger is an avulsion of the extensor tendon at its insertion on the base of the distal phalanx, with or without fracture. Treatment af mallet finger fractures involving more than 1/3 of the articulating surface is controversial. There are to our knowledge no randomized controlled trials comparing splinting and surgical treatment with extension block technique. The aim of this study is to compare splinting and surgical extension block fixation of mallet finger fractures in a randomized controlled trial.Our hypothesis is that conservative treatment with splinting is comparable to surgical treatment concerning functional outcome, and may even reduce the complication rates. The original protocol was designed to include participants with non-subluxated and subluxated mallet finger fractures. However this study only included participants with non-subluxated fingers.
Interventions
PROCEDUREConservative treatment with splinting for 6 weeks.
Aluminum Karstam splints are used.
PROCEDUREOperative treatment with extension block technique
Surgery with extension block technique. 6 weeks.
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years * Mallet finger fractures with a \>1mm displaced fragment involving one-third or more of the articular surface and/ or subluxation of the distal phalanges. * Fractures with a delay of \< 2 weeks. * With reference to Wehbé and Schneider's established classification, fractures type IB and IC are included.
Exclusion criteria
* Open injuries * Mallet finger fracture of the thumb * Co-existing rheumatologic illness in the fingers * No-compliance patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extension Deficit in the Affected Distal Interphalangeal Joint. | 6 month | Extension deficit measured in degrees, using goniometer. (The lacking extension from at straight stretched finger = degrees of extension deficit) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain | 6 month | Pain in the affected join. Pain intensity were reported on a numeric rating scale (NRS), from 0-10, with 0 indicating no pain. |
| Bump | 6 month | Number of participants with the presence of a bump on the fracture-site. |
| Complications | 6 month | Number of participants with nail deformities. |
| DASH | 6 month | Questionary: Disabilities of the Arm, Shoulder and Hand Danish version (qDASH). Scale range 0-100, with 0 indicating no disability. |
| Flexion of the Distal Interphalangeal Joint. | 6 months | Flexion of the distal interphalangeal joint. Measured with goniometer. |
Countries
Denmark
Participant flow
Recruitment details
Patients recruited after referral of mallet fractures from the emergency department Aarhus University Hospital to the department of hand-surgery Aarhus Universityhospital.
Participants by arm
| Arm | Count |
|---|---|
| Non-subluxated - Splinting Conservative treatment with splinting for 6 weeks.
Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used. | 15 |
| Non-subluxated - Operation Operative treatment with extension block technique
Operative treatment with extension block technique: Surgery with extension block technique. 6 weeks. | 17 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Immigrated | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Not treated in accordance to guidelines | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Non-subluxated - Splinting | Non-subluxated - Operation | Total |
|---|---|---|---|
| Age, Continuous | 30 years | 42 years | 31 years |
| Region of Enrollment Denmark | 15 participants | 17 participants | 32 participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 14 Participants |
| Sex: Female, Male Male | 10 Participants | 8 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 15 | 0 / 17 |
Outcome results
Primary
Extension Deficit in the Affected Distal Interphalangeal Joint.
Extension deficit measured in degrees, using goniometer. (The lacking extension from at straight stretched finger = degrees of extension deficit)
Time frame: 6 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-subluxated - Splinting | Extension Deficit in the Affected Distal Interphalangeal Joint. | 12 degrees extension deficit |
| Non-subluxated - Operation | Extension Deficit in the Affected Distal Interphalangeal Joint. | 10 degrees extension deficit |
Secondary
Bump
Number of participants with the presence of a bump on the fracture-site.
Time frame: 6 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-subluxated - Splinting | Bump | 7 participants |
| Non-subluxated - Operation | Bump | 5 participants |
Secondary
Complications
Number of participants with nail deformities.
Time frame: 6 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-subluxated - Splinting | Complications | 2 participants |
| Non-subluxated - Operation | Complications | 4 participants |
Secondary
DASH
Questionary: Disabilities of the Arm, Shoulder and Hand Danish version (qDASH). Scale range 0-100, with 0 indicating no disability.
Time frame: 6 month
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Non-subluxated - Splinting | DASH | 4.5 units on a scale |
| Non-subluxated - Operation | DASH | 12.6 units on a scale |
Secondary
Flexion of the Distal Interphalangeal Joint.
Flexion of the distal interphalangeal joint. Measured with goniometer.
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-subluxated - Splinting | Flexion of the Distal Interphalangeal Joint. | 65 degrees |
| Non-subluxated - Operation | Flexion of the Distal Interphalangeal Joint. | 50 degrees |
Secondary
Pain
Pain in the affected join. Pain intensity were reported on a numeric rating scale (NRS), from 0-10, with 0 indicating no pain.
Time frame: 6 month
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Non-subluxated - Splinting | Pain | 1 units on a scale |
| Non-subluxated - Operation | Pain | 1.5 units on a scale |