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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-subluxated - splinting | Active Comparator | Conservative treatment with splinting for 6 weeks. |
|
| Non-subluxated - operation | Active Comparator | Operative treatment with extension block technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conservative treatment with splinting for 6 weeks. | Procedure | Aluminum Karstam splints are used. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | Pain in the affected join. Pain intensity were reported on a numeric rating scale (NRS), from 0-10, with 0 indicating no pain. | 6 month |
| Bump | Number of participants with the presence of a bump on the fracture-site. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bo Munk, MD | Department of Hand Surgery, Aarhus University Hospital, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hand Surgery, Aarhus University Hospital | Aarhus | 8000 | Denmark |
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Patients recruited after referral of mallet fractures from the emergency department Aarhus University Hospital to the department of hand-surgery Aarhus Universityhospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-subluxated - Splinting | Conservative treatment with splinting for 6 weeks. Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used. |
| FG001 | Non-subluxated - Operation | Operative treatment with extension block technique Operative treatment with extension block technique |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-subluxated - Splinting | Conservative treatment with splinting for 6 weeks. Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used. |
| BG001 | Non-subluxated - Operation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | 95% Confidence Interval | degrees extension deficit | 6 month |
|
0-6 months observation after intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-subluxated - Splinting | Conservative treatment with splinting for 6 weeks. Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Secundary subluxation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janni Kjaergaard Thillemann | Aarhus University Hospital | +45 28137303 | teamjanni@gmail.com |
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| ID | Term |
|---|---|
| D000072700 | Conservative Treatment |
| D001864 | Bone Wires |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D016268 | Internal Fixators |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| Operative treatment with extension block technique | Procedure | Surgery with extension block technique. 6 weeks. |
|
|
| 6 month |
| Complications | Number of participants with nail deformities. | 6 month |
| DASH | Questionary: Disabilities of the Arm, Shoulder and Hand Danish version (qDASH). Scale range 0-100, with 0 indicating no disability. | 6 month |
| Flexion of the Distal Interphalangeal Joint. | Flexion of the distal interphalangeal joint. Measured with goniometer. | 6 months |
| Withdrawal by Subject |
|
| Not treated in accordance to guidelines |
|
Operative treatment with extension block technique
Operative treatment with extension block technique: Surgery with extension block technique. 6 weeks.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | units on a scale | 6 month |
|
|
|
| Secondary | Bump | Number of participants with the presence of a bump on the fracture-site. | Posted | Number | participants | 6 month |
|
|
|
| Secondary | Complications | Number of participants with nail deformities. | Posted | Number | participants | 6 month |
|
|
|
| Secondary | DASH | Questionary: Disabilities of the Arm, Shoulder and Hand Danish version (qDASH). Scale range 0-100, with 0 indicating no disability. | Posted | Median | Inter-Quartile Range | units on a scale | 6 month |
|
|
|
| Secondary | Flexion of the Distal Interphalangeal Joint. | Flexion of the distal interphalangeal joint. Measured with goniometer. | Posted | Mean | 95% Confidence Interval | degrees | 6 months |
|
|
|
| 0 |
| 15 |
| 3 |
| 14 |
| EG001 | Non-subluxated - Operation | Operative treatment with extension block technique Operative treatment with extension block technique | 0 | 17 | 0 | 14 |
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| D009984 |
| Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D053831 | Surgical Fixation Devices |