Trial Outcomes & Findings for Extension Block Technique Versus Splinting in Mallet Finger Fracture. (NCT NCT01738919)

NCT ID: NCT01738919

Last Updated: 2016-11-04

Results Overview

Extension deficit measured in degrees, using goniometer. (The lacking extension from at straight stretched finger = degrees of extension deficit)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 32 participants
• Primary outcome timeframe: 6 month
• Results posted on: 2016-11-04

Participant Flow

Patients recruited after referral of mallet fractures from the emergency department Aarhus University Hospital to the department of hand-surgery Aarhus Universityhospital.

Participant milestones

Measure	Non-subluxated - Splinting Conservative treatment with splinting for 6 weeks. Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.	Non-subluxated - Operation Operative treatment with extension block technique Operative treatment with extension block technique
Overall Study STARTED	15	17
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	Non-subluxated - Splinting Conservative treatment with splinting for 6 weeks. Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.	Non-subluxated - Operation Operative treatment with extension block technique Operative treatment with extension block technique
Overall Study Lost to Follow-up	1	0
Overall Study Immigrated	0	1
Overall Study Withdrawal by Subject	0	1
Overall Study Not treated in accordance to guidelines	0	1

Baseline Characteristics

Extension Block Technique Versus Splinting in Mallet Finger Fracture.

Baseline characteristics by cohort

Measure	Non-subluxated - Splinting n=15 Participants Conservative treatment with splinting for 6 weeks. Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.	Non-subluxated - Operation n=17 Participants Operative treatment with extension block technique Operative treatment with extension block technique: Surgery with extension block technique. 6 weeks.	Total n=32 Participants Total of all reporting groups
Age, Continuous	30 years n=5 Participants	42 years n=7 Participants	31 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment Denmark	15 participants n=5 Participants	17 participants n=7 Participants	32 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 month

Extension deficit measured in degrees, using goniometer. (The lacking extension from at straight stretched finger = degrees of extension deficit)

Outcome measures

Measure	Non-subluxated - Splinting n=14 Participants Conservative treatment with splinting for 6 weeks. Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.	Non-subluxated - Operation n=14 Participants Operative treatment with extension block technique Operative treatment with extension block technique: Surgery with extension block technique. 6 weeks.
Extension Deficit in the Affected Distal Interphalangeal Joint.	12 degrees extension deficit Interval 8.0 to 16.0	10 degrees extension deficit Interval 4.0 to 16.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Non-subluxated - Splinting n=14 Participants Conservative treatment with splinting for 6 weeks. Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.	Non-subluxated - Operation n=14 Participants Operative treatment with extension block technique Operative treatment with extension block technique: Surgery with extension block technique. 6 weeks.
Pain	1 units on a scale Interval 0.0 to 1.0	1.5 units on a scale Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: 6 month

Number of participants with the presence of a bump on the fracture-site.

Outcome measures

Measure	Non-subluxated - Splinting n=14 Participants Conservative treatment with splinting for 6 weeks. Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.	Non-subluxated - Operation n=14 Participants Operative treatment with extension block technique Operative treatment with extension block technique: Surgery with extension block technique. 6 weeks.
Bump	7 participants	5 participants

SECONDARY outcome

Timeframe: 6 month

Number of participants with nail deformities.

Outcome measures

Measure	Non-subluxated - Splinting n=14 Participants Conservative treatment with splinting for 6 weeks. Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.	Non-subluxated - Operation n=14 Participants Operative treatment with extension block technique Operative treatment with extension block technique: Surgery with extension block technique. 6 weeks.
Complications	2 participants	4 participants

SECONDARY outcome

Timeframe: 6 month

Questionary: Disabilities of the Arm, Shoulder and Hand Danish version (qDASH). Scale range 0-100, with 0 indicating no disability.

Outcome measures

Measure	Non-subluxated - Splinting n=14 Participants Conservative treatment with splinting for 6 weeks. Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.	Non-subluxated - Operation n=14 Participants Operative treatment with extension block technique Operative treatment with extension block technique: Surgery with extension block technique. 6 weeks.
DASH	4.5 units on a scale Interval 0.0 to 9.0	12.6 units on a scale Interval 0.0 to 20.5

SECONDARY outcome

Timeframe: 6 months

Flexion of the distal interphalangeal joint. Measured with goniometer.

Outcome measures

Measure	Non-subluxated - Splinting n=14 Participants Conservative treatment with splinting for 6 weeks. Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.	Non-subluxated - Operation n=14 Participants Operative treatment with extension block technique Operative treatment with extension block technique: Surgery with extension block technique. 6 weeks.
Flexion of the Distal Interphalangeal Joint.	65 degrees Interval 59.0 to 71.0	50 degrees Interval 39.0 to 61.0

Adverse Events

Non-subluxated - Splinting

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Non-subluxated - Operation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Non-subluxated - Splinting n=14 participants at risk；n=15 participants at risk Conservative treatment with splinting for 6 weeks. Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.	Non-subluxated - Operation n=14 participants at risk；n=17 participants at risk Operative treatment with extension block technique Operative treatment with extension block technique
Musculoskeletal and connective tissue disorders Secundary subluxation	21.4% 3/14 • 0-6 months observation after intervention	0.00% 0/14 • 0-6 months observation after intervention

Additional Information

Janni Kjaergaard Thillemann

Aarhus University Hospital

Phone: +45 28137303

Email: teamjanni@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place