Treatment of Bennett fractures with tension-band wiring through a small incision under loupes and headlight

ISRCTN	ISRCTN64894535
DOI	https://doi.org/10.1186/ISRCTN64894535
Protocol serial number	THHMC20184561
Sponsor	Third Hospital of Hebei Medical University
Funder	Third Hospital of Hebei Medical University

Submission date: 09/09/2018
Registration date: 19/09/2018
Last edited: 06/12/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
A Bennett fracture is a common fracture of the thumb. Although numerous treatments have been proposed, the best treatment choice is still controversial. The aim of this study is to investigate the effectiveness of treating Bennett fractures with tension-band wiring through a small incision (cut) under loupes (magnifying lenses) and headlight.

Who can participate?
Patients with Bennett fractures

What does the study involve?
All participants receive treatment with tension-band wiring through a small incision under loupes and headlight. At the final follow-up at 20 months after surgery, joint range of motion, pinch and grip strength, and hand function are assessed.

What are the possible benefits and risks of participating?
Possible benefits include early range of motion which results in a better function of the thumb. Possible risks include joint stiffness and wound infection.

Where is the study run from?
Third Hospital of Hebei Medical University (China)

When is the study starting and how long is it expected to run for?
August 2014 to October 2017

Who is funding the study?
Third Hospital of Hebei Medical University (China)

Who is the main contact?
Dr Xu Zhang
ahand@sina.com

Contact information

Dr Xu Zhang
Public

Department of Hand Surgery
Third Hospital of Hebei Medical University
Shijiazhuang
050051
China

ORCID ID	0000-0002-3383-2781
Phone	+6-13933512651
Email	ahand@sina.com

Study information

Primary study design	Observational
Study design	Observational case series
Secondary study design	Case series
Scientific title	Treatment of Bennett fractures with tension-band wiring through a small incision under loupes and headlight
Study acronym	TBW
Study objectives	Treatment of Bennett fractures with tension-band wiring through a small incision under loupes and headlight. The treatments are effective with the use of the technique.
Ethics approval(s)	Institutional review board of the Third Hospital of Hebei Medical University, 18/09/2014, ref: THHMC20141547
Health condition(s) or problem(s) studied	Bennett fractures
Intervention	Treatment of Bennett fractures with tension-band wiring through a small incision under loupes and headlight. The tension band wiring technique was performed in 37 Bennett fractures. The mean time between the injury and operation was 6 days. At the final follow-up, range of motion, pinch and grip strength, and function were assessed.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Range of motion: active motion of the first CMC joint assessed using a goniometer at 20 months after surgery
Key secondary outcome measure(s)	Measured at 20 months after surgery: 1. Pinch and grip strengths measured using dynamometers. In order to exclude the discrepancy between the dominant and nondominant hand strength, the scores for analysis were based on that the pinch strength was 5% and grip strength was 6% higher at dominant sides compared to the nondominant sides. 2. Hand function assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Completion date	01/10/2017

Eligibility

Participant type(s)	All
Age group	Adult
Sex	All
Target sample size at registration	37
Key inclusion criteria	1. A Bennett fracture with intra-articular gap or step-off at or above 1 mm 2. Size of the fragment at or above 20% of the joint surface on the lateral view 3. Normal opposite hand for comparison
Key exclusion criteria	Rolando fracture, comminuted fracture, and other combined injuries of the same hand
Date of first enrolment	01/10/2014
Date of final enrolment	21/11/2015

Locations

Countries of recruitment

China

Study participating centre

Third Hospital of Hebei Medical University

Ziqiang road
Shijiazhuang
050051
China

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/02/2019		Yes	No

Editorial Notes

06/12/2021: Corrected publication type from protocol to results.
15/10/2018: Publication reference added