Condition category
Injury, Occupational Diseases, Poisoning
Date applied
09/09/2018
Date assigned
19/09/2018
Last edited
15/10/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Dr Xu Zhang

ORCID ID

http://orcid.org/0000-0002-3383-2781

Contact details

Department of Hand Surgery
Third Hospital of Hebei Medical University
Shijiazhuang
050051
China
+6-13933512651
ahand@sina.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

THHMC20184561

Study information

Scientific title

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

Acronym

TBW

Study hypothesis

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

Institutional review board of the Third Hospital of Hebei Medical University, 18/09/2014, ref: THHMC20141547

Study design

Observational case series

Primary study design

Observational

Secondary study design

Case series

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Drug names

Primary outcome measure

Range of motion: active motion of the first CMC joint assessed using a goniometer at 20 months after surgery

Secondary outcome measures

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

Overall trial start date

15/08/2014

Overall trial end date

01/10/2017

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

All

Age group

Adult

Gender

Both

Target number of participants

37

Participant exclusion criteria

Rolando fracture, comminuted fracture, and other combined injuries of the same hand

Recruitment start date

01/10/2014

Recruitment end date

21/11/2015

Locations

Countries of recruitment

China

Trial participating centre

Third Hospital of Hebei Medical University
Ziqiang road
Shijiazhuang
050051
China

Sponsor information

Organisation

Third Hospital of Hebei Medical University

Sponsor details

Department of Hand Surgery
Shijiazhuang
050051
China

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

Third Hospital of Hebei Medical University

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in the Physician and Sportsmedicine journal.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/12/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

1. 2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30312111

Publication citations

Additional files

Editorial Notes

15/10/2018: Publication reference added