The Effect of Intraoperative Brachioradialis Release

October 6, 2024 updated by: Hüseyin Emre Tepedelenlioğlu

The Effect of Intraoperative Brachioradialis Release on Radiological and Functional Outcomes in Distal Radius Fractures: Long-Term Results

Distal radius fractures are increasingly common, necessitating surgical intervention in many cases for optimal outcomes. Volar plate fixation has emerged as a preferred surgical method due to its effectiveness in promoting faster healing. However, challenges persist in achieving anatomical reduction, particularly concerning the styloid process, where the brachioradialis muscle insertion complicates the procedure. This study explores the impact of intraoperative brachioradialis release on wrist and elbow functions in distal radius fractures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This two-stage study was conducted in 124 patients who underwent surgery for distal radius fracture between 2011 and 2019. In the first phase, the anatomical alignment of the distal radius was analysed retrospectively. In the second phase, functional assessments of the patients' upper extremities were performed. Patients who underwent open reduction and internal fixation (ARIF) for distal radius end fractures and who agreed to participate in the study were included. Patients who were treated with a method other than ARIF, who had bilateral injuries (valid only for the second phase), who had a fracture in a bone other than the radius, and who had any other neurological or orthopaedic disorder that would affect the assessment were not included in the study.

For the first phase, 124 patients were divided into 2 groups: patients with brachioradialis release (76 patients) and patients without brachioradialis release (38 patients). The release of the brachioradialis muscle was achieved through partial release from its insertion into the styloid process, rather than through Z-plasty. In both groups, the pre- and post-operative radiographs of the operated patients were analysed and the operative times of the operations were recorded. The Dresdner score was calculated by measuring the preoperative and postoperative joint grading, radial tilt angle, palmar tilt angle and ulnar variance on the radiographs. A lower Dresdner score indicated better anatomical alignment.

For the second phase, 124 patients were contacted by telephone. Sixty-one patients who could not be reached or did not meet the inclusion criteria were excluded from the study. The remaining 63 patients were divided into two groups: brachioradialis release and non-brachioradialis release.

In the second stage, hand, wrist and elbow strength, proprioceptive function and disability level of the patients were assessed as functional assessments. The Jebsen Hand Function Test (JEFT) was used to assess hand function.

Wrist flexion-extension, elbow flexion-extension and forearm supination-pronation forces were assessed using an isokinetic dynamometer (Cybex NORM®; Humac, CA, Computer Sports Medicine, Inc., Stoughton, MA).

Elbow flexion-extension strength measurements were conducted while the patient was lying supine on the platform of the isokinetic dynamometer.

Forearm supination-pronation force measurement was performed using an isokinetic dynamometer.

Functional forces of the hand, including key pinch, palmar pinch, tip pinch, and gross grip forces, were evaluated.

Wrist proprioception was assessed by measuring active joint position sense (AJPS).

To evaluate the participants' disability during daily activities, the Turkish version of the Disability Assessment of Arm, Shoulder and Hand Injury Questionnaire (DASH-T) was used.

Statistical Analysis

SPSS 22.0 statistical package was used for the statistical analysis of the data. The normal distribution of the data was assessed using histogram plots, normal Q-Q plots with correction, coefficients of skewness and kurtosis, coefficient of variance and the Shapiro-Wilk test. In the descriptive section of the statistical analysis of the data, categorical variables were presented with numbers, continuous variables with mean and standard deviation for normally distributed variables, and median (minimum-maximum) for non-normally distributed variables. For comparisons between groups, parametric and non-parametric data, the independent samples t-test and the Mann-Whitney U test were used. Changes in parametric variables with repeated measurements were compared between groups using an ordered samples t-test. In this study, the statistical significance level was accepted as p<0.05 with 95% confidence interval. The effect size was expressed as the (eta2) value.

Study Type

Interventional

Enrollment (Actual)

124

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Turkey
- Ankara
  - Çankaya, Ankara, Turkey, 06500
    - Ankara Etlik Sehir Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Voluntary patients with distal radius fractures requiring operation

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brachioradialis Release Group During distal radius fracture surgery (open reduction+internal fixation) partial brachioradialis release from the insertion of brachioradialis muscle was performed in order to perform reduction of fracture	Procedure: Brachioradialis release During distal radius fracture surgery (open reduction+internal fixation) partial brachioradialis release from the insertion of brachioradialis muscle was performed in order to perform reduction of fracture
Sham Comparator: Classic (Non-brachioradialis Release) Group During distal radius fracture surgery (open reduction+internal fixation) brachioradialis release was not performed	Procedure: Brachioradialis not released During distal radius fracture surgery (open reduction+internal fixation) brachioradialis release was not performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation time Time Frame: 9 months	To compare the time taken by the surgical methods, the operation times were compared. For this, the start and end times of the operation were analyzed	9 months
Anatomical alignment Time Frame: 9 months	Dresdner score was calculated by measuring preoperative and postoperative joint grading, radial inclination angle, palmar inclination angle and ulnar variance on radiography.	9 months
Strength Tests Time Frame: 9 months	Hand, wrist, forearm, and elbow strengths were evaluated with iskoniteic dynamometer	9 months
Proprioception measurement Time Frame: 9 months	Hand, wrist, forearm, and elbow proprioceptions were evaluated with iskoniteic dynamometer	9 months
functional capacity Time Frame: 9 months	Jebsen hand function test was performed to evaluate hand function.	9 months
Disability level Time Frame: 9 months	The Turkish version of the Disability Assessment of Arm, Shoulder and Hand Injury Questionnaire (DASH-T) was used to assess the participants' disability during activities of daily living.	9 months
pinch and grip forces Time Frame: 9 months	Key pinch, palmar pinch, tip pinch and gross grip strengths were evaluated with a dynamometer.	9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hüseyin Emre Tepedelenlioğlu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2019

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

June 1, 2024

First Submitted That Met QC Criteria

October 6, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 6, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

91610558-604.01.02-

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

The Effect of Intraoperative Brachioradialis Release