Clinical trial NCT06631651: The Effect of Intraoperative Brachioradialis Release
Official title: The Effect of Intraoperative Brachioradialis Release on Radiological and Functional Outcomes in Distal Radius Fractures: Long-Term Results
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fractures
Brachioradialis Release
Dresdner Scoring
Keywords: Distal Radius Fracture
Brachioralis Release
Wrist Function
DASH Score
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-08
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A retrospective analysis was conducted on 124 patients undergoing surgery for distal radius fractures. Patients were divided into groups based on whether they underwent brachioradialis release during surgery. Pre- and post-operative radiographs were analyzed for anatomical alignment using the Dresdner score. Functional assessments included hand, wrist, and elbow strength, proprioceptive function, and disability levels.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

Voluntary patients with distal radius fractures requiring operation

Exclusion Criteria:

-

Primary outcomes:
measure: Operation time
timeFrame: 9 months
measure: Anatomical alignment
timeFrame: 9 months
measure: Strength Tests
timeFrame: 9 months
measure: Proprioception measurement
timeFrame: 9 months
measure: functional capacity
timeFrame: 9 months
measure: Disability level
timeFrame: 9 months
measure: pinch and grip forces
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Çankaya
country: Turkey
facility: Ankara Etlik Şehir Hastanesi
state: Ankara
Study officials:
References:
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