Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631651
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-06-01
Brief Title:
The Effect of Intraoperative Brachioradialis Release
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Intraoperative Brachioradialis Release on Radiological and Functional Outcomes in Distal Radius Fractures Long-Term Results
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 220 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 p005 with 95 confidence interval The effect size was expressed as the eta2 value
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 220 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 p005 with 95 confidence interval The effect size was expressed as the eta2 value
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None