Distal Radius FracturesNCT06631651
The Effect of Intraoperative Brachioradialis Release
A study testing Brachioradialis release and Brachioradialis not released in people with Distal Radius Fractures and Brachioradialis Release, run by Hüseyin Emre Tepedelenlioğlu at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fractures, Brachioradialis Release, Dresdner Scoring
- What is being tested?
- Brachioradialis release and Brachioradialis not released
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jun 2019to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary patients with distal radius fractures requiring operation
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik Şehir Hastanesi
Çankaya, Ankara, 06500
About this study
Official title: 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.
Read the 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.
- Being tested
- Brachioradialis release, Brachioradialis not released
- Keywords
- Distal Radius Fracture, Brachioralis Release, Wrist Function, DASH Score
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brachioradialis releaseProcedure or surgery
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
Brachioradialis not releasedProcedure or surgery
During distal radius fracture surgery (open reduction+internal fixation) brachioradialis release was not performed.
| Study group | Role | What they receive |
|---|---|---|
| Brachioradialis Release Group | Experimental | 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 Receives: Procedure: Brachioradialis release |
| Classic (Non-brachioradialis Release) Group | Sham comparator | During distal radius fracture surgery (open reduction+internal fixation) brachioradialis release was not performed Receives: Procedure: Brachioradialis not released |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation time
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
Measured: 9 months
Anatomical alignment
Dresdner score was calculated by measuring preoperative and postoperative joint grading, radial inclination angle, palmar inclination angle and ulnar variance on radiography.
Measured: 9 months
Strength Tests
Hand, wrist, forearm, and elbow strengths were evaluated with iskoniteic dynamometer
Measured: 9 months
Proprioception measurement
Hand, wrist, forearm, and elbow proprioceptions were evaluated with iskoniteic dynamometer
Measured: 9 months
functional capacity
Jebsen hand function test was performed to evaluate hand function.
Measured: 9 months
Disability level
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.
Measured: 9 months
pinch and grip forces
Key pinch, palmar pinch, tip pinch and gross grip strengths were evaluated with a dynamometer.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start27 Jun 2019
- Primary completion1 Mar 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hüseyin Emre Tepedelenlioğlu
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Hüseyin Emre Tepedelenlioğlu, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631651
- Sponsor's protocol ID
- 91610558-604.01.02-
- Status last verified
- Oct 2024
- First submitted
- 1 Jun 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hagenaars T, Van Oijen GW, Roerdink WH, Vegt PA, Vroemen JP, Verhofstad MH, Van Lieshout EM. Functional recovery after treatment of extra-articular distal radius fractures in the elderly using the IlluminOss(R) System (IO-Wrist); a multicenter prospective observational study. BMC Musculoskelet Disord. 2016 May 27;17:235. doi: 10.1186/s12891-016-1077-9.
PubMed 27233355Walenkamp MM, Vos LM, Strackee SD, Goslings JC, Schep NW. The Unstable Distal Radius Fracture-How Do We Define It? A Systematic Review. J Wrist Surg. 2015 Nov;4(4):307-16. doi: 10.1055/s-0035-1556860.
PubMed 26649263Zhou J, Tang W, Li D, Wu Y. Morphological characteristics of different types of distal radius die-punch fractures based on three-column theory. J Orthop Surg Res. 2019 Nov 27;14(1):390. doi: 10.1186/s13018-019-1453-x.
PubMed 31775810Park MJ, Cooney WP 3rd, Hahn ME, Looi KP, An KN. The effects of dorsally angulated distal radius fractures on carpal kinematics. J Hand Surg Am. 2002 Mar;27(2):223-32. doi: 10.1053/jhsu.2002.32083.
PubMed 11901381Quinn SF, Murray W, Watkins T, Kloss J. CT for determining the results of treatment of fractures of the wrist. AJR Am J Roentgenol. 1987 Jul;149(1):109-11. doi: 10.2214/ajr.149.1.109.
PubMed 3495968Fok MW, Klausmeyer MA, Fernandez DL, Orbay JL, Bergada AL. Volar plate fixation of intra-articular distal radius fractures: a retrospective study. J Wrist Surg. 2013 Aug;2(3):247-54. doi: 10.1055/s-0033-1350086.
PubMed 24436824Kumar S, Khan AN, Sonanis SV. Radiographic and functional evaluation of low profile dorsal versus volar plating for distal radius fractures. J Orthop. 2016 Jul 19;13(4):376-82. doi: 10.1016/j.jor.2016.06.017. eCollection 2016 Dec.
PubMed 27504057Roh YH, Lee BK, Baek JR, Noh JH, Gong HS, Baek GH. A randomized comparison of volar plate and external fixation for intra-articular distal radius fractures. J Hand Surg Am. 2015 Jan;40(1):34-41. doi: 10.1016/j.jhsa.2014.09.025. Epub 2014 Oct 29.
PubMed 25446409Chan YH, Foo TL, Yeo CJ, Chew WY. Comparison between cast immobilization versus volar locking plate fixation of distal radius fractures in active elderly patients, the Asian perspective. Hand Surg. 2014;19(1):19-23. doi: 10.1142/S021881041450004X.
PubMed 24641736Protopsaltis TS, Ruch DS. Volar approach to distal radius fractures. J Hand Surg Am. 2008 Jul-Aug;33(6):958-65. doi: 10.1016/j.jhsa.2008.04.018.
PubMed 18656773Koh S, Andersen CR, Buford WL Jr, Patterson RM, Viegas SF. Anatomy of the distal brachioradialis and its potential relationship to distal radius fracture. J Hand Surg Am. 2006 Jan;31(1):2-8. doi: 10.1016/j.jhsa.2005.08.012.
PubMed 16443096Sarmiento A. The brachioradialis as a deforming force in Colles' fractures. Clin Orthop Relat Res. 1965 Jan-Feb;38:86-92. No abstract available.
PubMed 5889097Orbay JL, Fernandez DL. Volar fixation for dorsally displaced fractures of the distal radius: a preliminary report. J Hand Surg Am. 2002 Mar;27(2):205-15. doi: 10.1053/jhsu.2002.32081.
PubMed 11901379Orbay JL, Badia A, Indriago IR, Infante A, Khouri RK, Gonzalez E, Fernandez DL. The extended flexor carpi radialis approach: a new perspective for the distal radius fracture. Tech Hand Up Extrem Surg. 2001 Dec;5(4):204-11. doi: 10.1097/00130911-200112000-00004. No abstract available.
PubMed 16520583Wijffels MM, Orbay JL, Indriago I, Ring D. The extended flexor carpi radialis approach for partially healed malaligned fractures of the distal radius. Injury. 2012 Jul;43(7):1204-8. doi: 10.1016/j.injury.2012.04.002. Epub 2012 Apr 27.
PubMed 22542167
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Brachioradialis Release on Radiological and Functional Outcomes in Distal Radius Fractures: Long-Term Results
- ClinicalTrials.gov ID
- NCT06631651
- Acronym / sponsor ID
- 91610558-604.01.02-
- Keywords
- Distal Radius Fracture, Brachioralis Release, Wrist Function, DASH Score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Hüseyin Emre TepedelenlioğluOther government
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Brachioradialis Release Group | Experimental | Procedure: Brachioradialis releaseDuring 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 |
| Classic (Non-brachioradialis Release) Group | Sham comparator | Procedure: Brachioradialis not releasedDuring distal radius fracture surgery (open reduction+internal fixation) brachioradialis release was not performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Voluntary patients with distal radius fractures requiring operation
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brachioradialis releaseDuring 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 or surgery | Brachioradialis Release Group |
| Brachioradialis not releasedDuring distal radius fracture surgery (open reduction+internal fixation) brachioradialis release was not performed. | Procedure or surgery | Classic (Non-brachioradialis Release) Group |
Primary outcome
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
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.
Strength Tests
Time frame: 9 months
Hand, wrist, forearm, and elbow strengths were evaluated with iskoniteic dynamometer
Proprioception measurement
Time frame: 9 months
Hand, wrist, forearm, and elbow proprioceptions were evaluated with iskoniteic dynamometer
functional capacity
Time frame: 9 months
Jebsen hand function test was performed to evaluate hand function.
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.
pinch and grip forces
Time frame: 9 months
Key pinch, palmar pinch, tip pinch and gross grip strengths were evaluated with a dynamometer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Results publication: PubMed 27233355Hagenaars T, Van Oijen GW, Roerdink WH, Vegt PA, Vroemen JP, Verhofstad MH, Van Lieshout EM. Functional recovery after treatment of extra-articular distal radius fractures in the elderly using the IlluminOss(R) System (IO-Wrist); a multicenter prospective observational study. BMC Musculoskelet Disord. 2016 May 27;17:235. doi: 10.1186/s12891-016-1077-9.
- Results publication: PubMed 26649263Walenkamp MM, Vos LM, Strackee SD, Goslings JC, Schep NW. The Unstable Distal Radius Fracture-How Do We Define It? A Systematic Review. J Wrist Surg. 2015 Nov;4(4):307-16. doi: 10.1055/s-0035-1556860.
- Results publication: PubMed 31775810Zhou J, Tang W, Li D, Wu Y. Morphological characteristics of different types of distal radius die-punch fractures based on three-column theory. J Orthop Surg Res. 2019 Nov 27;14(1):390. doi: 10.1186/s13018-019-1453-x.
- Results publication: PubMed 11901381Park MJ, Cooney WP 3rd, Hahn ME, Looi KP, An KN. The effects of dorsally angulated distal radius fractures on carpal kinematics. J Hand Surg Am. 2002 Mar;27(2):223-32. doi: 10.1053/jhsu.2002.32083.
- Results publication: PubMed 3495968Quinn SF, Murray W, Watkins T, Kloss J. CT for determining the results of treatment of fractures of the wrist. AJR Am J Roentgenol. 1987 Jul;149(1):109-11. doi: 10.2214/ajr.149.1.109.
- Results publication: PubMed 24436824Fok MW, Klausmeyer MA, Fernandez DL, Orbay JL, Bergada AL. Volar plate fixation of intra-articular distal radius fractures: a retrospective study. J Wrist Surg. 2013 Aug;2(3):247-54. doi: 10.1055/s-0033-1350086.
- Results publication: PubMed 27504057Kumar S, Khan AN, Sonanis SV. Radiographic and functional evaluation of low profile dorsal versus volar plating for distal radius fractures. J Orthop. 2016 Jul 19;13(4):376-82. doi: 10.1016/j.jor.2016.06.017. eCollection 2016 Dec.
- Results publication: PubMed 25446409Roh YH, Lee BK, Baek JR, Noh JH, Gong HS, Baek GH. A randomized comparison of volar plate and external fixation for intra-articular distal radius fractures. J Hand Surg Am. 2015 Jan;40(1):34-41. doi: 10.1016/j.jhsa.2014.09.025. Epub 2014 Oct 29.
- Results publication: PubMed 24641736Chan YH, Foo TL, Yeo CJ, Chew WY. Comparison between cast immobilization versus volar locking plate fixation of distal radius fractures in active elderly patients, the Asian perspective. Hand Surg. 2014;19(1):19-23. doi: 10.1142/S021881041450004X.
- Results publication: PubMed 18656773Protopsaltis TS, Ruch DS. Volar approach to distal radius fractures. J Hand Surg Am. 2008 Jul-Aug;33(6):958-65. doi: 10.1016/j.jhsa.2008.04.018.
- Results publication: PubMed 16443096Koh S, Andersen CR, Buford WL Jr, Patterson RM, Viegas SF. Anatomy of the distal brachioradialis and its potential relationship to distal radius fracture. J Hand Surg Am. 2006 Jan;31(1):2-8. doi: 10.1016/j.jhsa.2005.08.012.
- Results publication: PubMed 5889097Sarmiento A. The brachioradialis as a deforming force in Colles' fractures. Clin Orthop Relat Res. 1965 Jan-Feb;38:86-92. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brachioradialis release and Brachioradialis not released in people with Distal Radius Fractures and Brachioradialis Release, run by Hüseyin Emre Tepedelenlioğlu at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operation time (time frame: 9 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06631651, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.