CClinicalTrials.gg
CompletedNCT06631651Updated Oct 8, 2024

The Effect of Intraoperative Brachioradialis Release

An interventional study of Brachioradialis release and Brachioradialis not released in Distal Radius Fractures, Brachioradialis Release and Dresdner Scoring, sponsored by Hüseyin Emre Tepedelenlioğlu. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-08.

Sponsored by Hüseyin Emre Tepedelenlioğlu · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 11 months after the study started (first participant enrolled Jun 2019, registered Jun 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Distal Radius Fractures
  • Brachioradialis Release
  • Dresdner Scoring

Keywords

  • Distal Radius Fracture
  • Brachioralis Release
  • Wrist Function
  • DASH Score
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's enrollment of 124 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

This is the only study on the registry with Hüseyin Emre Tepedelenlioğlu as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Voluntary patients with distal radius fractures requiring operation

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
124 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • ProcedureBrachioradialis 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

  • ProcedureBrachioradialis not released

    During distal radius fracture surgery (open reduction+internal fixation) brachioradialis release was not performed.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 9 months

  2. Anatomical alignment

    Dresdner score was calculated by measuring preoperative and postoperative joint grading, radial inclination angle, palmar inclination angle and ulnar variance on radiography.

    Time frame: 9 months

  3. Strength Tests

    Hand, wrist, forearm, and elbow strengths were evaluated with iskoniteic dynamometer

    Time frame: 9 months

  4. Proprioception measurement

    Hand, wrist, forearm, and elbow proprioceptions were evaluated with iskoniteic dynamometer

    Time frame: 9 months

  5. functional capacity

    Jebsen hand function test was performed to evaluate hand function.

    Time frame: 9 months

  6. 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.

    Time frame: 9 months

  7. pinch and grip forces

    Key pinch, palmar pinch, tip pinch and gross grip strengths were evaluated with a dynamometer.

    Time frame: 9 months

07

Study locations

1 site
  • Ankara Etlik Şehir Hastanesi
    Çankaya, Ankara 06500, Turkey
08

References and documents

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 27233355 ↗
  • Walenkamp 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 26649263 ↗
  • Zhou 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 31775810 ↗
  • Park 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 11901381 ↗
  • Quinn 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 3495968 ↗
  • Fok 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 24436824 ↗
  • Kumar 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 27504057 ↗
  • Roh 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 25446409 ↗
  • Chan 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 24641736 ↗
  • Protopsaltis 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 18656773 ↗
  • Koh 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 16443096 ↗
  • Sarmiento A. The brachioradialis as a deforming force in Colles' fractures. Clin Orthop Relat Res. 1965 Jan-Feb;38:86-92. No abstract available. PubMed 5889097 ↗
  • Orbay 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 11901379 ↗
  • Orbay 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 16520583 ↗
  • Wijffels 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 ↗
  • Murray WM, Delp SL, Buchanan TS. Variation of muscle moment arms with elbow and forearm position. J Biomech. 1995 May;28(5):513-25. doi: 10.1016/0021-9290(94)00114-j. PubMed 7775488 ↗
  • Kim JK, Park JS, Shin SJ, Bae H, Kim SY. The effect of brachioradialis release during distal radius fracture fixation on elbow flexion strength and wrist function. J Hand Surg Am. 2014 Nov;39(11):2246-50. doi: 10.1016/j.jhsa.2014.07.043. Epub 2014 Sep 11. PubMed 25218141 ↗
  • Lalone E, MacDermid J, Grewal R, King G. Patient Reported Pain and Disability Following a Distal Radius Fracture: A Prospective Study. Open Orthop J. 2017 Jul 31;11:589-599. doi: 10.2174/1874325001711010589. eCollection 2017. PubMed 28979578 ↗
  • Schneiders W, Biewener A, Rammelt S, Rein S, Zwipp H, Amlang M. [Distal radius fracture. Correlation between radiological and functional results]. Unfallchirurg. 2006 Oct;109(10):837-44. doi: 10.1007/s00113-006-1156-8. German. PubMed 16969651 ↗
  • Jebsen RH, Taylor N, Trieschmann RB, Trotter MJ, Howard LA. An objective and standardized test of hand function. Arch Phys Med Rehabil. 1969 Jun;50(6):311-9. No abstract available. PubMed 5788487 ↗
  • Oliveira LC, Pires-Oliveira DA, Abucarub AC, Oliveira LS, Oliveira RG. Pilates increases isokinetic muscular strength of the elbow flexor and extensor muscles of older women: A randomized controlled clinical trial. J Bodyw Mov Ther. 2017 Jan;21(1):2-10. doi: 10.1016/j.jbmt.2016.03.002. Epub 2016 Mar 10. PubMed 28167180 ↗
  • Ellenbecker TS, Roetert EP, Riewald S. Isokinetic profile of wrist and forearm strength in elite female junior tennis players. Br J Sports Med. 2006 May;40(5):411-4. doi: 10.1136/bjsm.2005.023358. PubMed 16632571 ↗
  • Seven B, Cobanoglu G, Oskay D, Atalay-Guzel N. Test-Retest Reliability of Isokinetic Wrist Strength and Proprioception Measurements. J Sport Rehabil. 2019 Sep 1;28(7):jsr.2018-0341. doi: 10.1123/jsr.2018-0341. PubMed 30676238 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06631651
Lead sponsor
Hüseyin Emre Tepedelenlioğlu
Responsible party
Hüseyin Emre Tepedelenlioğlu (M.D., Ph.D., Ankara Etlik City Hospital) — Sponsor-investigator
First posted
Oct 8, 2024
Start date
Jun 27, 2019
Primary completion
Mar 1, 2020
Completion
Apr 1, 2020
Last update
Oct 8, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion