Arthroscopic Assisted CC Stabilization Alone VS Additional K-wire Fixation for Acute Acromioclavicular Joint Injury
NCT ID: NCT05844098
Last Updated: 2024-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-04-01
2024-12-30
Brief Summary
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The main question it aims to answer is:
\- Does Arthroscopic assisted CC-stabilization with additional K-wire fixation provide different outcomes in functional outcomes, CC-distance and GACA difference compare with arthroscopic assisted CC-stabilization alone in acute acromioclavicular joint injury?
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Detailed Description
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This RCT study is designed for comparing functional outcomes (ACJI score, VAS, Constant score and DASH score) and radioligic outcomes (CC-distance difference, GACA difference) between intervention group (Arthroscopic assisted CC-stabilzation with additional K-wire fixation) and control group (Arthroscopic assisted CC-stabilzation alone) for acute ACJI.
The main question it aims to answer is:
\- Does Arthroscopic assisted CC-stabilization with additional K-wire fixation provide different outcomes in functional outcomes, CC-distance and GACA difference compare with arthroscopic assisted CC-stabilization alone in acute acromioclavicular joint injury?
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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With K-wire
arthroscopic assisted CC-stabilization with K-wire
K-wire
K-wire No. 2.0 insertion was done additionally from arthroscopic assisted CC-stabilization by inserting K-wire from acromion process to distal clavicle.
No K-wire
arthroscopic assisted CC-stabilization
No interventions assigned to this group
Interventions
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K-wire
K-wire No. 2.0 insertion was done additionally from arthroscopic assisted CC-stabilization by inserting K-wire from acromion process to distal clavicle.
Eligibility Criteria
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Inclusion Criteria
* Acute AC joint injury rockwood classification III, IV and V
Exclusion Criteria
* Specific active associated ipsilateral injury (Rib fractures, clavicel fractures, scapula fractures and base of coracoid fractures)
* Onset of injury more than 3 weeks
* Cannot underwent arthroscopic assisted CC-stabilization surgery
18 Years
45 Years
ALL
No
Sponsors
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Queen Savang Vadhana Memorial Hospital, Thailand
OTHER
Responsible Party
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Principal Investigators
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Nachapong Sithiwichankit, MD
Role: PRINCIPAL_INVESTIGATOR
QSMVH
Locations
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Queen Savang Vadhana Memorial Hospital
Chon Buri, , Thailand
Countries
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Central Contacts
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Surasak Srimongkolpitak, M.D
Role: CONTACT
Facility Contacts
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Surasak Srimongkolpitak, M.D.
Role: backup
References
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Frank RM, Cotter EJ, Leroux TS, Romeo AA. Acromioclavicular Joint Injuries: Evidence-based Treatment. J Am Acad Orthop Surg. 2019 Sep 1;27(17):e775-e788. doi: 10.5435/JAAOS-D-17-00105.
Goldenberg MM. Analysis of the inhibitory innervation of the isolated gerbil colon. Arch Int Pharmacodyn Ther. 1968 Oct;175(2):347-64. No abstract available.
Beitzel K, Mazzocca AD, Bak K, Itoi E, Kibler WB, Mirzayan R, Imhoff AB, Calvo E, Arce G, Shea K; Upper Extremity Committee of ISAKOS. ISAKOS upper extremity committee consensus statement on the need for diversification of the Rockwood classification for acromioclavicular joint injuries. Arthroscopy. 2014 Feb;30(2):271-8. doi: 10.1016/j.arthro.2013.11.005.
Nolte PC, Lacheta L, Dekker TJ, Elrick BP, Millett PJ. Optimal Management of Acromioclavicular Dislocation: Current Perspectives. Orthop Res Rev. 2020 Mar 5;12:27-44. doi: 10.2147/ORR.S218991. eCollection 2020.
Aliberti GM, Kraeutler MJ, Trojan JD, Mulcahey MK. Horizontal Instability of the Acromioclavicular Joint: A Systematic Review. Am J Sports Med. 2020 Feb;48(2):504-510. doi: 10.1177/0363546519831013. Epub 2019 Apr 23.
Cisneros LN, Reiriz JS. Prevalence of remaining horizontal instability in high-grade acromioclavicular joint injuries surgically managed. Eur J Orthop Surg Traumatol. 2017 Apr;27(3):323-333. doi: 10.1007/s00590-016-1898-0. Epub 2017 Jan 5.
Shin SJ, Kim NK. Complications after arthroscopic coracoclavicular reconstruction using a single adjustable-loop-length suspensory fixation device in acute acromioclavicular joint dislocation. Arthroscopy. 2015 May;31(5):816-24. doi: 10.1016/j.arthro.2014.11.013. Epub 2014 Dec 25.
Tauber M, Koller H, Hitzl W, Resch H. Dynamic radiologic evaluation of horizontal instability in acute acromioclavicular joint dislocations. Am J Sports Med. 2010 Jun;38(6):1188-95. doi: 10.1177/0363546510361951. Epub 2010 Apr 1.
Minkus M, Hann C, Scheibel M, Kraus N. Quantification of dynamic posterior translation in modified bilateral Alexander views and correlation with clinical and radiological parameters in patients with acute acromioclavicular joint instability. Arch Orthop Trauma Surg. 2017 Jun;137(6):845-852. doi: 10.1007/s00402-017-2691-1. Epub 2017 Apr 17.
Cano-Martinez JA, Nicolas-Serrano G, Bento-Gerard J, Picazo-Marin F, Andres-Grau J. Acute high-grade acromioclavicular dislocations treated with triple button device (MINAR): Preliminary results. Injury. 2016 Nov;47(11):2512-2519. doi: 10.1016/j.injury.2016.09.029. Epub 2016 Sep 15.
Scheibel M, Droschel S, Gerhardt C, Kraus N. Arthroscopically assisted stabilization of acute high-grade acromioclavicular joint separations. Am J Sports Med. 2011 Jul;39(7):1507-16. doi: 10.1177/0363546511399379. Epub 2011 Mar 24.
Sumanont S, Nopamassiri S, Boonrod A, Apiwatanakul P, Boonrod A, Phornphutkul C. Acromioclavicular joint dislocation: a Dog Bone button fixation alone versus Dog Bone button fixation augmented with acromioclavicular repair-a finite element analysis study. Eur J Orthop Surg Traumatol. 2018 Aug;28(6):1095-1101. doi: 10.1007/s00590-018-2186-y. Epub 2018 Mar 20.
Ladermann A, Grosclaude M, Lubbeke A, Christofilopoulos P, Stern R, Rod T, Hoffmeyer P. Acromioclavicular and coracoclavicular cerclage reconstruction for acute acromioclavicular joint dislocations. J Shoulder Elbow Surg. 2011 Apr;20(3):401-8. doi: 10.1016/j.jse.2010.08.007.
Cho CH, Kim BS, Kwon DH. Importance of additional temporary pin fixation combined coracoclavicular augmentation using a suture button device for acute acromioclavicular joint dislocation. Arch Orthop Trauma Surg. 2016 Jun;136(6):763-70. doi: 10.1007/s00402-016-2437-5. Epub 2016 Mar 10.
Vrgoc G, Japjec M, Jurina P, Gulan G, Jankovic S, Sebecic B, Staresinic M. Operative treatment of acute acromioclavicular dislocations Rockwood III and V-Comparative study between K-wires combined with FiberTape((R)) vs. TightRope System((R)). Injury. 2015 Nov;46 Suppl 6:S107-12. doi: 10.1016/j.injury.2015.10.053. Epub 2015 Nov 14.
Dyrna F, Imhoff FB, Haller B, Braun S, Obopilwe E, Apostolakos JM, Morikawa D, Imhoff AB, Mazzocca AD, Beitzel K. Primary Stability of an Acromioclavicular Joint Repair Is Affected by the Type of Additional Reconstruction of the Acromioclavicular Capsule. Am J Sports Med. 2018 Dec;46(14):3471-3479. doi: 10.1177/0363546518807908. Epub 2018 Nov 12.
Carkci E, Polat AE, Gurpinar T. The frequency of reduction loss after arthroscopic fixation of acute acromioclavicular dislocations using a double-button device, and its effect on clinical and radiological results. J Orthop Surg Res. 2020 Apr 8;15(1):136. doi: 10.1186/s13018-020-01674-x.
Ladermann A, Denard PJ, Collin P, Cau JBC, Van Rooij F, Piotton S. Early and delayed acromioclavicular joint reconstruction provide equivalent outcomes. J Shoulder Elbow Surg. 2021 Mar;30(3):635-640. doi: 10.1016/j.jse.2020.06.026. Epub 2020 Jul 7.
Other Identifiers
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Interventional
Identifier Type: -
Identifier Source: org_study_id
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