NCT05844098

Brief Summary

This RCT study is designed for comparing functional outcomes and radioligic outcomes 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?

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

7 months

First QC Date

February 16, 2023

Last Update Submit

October 23, 2024

Conditions

Acromioclavicular Joint Dislocation

Keywords

Arthroscopic assisted CC-stabilizationAC joint injury

Outcome Measures

Primary Outcomes (1)

  • Acromioclavicular Joint Instability (ACJI) score

    Functional outcome, Rated from 0-100, higher score means better function of the shoulder

    1 year post-operative

Secondary Outcomes (5)

  • Coracoclavicular (CC) distance diference

    Postoperative day 1, 2weeks postop, 6weeks postop, 3months postop, 6 months postop, 1 year postop

  • Gleno-acromio-clavicular angle (GACA) difference

    3months postop, 6 months postop, 1 year postop

  • Constant score

    3months postop, 6 months postop, 1 year postop

  • DASH score

    3months postop, 6 months postop, 1 year postop

  • VAS

    3months postop, 6 months postop, 1 year postop

Study Arms (2)

With K-wire

EXPERIMENTAL

arthroscopic assisted CC-stabilization with K-wire

Device: K-wire

No K-wire

NO INTERVENTION

arthroscopic assisted CC-stabilization

Interventions

K-wireDEVICE

K-wire No. 2.0 insertion was done additionally from arthroscopic assisted CC-stabilization by inserting K-wire from acromion process to distal clavicle.

With K-wire

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-45 years old
  • Acute AC joint injury rockwood classification III, IV and V

You may not qualify if:

  • History of underwent previous ipsilateral shoulder surgery
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Savang Vadhana Memorial Hospital

Chon Buri, 20110, Thailand

RECRUITING

Related Publications (18)

  • 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.

    PMID: 31008872BACKGROUND

  • 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.

    PMID: 5702953BACKGROUND

  • 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.

    PMID: 24485119BACKGROUND

  • 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.

    PMID: 32184680BACKGROUND

  • 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.

    PMID: 31013137BACKGROUND

  • 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.

    PMID: 28054147BACKGROUND

  • 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.

    PMID: 25543250BACKGROUND

  • 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.

    PMID: 20360606BACKGROUND

  • 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.

    PMID: 28417201BACKGROUND

  • 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.

    PMID: 27663286BACKGROUND

  • 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.

    PMID: 21436458BACKGROUND

  • 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.

    PMID: 29557509BACKGROUND

  • 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.

    PMID: 20888260BACKGROUND

  • 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.

    PMID: 26965695BACKGROUND

  • 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.

    PMID: 26584732BACKGROUND

  • 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.

    PMID: 30419178BACKGROUND

  • 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.

    PMID: 32268914BACKGROUND

  • 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.

    PMID: 32650071BACKGROUND

MeSH Terms

Interventions

Bone Wires

Intervention Hierarchy (Ancestors)

Internal FixatorsProstheses and ImplantsEquipment and SuppliesOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentSurgical Fixation Devices

Study Officials

  • Nachapong Sithiwichankit, MD

    QSMVH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nachapong Sithiwichankit, M.D

CONTACT

+66038320200leang1698@hotmail.com

Surasak Srimongkolpitak, M.D

CONTACT

+66038320200

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2023

First Posted

May 6, 2023

Study Start

April 1, 2024

Primary Completion

October 30, 2024

Study Completion

December 30, 2024

Last Updated

October 26, 2024

Record last verified: 2024-10

Locations

TH(1)