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RecruitingNCT05844098Updated Oct 26, 2024

Arthroscopic Assisted CC Stabilization Alone VS Additional K-wire Fixation for Acute Acromioclavicular Joint Injury

An interventional study of K-wire in Acromioclavicular Joint Dislocation, sponsored by Queen Savang Vadhana Memorial Hospital, Thailand. Recruiting at 1 site in Thailand. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-10-26.

Sponsored by Queen Savang Vadhana Memorial Hospital, Thailand · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as recruiting.
  • Started Apr 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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?
Read the detailed description

Acromioclavicular joint injury (ACJI) is one of the most common injury of shoulder joint. Most common mechanism of injury is from direct force apply to the affected shoulder, in adduction position, in acromion process area. Most of the intervention that have been used for treat ACJI are focused on pain control, maintain the strength of the joint, no limitation in daily life activity and full range of motion of affected shoulder. Operative treatment is indicated in ACJI Rockwood classification grade III, IV, V, and VI. Nowadays there are over 60 surgical techniques without gold standard. Arthroscopic assisted CC-stabilzation is one of the most popular technique that has been used for ACJI.

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?
02

Conditions studied

  • Acromioclavicular Joint Dislocation

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Keywords

  • Arthroscopic assisted CC-stabilization
  • AC joint injury
03

In context

Joint Dislocations

98 studies on the registry are indexed under Joint Dislocations; 21 are open to participants now.

This study's planned enrollment of 20 is below the median of 50 across 60 interventional studies indexed under Joint Dislocations.

Browse Joint Dislocations studies →

Lead sponsor

Queen Savang Vadhana Memorial Hospital, Thailand is the lead sponsor of 29 studies on the registry; 15 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    With K-wire

    arthroscopic assisted CC-stabilization with K-wire

    Device: K-wire

  • No intervention
    No K-wire

    arthroscopic assisted CC-stabilization

Interventions

  • DeviceK-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.

06

What researchers measure

Primary outcomes

  1. Acromioclavicular Joint Instability (ACJI) score

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

    Time frame: 1 year post-operative

Secondary outcomes

  1. Coracoclavicular (CC) distance diference

    Radiologic outcome

    Time frame: Postoperative day 1, 2weeks postop, 6weeks postop, 3months postop, 6 months postop, 1 year postop

  2. Gleno-acromio-clavicular angle (GACA) difference

    Radiologic outcome

    Time frame: 3months postop, 6 months postop, 1 year postop

  3. Constant score

    Functional outcome, Score from 0-100, Higher score means better shoulder function

    Time frame: 3months postop, 6 months postop, 1 year postop

  4. DASH score

    Functional outcome, Score from 0-100, 0 means no disabillity, 100 means most severe disabillity

    Time frame: 3months postop, 6 months postop, 1 year postop

  5. VAS

    Functional outcome, Scale from 0-10, Lower score means better outcome

    Time frame: 3months postop, 6 months postop, 1 year postop

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 31008872 ↗
  • 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. PubMed 5702953 ↗
  • 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. PubMed 24485119 ↗
  • 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. PubMed 32184680 ↗
  • 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. PubMed 31013137 ↗
  • 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. PubMed 28054147 ↗
  • 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. PubMed 25543250 ↗
  • 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. PubMed 20360606 ↗
  • 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. PubMed 28417201 ↗
  • 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. PubMed 27663286 ↗
  • 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. PubMed 21436458 ↗
  • 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. PubMed 29557509 ↗
  • 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. PubMed 20888260 ↗
  • 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. PubMed 26965695 ↗
  • 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. PubMed 26584732 ↗
  • 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. PubMed 30419178 ↗
  • 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. PubMed 32268914 ↗
  • 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. PubMed 32650071 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2024 (actual). Primary completion is estimated for Oct 2024, 6 months after the start.

Of 24 interventional studies with no phase under Joint Dislocations, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 68. This study's planned 6 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 16, 2023
First posted
May 6, 2023
StartActual
Apr 1, 2024
Primary completionEst.
Oct 30, 2024
CompletionEst.
Dec 30, 2024
Last update
Oct 26, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05844098
Lead sponsor
Queen Savang Vadhana Memorial Hospital, Thailand
Responsible party
Sponsor
First posted
May 6, 2023
Start date
Apr 1, 2024
Primary completion
Oct 30, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Oct 26, 2024

Study contacts

Nachapong Sithiwichankit, M.D
Contact
leang1698@hotmail.com
+66038320200
Surasak Srimongkolpitak, M.D
Contact
+66038320200
Nachapong Sithiwichankit, MD
principal investigator · QSMVH

Oversight

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

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