Clinical Outcome of Coracoclavicular Ligament Repair Using Autogenous Gracilis Tendon in Endobutton System.
NCT ID: NCT01759147
Last Updated: 2013-01-02
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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UNKNOWN
NA
10 participants
INTERVENTIONAL
2011-01-31
2013-07-31
Brief Summary
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The purpose of this study is to evaluate the clinical outcome and complications associated with coracoclavicular ligament repair using autogenous gracilis tendon graft implanted in a single transclavicle transcoracoid bone tunnel. The implantation is performed using an endobutton system that augments the repair with fibrewires.
The investigators will prospecitvely follow 30 patients enrolled in the study.
The hypthesis is that this near anatomical repair of the coracoclavicular ligaments will result in good clinical outcome and few complications.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Surgery
Surgical repair of acromioclavicular dislocation.
Surgical treatment of acromioclavicular dislocation.
Coracoclavicular ligament repair using autogenous gracilis tendon implanted using an endobutton system containing fibrewires and a single transclavicular, transcoracoid bone tunnel.
Interventions
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Surgical treatment of acromioclavicular dislocation.
Coracoclavicular ligament repair using autogenous gracilis tendon implanted using an endobutton system containing fibrewires and a single transclavicular, transcoracoid bone tunnel.
Eligibility Criteria
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Inclusion Criteria
* Shoulder trauma within last 2 weeks.
* Pain from the acromioclavicular joint.
Exclusion Criteria
* Previous acromioclavicular joint dislocation on contralateral side.
* Major shoulder pathology on affected side.
* Mental inability to take part in rehabilitation.
* Non Swedish or English speaking patients.
18 Years
75 Years
ALL
No
Sponsors
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Helsingborgs Hospital
OTHER
Responsible Party
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Jonas Nordin
Medical Intern
Principal Investigators
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Karl Lunsjö, Ass Prof
Role: STUDY_DIRECTOR
University of Lund
Locations
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Hospital of Helsingborg
Helsingborg, Skåne County, Sweden
Countries
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References
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DeBerardino TM, Pensak MJ, Ferreira J, Mazzocca AD. Arthroscopic stabilization of acromioclavicular joint dislocation using the AC graftrope system. J Shoulder Elbow Surg. 2010 Mar;19(2 Suppl):47-52. doi: 10.1016/j.jse.2009.12.014.
Mazzocca AD, Santangelo SA, Johnson ST, Rios CG, Dumonski ML, Arciero RA. A biomechanical evaluation of an anatomical coracoclavicular ligament reconstruction. Am J Sports Med. 2006 Feb;34(2):236-46. doi: 10.1177/0363546505281795. Epub 2005 Nov 10.
Lee SJ, Nicholas SJ, Akizuki KH, McHugh MP, Kremenic IJ, Ben-Avi S. Reconstruction of the coracoclavicular ligaments with tendon grafts: a comparative biomechanical study. Am J Sports Med. 2003 Sep-Oct;31(5):648-55. doi: 10.1177/03635465030310050301.
Costic RS, Labriola JE, Rodosky MW, Debski RE. Biomechanical rationale for development of anatomical reconstructions of coracoclavicular ligaments after complete acromioclavicular joint dislocations. Am J Sports Med. 2004 Dec;32(8):1929-36. doi: 10.1177/0363546504264637.
Wellmann M, Kempka JP, Schanz S, Zantop T, Waizy H, Raschke MJ, Petersen W. Coracoclavicular ligament reconstruction: biomechanical comparison of tendon graft repairs to a synthetic double bundle augmentation. Knee Surg Sports Traumatol Arthrosc. 2009 May;17(5):521-8. doi: 10.1007/s00167-009-0737-9. Epub 2009 Feb 19.
Yoo YS, Tsai AG, Ranawat AS, Bansal M, Fu FH, Rodosky MW, Smolinski P. A biomechanical analysis of the native coracoclavicular ligaments and their influence on a new reconstruction using a coracoid tunnel and free tendon graft. Arthroscopy. 2010 Sep;26(9):1153-61. doi: 10.1016/j.arthro.2009.12.031. Epub 2010 Apr 22.
Yoo JC, Ahn JH, Yoon JR, Yang JH. Clinical results of single-tunnel coracoclavicular ligament reconstruction using autogenous semitendinosus tendon. Am J Sports Med. 2010 May;38(5):950-7. doi: 10.1177/0363546509356976. Epub 2010 Mar 12.
Debski RE, Parsons IM 4th, Woo SL, Fu FH. Effect of capsular injury on acromioclavicular joint mechanics. J Bone Joint Surg Am. 2001 Sep;83(9):1344-51. doi: 10.2106/00004623-200109000-00009.
Other Identifiers
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JNStudy01
Identifier Type: -
Identifier Source: org_study_id
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