Clinical Outcome of Coracoclavicular Ligament Repair Using Autogenous Gracilis Tendon in Endobutton System. - Full Text View

Purpose

There are many surgical methods available for the treatment of patients with acromioclavicular dislocations. No single method has yet proven to be superior to the others.

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.

Condition	Intervention
Acromioclavicular Joint Dislocation.	Procedure: Surgical treatment of acromioclavicular dislocation.

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Case Series to Evaluate Clinical Outcome of Coracoclavicular Ligament Repair Using Autogenous Gracilis Tendon in Endobutton System.

Resource links provided by NLM:

MedlinePlus related topics: Dislocations Shoulder Injuries and Disorders

U.S. FDA Resources

Further study details as provided by Helsingborgs Hospital:

Primary Outcome Measures:

Complication [ Time Frame: 12 months after surgery. ] [ Designated as safety issue: Yes ]
- Redislocations.
- Other local complications, eg. infection.
Disabilities of the Arm, Shoulder and Hand Score [ Time Frame: 12 months after surgery. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Constant-Murley Score [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]

Enrollment:	10
Study Start Date:	January 2011
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Surgery Surgical repair of acromioclavicular dislocation.	Procedure: 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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age between 18 and 75 years old.
Shoulder trauma within last 2 weeks.
Pain from the acromioclavicular joint.

Exclusion Criteria:

Chronic or concomitant acromioclavicular joint pathology on injured side.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01759147

Locations

Sweden
Hospital of Helsingborg
Helsingborg, Skåne, Sweden

Sponsors and Collaborators

Helsingborgs Hospital

Investigators

Study Director:

Karl Lunsjö, Ass Prof

University of Lund

More Information

Publications:

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. Epub 2005 Nov 10. PubMed PMID: 16282577.

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.

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.

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-A(9):1344-51.

Responsible Party:	Jonas Nordin, Medical Intern, Helsingborgs Hospital
ClinicalTrials.gov Identifier:	NCT01759147 History of Changes
Other Study ID Numbers:	JNStudy01
Study First Received:	December 23, 2012
Last Updated:	December 23, 2012
Health Authority:	Sweden: Regional Ethics Committee Lund

Additional relevant MeSH terms:

Dislocations
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2013