Clinical Outcome of Coracoclavicular Ligament Repair Using Autogenous Gracilis Tendon in Endobutton System.

NCT01759147 | Unknown

• 1 other identifier: JNStudy01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acromioclavicular Joint Dislocation.

Outcome Measures

Primary Outcomes (2)

• Complication

  * Redislocations. * Other local complications, eg. infection.

  12 months after surgery.

• Disabilities of the Arm, Shoulder and Hand Score

  12 months after surgery.

Secondary Outcomes (1)

• Constant-Murley Score

  12 months after surgery

Study Arms (1)

Surgery

EXPERIMENTAL

Surgical repair of acromioclavicular dislocation.

Procedure: Surgical treatment of acromioclavicular dislocation.

Interventions

Surgical treatment of acromioclavicular dislocation. PROCEDURE

Coracoclavicular ligament repair using autogenous gracilis tendon implanted using an endobutton system containing fibrewires and a single transclavicular, transcoracoid bone tunnel.

Surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helsingborgs Hospital: lead

Study Sites (1)

Hospital of Helsingborg

Helsingborg, Skåne County, Sweden

Location

Related Publications (8)

• 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.

  PMID: 20188268 BACKGROUND

• 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.

  PMID: 16282577 BACKGROUND

• 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.

  PMID: 12975181 BACKGROUND

• 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.

  PMID: 15572323 BACKGROUND

• 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.

  PMID: 19225755 BACKGROUND

• 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.

  PMID: 20810076 BACKGROUND

• 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.

  PMID: 20228243 BACKGROUND

• 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.

  PMID: 11568197 BACKGROUND

Study Officials

• Karl Lunsjö, Ass Prof

  University of Lund

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Intern

Study Record Dates

• First Submitted: December 23, 2012
• First Posted: January 2, 2013
• Study Start: January 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: July 1, 2013
• Last Updated: January 2, 2013

Record last verified: 2012-12

Locations

SE (1)