Acromioclavicular Joint Dislocation. Clinical Trial
Official title:
Case Series to Evaluate Clinical Outcome of Coracoclavicular Ligament Repair Using Autogenous Gracilis Tendon in Endobutton System.
| Verified date | December 2012 |
| Source | Helsingborgs Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: Regional Ethics Committee Lund |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 10 |
| Est. completion date | July 2013 |
| Est. primary completion date | January 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Hospital of Helsingborg | Helsingborg | Skåne |
| Lead Sponsor | Collaborator |
|---|---|
| Helsingborgs Hospital |
Sweden,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Complication | Redislocations. Other local complications, eg. infection. |
12 months after surgery. | Yes |
| Primary | Disabilities of the Arm, Shoulder and Hand Score | 12 months after surgery. | No | |
| Secondary | Constant-Murley Score | 12 months after surgery | No |