Acromioclavicular Joint Dislocation.NCT01759147
Clinical Outcome of Coracoclavicular Ligament Repair Using Autogenous Gracilis Tendon in Endobutton System.
A study testing Surgical treatment of acromioclavicular dislocation. in people with Acromioclavicular Joint Dislocation., run by Helsingborgs Hospital at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acromioclavicular Joint Dislocation.
- What is being tested?
- Surgical treatment of acromioclavicular dislocation.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2011to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years old.
- Shoulder trauma within last 2 weeks.
- Pain from the acromioclavicular joint.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Case Series to Evaluate Clinical Outcome of Coracoclavicular Ligament Repair Using Autogenous Gracilis Tendon in Endobutton System.
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.
Read more
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.
- Being tested
- Surgical treatment of acromioclavicular dislocation.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical treatment of acromioclavicular dislocation.Procedure or surgery
Coracoclavicular ligament repair using autogenous gracilis tendon implanted using an endobutton system containing fibrewires and a single transclavicular, transcoracoid bone tunnel.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | Surgical repair of acromioclavicular dislocation. Receives: Procedure: Surgical treatment of acromioclavicular dislocation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication
- Redislocations.
- Other local complications, eg. infection.
Measured: 12 months after surgery.
Disabilities of the Arm, Shoulder and Hand Score
Measured: 12 months after surgery.
Secondary outcomes (1)
Constant-Murley Score
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2013 (estimated)
- Study startJan 2011
- Primary completionJan 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Acromioclavicular Joint Dislocation.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsingborgs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonas Nordin, Helsingborgs Hospital
- Investigators
- Karl Lunsjö, Ass Prof, Study director, University of Lund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759147
- Sponsor's protocol ID
- JNStudy01
- Status last verified
- Dec 2012
- First submitted
- 23 Dec 2012
- Last updated
- 2 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 20188268Mazzocca 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.
PubMed 16282577Lee 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.
PubMed 12975181Costic 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.
PubMed 15572323Wellmann 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.
PubMed 19225755Yoo 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.
PubMed 20810076Yoo 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.
PubMed 20228243Debski 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.
PubMed 11568197
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Series to Evaluate Clinical Outcome of Coracoclavicular Ligament Repair Using Autogenous Gracilis Tendon in Endobutton System.
- ClinicalTrials.gov ID
- NCT01759147
- Acronym / sponsor ID
- JNStudy01
- Conditions
- Acromioclavicular Joint Dislocation.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Helsingborgs HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 2 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Procedure: Surgical treatment of acromioclavicular dislocation.Surgical repair of acromioclavicular dislocation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 75 years old.
- Shoulder trauma within last 2 weeks.
- Pain from the acromioclavicular joint.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Surgery |
Primary outcome
Complication
Time frame: 12 months after surgery.
* Redislocations. * Other local complications, eg. infection.
Disabilities of the Arm, Shoulder and Hand Score
Time frame: 12 months after surgery.
1 secondary outcome
Constant-Murley Score
Time frame: 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2013.
- Background: PubMed 20188268DeBerardino 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.
- Background: PubMed 16282577Mazzocca 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.
- Background: PubMed 12975181Lee 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.
- Background: PubMed 15572323Costic 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.
- Background: PubMed 19225755Wellmann 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.
- Background: PubMed 20810076Yoo 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.
- Background: PubMed 20228243Yoo 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.
- Background: PubMed 11568197Debski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl Lunsjö, Ass Prof study director
University of Lund
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical treatment of acromioclavicular dislocation. in people with Acromioclavicular Joint Dislocation., run by Helsingborgs Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication (time frame: 12 months after surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01759147, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2013.