Clinical and Structural Outcome After Early Repair of the Traumatic Rotator Cuff Tear

Study Description

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The optimal timing for surgical repair of traumatic rotator cuff tears is controversial. Today there are no prospective studies investigating the short to mid-term outcome after early arthroscopic repair of traumatic rotator cuff tears and the Swedish National Musculoskeletal Competence Centre requests more research to this subject. The investigators will follow 60 patients with acute rotator cuff tear undergoing early rotator cuff repair during the first year after surgery.

The investigators hypothesise that the outcome after rotator cuff repair is good.

Condition or disease
Full Thickness Rotator Cuff Tear

Detailed Description:

There exists controversy in the current literature regarding timing for surgical repair of traumatic rotator cuff tears. We have seen no prospective studies describing the progression of shoulder function improvement the first year after arthroscopic rotator cuff repair.

We hypothesize that early arthroscopic repair of traumatic rotator cuff tears yields successful functional and structural outcomes but there will be a progression of shoulder function improvement during the hole first postoperative year.

Study Design

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	60 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	Arthroscopic Repair of Traumatic Rotator Cuff Tears. A Prospective Trial
Study Start Date :	November 2010
Actual Primary Completion Date :	October 2013
Actual Study Completion Date :	April 2014

Groups and Cohorts

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Western Ontario Rotator Cuff Index (WORC) [ Time Frame: Two years ]

Secondary Outcome Measures :

1. Constant Shoulder Score (CS) [ Time Frame: One year ]
2. standardised measure of health status with EQ-5D [ Time Frame: Two years ]
3. cuff integrity [ Time Frame: One year ]
4. Complications [ Time Frame: within one year ]

Biospecimen Retention:   Samples Without DNA

Peroperatively retained rotator cuff biopsy.

Eligibility Criteria

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

A prospective trial analysing the results after early arthroscopic repair of the traumatic rotator cuff tear. Every consecutive patient between Nov 2010 and Oct 2013 who fulfill the inclusion criteria are asked to participate after oral and written information. With a population of 250.000 we approximate an enrollment of 60 participants.

Criteria

Inclusion Criteria:

• trauma to the shoulder with sudden onset of symptoms
• asymptomatic shoulder before trauma
• mr positive for full thickness rotator cuff tear

Exclusion Criteria:

• fracture
• severe comorbidity
• more than 6 weeks after trauma
• glenohumeral degeneration signs or osteoarthritis on x-ray

Contacts and Locations

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Sweden
Department of Orthopaedic Surgery, Helsingborg Hospital
Helsingborg, Sweden, 25187

Sponsors and Collaborators

Helsingborgs Hospital

Investigators

Study Director:	Karl Lunsjo, Ass Prof	Helsingborgs Hospital

More Information

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Bassett RW, Cofield RH. Acute tears of the rotator cuff. The timing of surgical repair. Clin Orthop Relat Res. 1983 May;(175):18-24.

Lähteenmäki R, Lawrence S. Public biotech 2006 - the numbers. Nat Biotechnol. 2007 Jul;25(7):729-37.

Björnsson HC, Norlin R, Johansson K, Adolfsson LE. The influence of age, delay of repair, and tendon involvement in acute rotator cuff tears: structural and clinical outcomes after repair of 42 shoulders. Acta Orthop. 2011 Apr;82(2):187-92. doi: 10.3109/17453674.2011.566144. Epub 2011 Mar 24.

Petersen SA, Murphy TP. The timing of rotator cuff repair for the restoration of function. J Shoulder Elbow Surg. 2011 Jan;20(1):62-8. doi: 10.1016/j.jse.2010.04.045. Epub 2010 Aug 1.

Sørensen AK, Bak K, Krarup AL, Thune CH, Nygaard M, Jørgensen U, Sloth C, Torp-Pedersen S. Acute rotator cuff tear: do we miss the early diagnosis? A prospective study showing a high incidence of rotator cuff tears after shoulder trauma. J Shoulder Elbow Surg. 2007 Mar-Apr;16(2):174-80. Epub 2006 Dec 13.

Nho SJ, Adler RS, Tomlinson DP, Allen AA, Cordasco FA, Warren RF, Altchek DW, MacGillivray JD. Arthroscopic rotator cuff repair: prospective evaluation with sequential ultrasonography. Am J Sports Med. 2009 Oct;37(10):1938-45. doi: 10.1177/0363546509335764. Epub 2009 Jun 16.

Responsible Party:	Knut Aagaard, MD, MD., Lund University
ClinicalTrials.gov Identifier:	NCT01557309 History of Changes
Other Study ID Numbers:	KAstudy2
First Posted:	March 19, 2012
Last Update Posted:	August 17, 2016
Last Verified:	August 2016

Keywords provided by Knut Aagaard, MD, Lund University:

traumatic rotator cuff tear; arthroscopic rotator cuff repair; age; early rotator cuff repair

Additional relevant MeSH terms:

Rotator Cuff Injuries; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries