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

Full Thickness Rotator Cuff Tear Clinical Trial

Official title:

Arthroscopic Repair of Traumatic Rotator Cuff Tears. A Prospective Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01557309
• Other study ID #: KAstudy2
• Status: Completed
• Phase: N/A
• First received: January 27, 2012
• Last updated: August 16, 2016
• Start date: November 2010
• Est. completion date: April 2014

Study information

• Verified date: August 2016
• Source: Helsingborgs Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Full Thickness Rotator Cuff Tear

Locations

Country	Name	City	State
Sweden	Department of Orthopaedic Surgery, Helsingborg Hospital	Helsingborg

Sponsors (1)

Lead Sponsor	Collaborator
Helsingborgs Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

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

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Ontario Rotator Cuff Index (WORC)		Two years	No
Secondary	Constant Shoulder Score (CS)		One year	No
Secondary	standardised measure of health status with EQ-5D		Two years	No
Secondary	cuff integrity		One year	No
Secondary	Complications		within one year	No