Clinical and Structural Outcome After Early Repair of the Traumatic Rotator Cuff Tear - Full Text View

Purpose

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
Full Thickness Rotator Cuff Tear


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Arthroscopic Repair of Traumatic Rotator Cuff Tears. A Prospective Trial

Resource links provided by NLM:

MedlinePlus related topics: Tears

U.S. FDA Resources

Further study details as provided by Helsingborgs Hospital:

Primary Outcome Measures:

Western Ontario Rotator Cuff Index (WORC) [ Time Frame: Two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Constant Shoulder Score (CS) [ Time Frame: One year ] [ Designated as safety issue: No ]
standardised measure of health status with EQ-5D [ Time Frame: Two years ] [ Designated as safety issue: No ]
cuff integrity [ Time Frame: One year ] [ Designated as safety issue: No ]
Complications [ Time Frame: within one year ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Peroperatively retained rotator cuff biopsy.


Enrollment:	60
Study Start Date:	November 2010
Study Completion Date:	April 2014
Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

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.

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01557309

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

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
Study First Received:	January 27, 2012
Last Updated:	August 16, 2016
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Helsingborgs Hospital:


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

ClinicalTrials.gov processed this record on September 23, 2016