Clinical trial NCT01557309: Clinical and Structural Outcome After Early Repair of the Traumatic Rotator Cuff Tear
Official title: Arthroscopic Repair of Traumatic Rotator Cuff Tears. A Prospective Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Full Thickness Rotator Cuff Tear
Keywords: traumatic rotator cuff tear
arthroscopic rotator cuff repair
age
early rotator cuff repair
Lead sponsor: Helsingborgs Hospital
Sponsor class: OTHER
First posted: 2012-03-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: Western Ontario Rotator Cuff Index (WORC)
timeFrame: Two years
Secondary outcomes:
measure: Constant Shoulder Score (CS)
timeFrame: One year
measure: standardised measure of health status with EQ-5D
timeFrame: Two years
measure: cuff integrity
timeFrame: One year
measure: Complications
timeFrame: within one year
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Department of Orthopaedic Surgery, Helsingborg Hospital
Study officials:
affiliation: Helsingborgs Hospital
name: Karl Lunsjo, Ass Prof
role: STUDY_DIRECTOR
References:
citation: Bassett RW, Cofield RH. Acute tears of the rotator cuff. The timing of surgical repair. Clin Orthop Relat Res. 1983 May;(175):18-24.
citation: Lahteenmaki R, Lawrence S. Public biotech 2006 - the numbers. Nat Biotechnol. 2007 Jul;25(7):729-37. doi: 10.1038/nbt0707-729. No abstract available.
citation: Bjornsson 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.
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.
citation: Sorensen AK, Bak K, Krarup AL, Thune CH, Nygaard M, Jorgensen 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. doi: 10.1016/j.jse.2006.06.010. Epub 2006 Dec 13.
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.