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

This study has been completed.
Information provided by (Responsible Party):
Knut Aagaard, MD, Lund University Identifier:
First received: January 27, 2012
Last updated: August 16, 2016
Last verified: August 2016

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.

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:

Further study details as provided by Knut Aagaard, MD, Lund University:

Primary Outcome Measures:
  • Western Ontario Rotator Cuff Index (WORC) [ Time Frame: Two years ]

Secondary Outcome Measures:
  • Constant Shoulder Score (CS) [ Time Frame: One year ]
  • standardised measure of health status with EQ-5D [ Time Frame: Two years ]
  • cuff integrity [ Time Frame: One year ]
  • Complications [ Time Frame: within one year ]

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.


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.

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 identifier: NCT01557309

Department of Orthopaedic Surgery, Helsingborg Hospital
Helsingborg, Sweden, 25187
Sponsors and Collaborators
Helsingborgs Hospital
Study Director: Karl Lunsjo, Ass Prof Helsingborgs Hospital
  More Information

Responsible Party: Knut Aagaard, MD, MD., Lund University Identifier: NCT01557309     History of Changes
Other Study ID Numbers: KAstudy2
Study First Received: January 27, 2012
Last Updated: August 16, 2016

Keywords provided by Knut Aagaard, MD, Lund University:
traumatic rotator cuff tear
arthroscopic rotator cuff repair
early rotator cuff repair processed this record on September 20, 2017