ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01557309
Recruitment Status : Completed
First Posted : March 19, 2012
Last Update Posted : August 17, 2016
Sponsor:
Information provided by (Responsible Party):
Knut Aagaard, MD, Lund University

Study Description
Go to 
Top of Page 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 
Top of Page 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page 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 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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    Key Record Dates
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