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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Helsingborgs Hospital
Sponsor:
Information provided by (Responsible Party):
Knut Aagaard, MD, Lund University
ClinicalTrials.gov Identifier:
NCT01557309
First received: January 27, 2012
Last updated: March 16, 2012
Last verified: March 2012
  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

Further study details as provided by Helsingborgs Hospital:

Primary Outcome Measures:
  • Constant Shoulder Score (CS) [ Time Frame: twelve months ] [ Designated as safety issue: No ]
  • Western Ontario Rotator Cuff Index (WORC) [ Time Frame: twelve months ] [ Designated as safety issue: No ]
  • standardised measure of health status with EQ-5D [ Time Frame: twelve months ] [ Designated as safety issue: No ]
  • cuff integrity [ Time Frame: twelve months ] [ Designated as safety issue: No ]
    cuff integrity using MRI at one year follow up


Secondary Outcome Measures:
  • Complications [ Time Frame: within one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Peroperatively retained rotator cuff biopsy.


Estimated Enrollment: 60
Study Start Date: November 2010
Estimated Study Completion Date: January 2015
Estimated 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
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

Contacts
Contact: Knut Aagaard, MD +46-42-4063516 knut.aagaard@skane.se
Contact: Karl Lunsjo, Ass. Prof. +46-42-4063529 karl.lunsjo@skane.se

Locations
Sweden
Department of Orthopaedic Surgery, Helsingborg Hospital Recruiting
Helsingborg, Sweden, 25187
Contact: Knut Aagaard, MD    +46-42-4063516    knut.aagaard@skane.se   
Contact: Karl Lunsjo, Ass. Prof    +46-42-4063529    karl.lunsjo@skane.se   
Sponsors and Collaborators
Helsingborgs Hospital
Investigators
Study Director: Karl Lunsjo, Associate Prof Helsingborgs Hospital
  More Information

Publications:
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: March 16, 2012
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 October 23, 2014