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Completed

NCT Number: NCT01557309

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

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.

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Key information

Conditions

Full Thickness Rotator Cuff Tear

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Orthopaedic Surgery, Helsingborg Hospital

Helsingborg, 25187, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Western Ontario Rotator Cuff Index (WORC)

    Time frame: Two years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Helsingborgs Hospital

Other

Registry information

Official study title

Arthroscopic Repair of Traumatic Rotator Cuff Tears. A Prospective Trial

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Mar 19, 2012
Registry last updated
Aug 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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