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Active, Not Recruiting

NCT Number: NCT00695981

Operative Versus Non-operative Management of Rotator Cuff Tear

This study aims at determining the effectiveness and cost-effectiveness of surgical management of full-thickness rotator cuff tears compared to conservative treatment. The research setting is prospective, randomised, and controlled.

The aim of the study is to search out evidence based data of indications for rotator cuff repair. The investigators also aim at offering patients the most efficient and effective treatment and reduce the number of operations that do not have sufficient effectiveness. The data obtained will facilitate developing guidelines for referrals to a specialist when rotator cuff tear is suspected.

The investigators hypothesize that there are subgroups of patients suffering from rotator cuff tears that benefit from surgery whereas other subgroups are best treated conservatively.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Rotator Cuff Tear Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Helsinki, Helsinki, Finland

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About this study

Subgroup analyses:

  • age
  • sex
  • duration of symptoms
  • presence of trauma before symptoms
  • size of tear
  • degenerative findings
  • other findings in MRI or arthroscopy
  • type of operation
  • co-morbidities
  • occupation
  • pain (VAS)
  • objective shoulder function
  • activities of daily living

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age over 35 years old
  • duration of symptoms at least three months despite of non-operative treatment
  • the patient accepts both treatment options (operative and conservative)
  • a full-thickness rotator cuff tear in MRI arthrography

Exclusion criteria

  • previous shoulder operations
  • too high risk for operation
  • any disease or social problem reducing the ability to co-operate
  • rheumatoid arthritis
  • severe arthrosis of the glenohumeral or acromioclavicular joint
  • irreparable rotator cuff tear (including rotator cuff tear arthropathy)
  • progressive malign disease
  • adhesive capsulitis
  • high-energy trauma before symptoms
  • cervical syndrome
  • shoulder instability

Treatment and study plan

Rotator Cuff Repair

Procedure

Rotator cuff repair + physical therapy according to a standardized protocol

Other names: Arthroscopic or open rotator cuff repair

Conservative treatment

Procedure

Physiotherapy according to a standardized protocol

Other names: Physical therapy, Non-operative treatment

Primary outcomes

  1. Change in pain (VAS) and objective shoulder function (Constant score)

    Time frame: 24 months

    VAS (0 to 100 mm), Constant score (0 to 100 points)

Secondary outcomes

  1. Change in pain (VAS) and objective shoulder function (Constant score)

    Time frame: 3 months

    VAS (0 to 100 mm), Constant score (0 to 100 points)

  2. Change in pain (VAS) and objective shoulder function (Constant score)

    Time frame: 6 months

    VAS (0 to 100 mm), Constant score (0 to 100 points)

  3. Change in pain (VAS) and objective shoulder function (Constant score)

    Time frame: 12 months

    VAS (0 to 100 mm), Constant score (0 to 100 points)

  4. Change in pain (VAS) and objective shoulder function (Constant score)

    Time frame: 5 years

    VAS (0 to 100 mm), Constant score (0 to 100 points)

Sponsors and collaborators

Lead sponsor

Central Finland Hospital District

Other

Collaborators

  • Academy of Finland
  • Oulu University Hospital

Registry information

Official study title

The Effectiveness and Cost-Effectiveness of Operative and Non-operative Management of Rotator Cuff Tear

Important dates

Study start
2008
Primary completion
2017
Study completion
2028
First posted
Jun 12, 2008
Registry last updated
Aug 22, 2024

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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