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ACCURATE Trial - Operative Treatment of Acute Rotator Cuff Tear Related to Trauma

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ClinicalTrials.gov Identifier: NCT02885714
Recruitment Status : Recruiting
First Posted : August 31, 2016
Last Update Posted : October 17, 2017
Sponsor:
Information provided by (Responsible Party):
Turku University Hospital

Brief Summary:

Rotator cuff tear is a very common and disabling condition that can be related to acute trauma such as falling on the shoulder. A tear is associated with symptoms such as pain in abduction, abduction weakness and night pain. Rotator cuff tear surgery is a well-established form of treatment in acute rotator cuff tears, although beneficial results have been reported for both conservative and surgical treatment of rotator cuff tears. Rotator cuff tear repair surgery involves a considerable amount of re-ruptures, and it is possible that the repaired tendon do not heal despite surgical repair. On the other hand rotator cuff tears are also found in completely asymptomatic persons and the clinical significance of a rupture may be generally lower than estimated. The above-mentioned factors, as well as recent research and meta-analysis on the treatment of mainly degenerative rotator cuff tears indicate that there is a limited evidence that surgery is not more effective in treating symptomatic rotator cuff tear than conservative treatment alone. However, these previous research findings cannot be applied directly to traumatic tears, although degeneration can be considered always to contribute to the creation of a rotator cuff tear.

During few last decades, despite the lack of evidence on the superiority of one treatment over another, the use of surgery to treat this disorder has been substantially increased. Treatment expectations are found to be important in predicting patient related outcome measures. In addition, surgery itself may produce a profound placebo effect. There are no previous placebo-controlled trials on the topic of interest. In order to find out the true efficacy of surgical treatment of acute, trauma related rotator cuff tears involving mainly the supraspinatus tendon, the investigators have designed this multi-centre, randomized, placebo-controlled efficacy trial.


Condition or disease Intervention/treatment Phase
Acute Rotator Cuff Tear Related to Trauma Procedure: Placebo surgery and supervised specific exercises Procedure: Rotator cuff repair and supervised specific exercises Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ACCURATE Trial - Operative Treatment of Acute Rotator Cuff Tear Related to Trauma; a Placebo-controlled Efficacy Trial
Study Start Date : December 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : January 2029

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Group I
Placebo surgery + supervised specific exercises
Procedure: Placebo surgery and supervised specific exercises
The patient is prepared for surgery as normal (plexus+general anesthesia or TIVA, with antibiotic prophylaxis). The arthroscope is introduced in the glenohumeral joint, and thereafter online randomization is performed. The joint space is evaluated. Nothing is to be removed or excised and the use of any vapour or shaver device is not allowed. The presence of a full-thickness rotator cuff tear is verified. Altogether 3 to 5 small stab wounds are made in typical locations resembling locations of typical rotator cuff repair. The time spent in the operating theatre with patients in placebo group should resemble the time spent with patients in the active treatment group and hence give an impression of a rotator cuff repair.

Active Comparator: Group II
Rotator cuff repair + supervised specific exercises
Procedure: Rotator cuff repair and supervised specific exercises
The patient is prepared for surgery as normal (plexus+general anesthesia or TIVA, with antibiotic prophylaxis). The arthroscope is introduced in the glenohumeral joint, and thereafter online randomization is performed. The joint space is evaluated and the presence of a full-thickness rotator cuff tear is verified. The cuff tear is repaired to its anatomic location using suture anchors according to surgeon preference. . A biceps tenotomy or tenodesis may be performed according to surgeon preference if the biceps tendon is noted to be frayed, unstable or inflamed. An additional acromioplasty may be performed according to surgeon preference.




Primary Outcome Measures :
  1. Change in Western Ontario Rotator Cuff index (WORC) compared to baseline at two years. [ Time Frame: The change of WORC is also compared to baseline at 3 and 6 months, 1 , 2, 5 and 10 years ]
    Patient reported disease specific outcome measure for rotator cuff conditions.


Secondary Outcome Measures :
  1. Constant Score [ Time Frame: 3 and 6 months, 1 , 2, 5 and 10 years ]
    Shoulder specific outcome measure combining subjective and objective variables

  2. Numeric rating scale of patients' shoulder pain during the last week at rest, during activity and at night. [ Time Frame: 3 and 6 months, 1 , 2, 5 and 10 years ]
    Subjective pain intensity measure. The numeric pain rating scale (pain NRS). Scale 0 to 10. 0 = no pain and 10 = worst possible pain.

  3. 15D [ Time Frame: 3 and 6 months, 1 , 2, 5 and 10 years ]
    Generic health-related quality of life instrument

  4. Subjective patient satisfaction [ Time Frame: 3 and 6 months, 1 , 2, 5 and 10 years ]
    Patient reported scale for treatment satisfaction

  5. Rotator cuff integrity in MRI investigation [ Time Frame: 2, 5 and 10 years ]
  6. Development of osteoarthritic signs in radiographs [ Time Frame: 2, 5 and 10 years ]
  7. Development of cuff tear arthropathy in radiographs [ Time Frame: 2, 5 and 10 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age of patient over 45 and below 70 years
  2. Acute onset of shoulder symptoms after a traumatic event (any kind of sudden stretch, pull, fall, or impact, on the shoulder that is associated with the onset of symptoms)
  3. Shoulder symptoms relating to rotator cuff tear = pain laterally on the shoulder and/or painful motion arc during abduction or flexion
  4. MRI documented full thickness supraspinatus (ssp) tear

Exclusion Criteria:

  1. Traumatic event of the shoulder due a criminal act of violence with legal consequences
  2. A delay of more than 4 months after the onset of symptoms of trauma to the day of intervention
  3. Arthroscopically documented partial thickness rotator cuff tear only
  4. A large MRI documented full thickness rotator cuff tear, sagittal tear size at the level of footprint larger than 3cm
  5. MRI or arthroscopically documented total width of infraspinatus (isp) or subscapularis (ssc) tear
  6. MRI or arthroscopically documented fully dislocated biceps tendon (biceps out of the groove) with concomitant subscapularis tear
  7. Positive clinical rotatory lag sign (ER1 lag (>10 degrees), lift off lag (involuntary drop against the back), horn blower lag (involuntary internal rotation of the forearm in supported elevated position))
  8. Marked fatty degeneration in any of the cuff muscles (more than Fuchs/Goutallier grade 2)
  9. Radiographically or MRI documented concomitant fracture line of the involved extremity or bony avulsion of the torn tendon or dislocation of the humeral head or the acromioclavicular joint.
  10. Concomitant clinically detectable motoric nerve injury affecting the shoulder
  11. Radiographically documented severe osteoarthritis of the glenohumeral joint, Samilson-Prieto 2 or above
  12. Non-congruency of the glenohumeral joint in radiographs (Hamada stage 2 or above)
  13. Clinical stiffness of the glenohumeral joint (severely limited passive range of motion: glenohumeral external rotation < 30 degrees, and abduction with stabilized scapula <60 degrees)
  14. Previous surgery of the affected shoulder (affecting clavicle, scapula or upper third of the humerus)
  15. Earlier sonographic or MRI finding of a rotator cuff tear
  16. Previous symptoms of the ipsilateral shoulder requiring conservative treatment (glucocorticosteroid injections and/or physiotherapy) delivered by health care professionals during the last five years
  17. Systemic glucocorticosteroid or antimetabolite medication during the last 5 years
  18. Ongoing treatment for malignancy
  19. ASA classification 3 or 4
  20. Patient's inability to understand written and spoken Finnish, Norwegian or Swedish
  21. History of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardise informed consent
  22. Patients with a contraindication/noncomplience for MRI examination or use of electrocautery devices
  23. Previous randomization of the contralateral shoulder into the ACCURATE trial
  24. Patient's denial for operative treatment and/or participation in the trial

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): NCT02885714


Contacts
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Contact: Anssi Ryösä, MD +35823138051 anssi.ryosa@tyks.fi
Contact: Ville Äärimaa, Adj.Prof. +35823130000 ville.aarimaa@tyks.fi

Locations
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Finland
Helsinki University Hospital Not yet recruiting
Helsinki, Finland
Central Finland Central Hospital Not yet recruiting
Jyväskylä, Finland
Contact: Juha Paloneva, Adj.Prof.         
Kuopio University Hospital Not yet recruiting
Kuopio, Finland
Contact: Antti Joukainen, MD, PhD         
Oulu University Hospital Not yet recruiting
Oulu, Finland
Contact: Tapio Flinkkilä, Adj.Prof.         
Satakunta Central Hospital Recruiting
Pori, Finland
Contact: Juha Kukkonen, MD, PhD    +358 2 62771    jupeku@utu.fi   
Hatanpää Hospital Not yet recruiting
Tampere, Finland
Contact: Janne Lehtinen, Adj. Prof.         
Tampere University Hospital Not yet recruiting
Tampere, Finland
Contact: Antti Launonen, MD, PhD         
Turku University Hospital Recruiting
Turku, Finland
Contact: Anssi Ryösä, MD    +35823138051    anssi.ryosa@tyks.fi   
Contact: Ville Äärimaa, Adj.Prof.    +35823130000    ville.aarimaa@tyks.fi   
Vaasa Central Hospital Recruiting
Vaasa, Finland
Contact: Pauli Sjöblom, MD         
Norway
Sørlandet sykehus HF Recruiting
Arendal, Norway
Contact: Sigurd Liavaag, MD, PhD         
Oslo University Hospital, Ullevål Hospital Recruiting
Oslo, Norway
Contact: Berte Bøe, MD, PhD       berte2@mac.com   
Martina Hansens Hospital Recruiting
Sandvika, Norway
Contact: Stefan Moosmayer, MD, PhD    +47 90723909    st.moos@online.no   
St. Olafs Hospital HF Recruiting
Trondheim, Norway
Contact: Bernd Wünsche, MD         
Sweden
Skånevård Sund, Region Skåne Recruiting
Helsingborg, Sweden
Contact: Knut Aagaard, MD         
Kalmar County Hospital Recruiting
Kalmar, Sweden
Contact: Mats Ranebo, MD    +46 480 81432    matsra@ltkalmar.se   
Linköping University Hospital Recruiting
Linköping, Sweden
Contact: Hanna Björnsson Hallgren, MD, PhD    +46 709-473276    hanna.bjornsson.hallgren@regionostergotland.se   
Varberg Hospital Recruiting
Varberg, Sweden
Contact: Sven Gredevik, MD         
Sponsors and Collaborators
Turku University Hospital
Investigators
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Principal Investigator: Juha Kukkonen, MD, PhD Satakunta Central Hospital
Study Chair: Anssi Ryösä, MD Turku University Hospital
Study Chair: Hanna Björnsson Hallgren, MD, PhD University Hospital, Linkoeping
Study Chair: Stefan Moosmayer, MD, PhD Martina Hansens Hospital
Study Chair: Teresa Holmgren, PT, PhD University Hospital, Linkoeping
Study Chair: Mats Ranebo, MD Kalmar County Hospital
Study Chair: Berte Bøe, MD, PhD Oslo University Hospital
Study Director: Ville Äärimaa, Adj.Prof. Turku University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT02885714     History of Changes
Other Study ID Numbers: ACCURATE
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Wounds and Injuries
Rotator Cuff Injuries
Rupture
Shoulder Injuries
Tendon Injuries