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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

Tracking Information
First Submitted Date  ICMJE August 19, 2016
First Posted Date  ICMJE August 31, 2016
Last Update Posted Date October 17, 2017
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02885714 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2016)
  • Constant Score [ Time Frame: 3 and 6 months, 1 , 2, 5 and 10 years ]
    Shoulder specific outcome measure combining subjective and objective variables
  • 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.
  • 15D [ Time Frame: 3 and 6 months, 1 , 2, 5 and 10 years ]
    Generic health-related quality of life instrument
  • Subjective patient satisfaction [ Time Frame: 3 and 6 months, 1 , 2, 5 and 10 years ]
    Patient reported scale for treatment satisfaction
  • Rotator cuff integrity in MRI investigation [ Time Frame: 2, 5 and 10 years ]
  • Development of osteoarthritic signs in radiographs [ Time Frame: 2, 5 and 10 years ]
  • Development of cuff tear arthropathy in radiographs [ Time Frame: 2, 5 and 10 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ACCURATE Trial - Operative Treatment of Acute Rotator Cuff Tear Related to Trauma
Official Title  ICMJE ACCURATE Trial - Operative Treatment of Acute Rotator Cuff Tear Related to Trauma; a Placebo-controlled Efficacy Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Rotator Cuff Tear Related to Trauma
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Placebo Comparator: Group I
    Placebo surgery + supervised specific exercises
    Intervention: Procedure: Placebo surgery and supervised specific exercises
  • Active Comparator: Group II
    Rotator cuff repair + supervised specific exercises
    Intervention: Procedure: Rotator cuff repair and supervised specific exercises
Publications * Ryösä A, Kukkonen J, Björnsson Hallgren HC, Moosmayer S, Holmgren T, Ranebo M, Bøe B, Äärimaa V; ACCURATE study group. Acute Cuff Tear Repair Trial (ACCURATE): protocol for a multicentre, randomised, placebo-controlled trial on the efficacy of arthroscopic rotator cuff repair. BMJ Open. 2019 May 19;9(5):e025022. doi: 10.1136/bmjopen-2018-025022.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 26, 2016)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2029
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anssi Ryösä, MD +35823138051 anssi.ryosa@tyks.fi
Contact: Ville Äärimaa, Adj.Prof. +35823130000 ville.aarimaa@tyks.fi
Listed Location Countries  ICMJE Finland,   Norway,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02885714
Other Study ID Numbers  ICMJE ACCURATE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Turku University Hospital
Study Sponsor  ICMJE Turku University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Turku University Hospital
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP