Clinical trial NCT02885714: ACCURATE Trial - Operative Treatment of Acute Rotator Cuff Tear Related to Trauma
Official title: ACCURATE Trial - Operative Treatment of Acute Rotator Cuff Tear Related to Trauma; a Placebo-controlled Efficacy Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Rotator Cuff Tear Related to Trauma
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2016-08-31
Enrollment: 180
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in Western Ontario Rotator Cuff index (WORC) compared to baseline at two years.
timeFrame: The change of WORC is also compared to baseline at 3 and 6 months, 1 , 2, 5 and 10 years
Secondary outcomes:
measure: Constant Score
timeFrame: 3 and 6 months, 1 , 2, 5 and 10 years
measure: Numeric rating scale of patients' shoulder pain during the last week at rest, during activity and at night.
timeFrame: 3 and 6 months, 1 , 2, 5 and 10 years
measure: 15D
timeFrame: 3 and 6 months, 1 , 2, 5 and 10 years
measure: Subjective patient satisfaction
timeFrame: 3 and 6 months, 1 , 2, 5 and 10 years
measure: Rotator cuff integrity in MRI investigation
timeFrame: 2, 5 and 10 years
measure: Development of osteoarthritic signs in radiographs
timeFrame: 2, 5 and 10 years
measure: Development of cuff tear arthropathy in radiographs
timeFrame: 2, 5 and 10 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Jyväskylä
country: Finland
facility: Central Finland Central Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Pori
country: Finland
facility: Satakunta Central Hospital
city: Tampere
country: Finland
facility: Hatanpää Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Vaasa
country: Finland
facility: Vaasa Central Hospital
city: Arendal
country: Norway
facility: Sørlandet sykehus HF
city: Oslo
country: Norway
facility: Oslo University Hospital, Ullevål Hospital
city: Sandvika
country: Norway
facility: Martina Hansens Hospital
city: Trondheim
country: Norway
facility: St. Olafs Hospital HF
city: Helsingborg
country: Sweden
facility: Skånevård Sund, Region Skåne
city: Kalmar
country: Sweden
facility: Kalmar County Hospital
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Varberg
country: Sweden
facility: Varberg Hospital
Study officials:
affiliation: Satakunta Central Hospital
name: Juha Kukkonen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Turku University Hospital
name: Anssi Ryösä, MD
role: STUDY_CHAIR
affiliation: University Hospital, Linkoeping
name: Hanna Björnsson Hallgren, MD, PhD
role: STUDY_CHAIR
affiliation: Martina Hansens Hospital
name: Stefan Moosmayer, MD, PhD
role: STUDY_CHAIR
affiliation: University Hospital, Linkoeping
name: Teresa Holmgren, PT, PhD
role: STUDY_CHAIR
affiliation: Kalmar County Hospital
name: Mats Ranebo, MD
role: STUDY_CHAIR
affiliation: Oslo University Hospital
name: Berte Bøe, MD, PhD
role: STUDY_CHAIR
affiliation: Turku University Hospital
name: Ville Äärimaa, Adj.Prof.
role: STUDY_DIRECTOR
References:
citation: Ryosa A, Kukkonen J, Bjornsson Hallgren HC, Moosmayer S, Holmgren T, Ranebo M, Boe B, Aarimaa 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.