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

NCT ID: NCT02885714

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2025-01-31

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.

Conditions

Acute Rotator Cuff Tear Related to Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group I

Placebo surgery + supervised specific exercises

Group Type: PLACEBO_COMPARATOR

Placebo surgery and supervised specific exercises

Intervention Type: PROCEDURE

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.

Group II

Rotator cuff repair + supervised specific exercises

Group Type: ACTIVE_COMPARATOR

Rotator cuff repair and supervised specific exercises

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Turku University Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juha Kukkonen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Satakunta Central Hospital

Anssi Ryösä, MD

Role: STUDY_CHAIR

Turku University Hospital

Hanna Björnsson Hallgren, MD, PhD

Role: STUDY_CHAIR

University Hospital, Linkoeping

Stefan Moosmayer, MD, PhD

Role: STUDY_CHAIR

Martina Hansens Hospital

Teresa Holmgren, PT, PhD

Role: STUDY_CHAIR

University Hospital, Linkoeping

Mats Ranebo, MD

Role: STUDY_CHAIR

Kalmar County Hospital

Berte Bøe, MD, PhD

Role: STUDY_CHAIR

Oslo University Hospital

Ville Äärimaa, Adj.Prof.

Role: STUDY_DIRECTOR

Turku University Hospital

Locations

Helsinki University Hospital

Helsinki, , Finland

Central Finland Central Hospital

Jyväskylä, , Finland

Kuopio University Hospital

Kuopio, , Finland

Oulu University Hospital

Oulu, , Finland

Satakunta Central Hospital

Pori, , Finland

Hatanpää Hospital

Tampere, , Finland

Tampere University Hospital

Tampere, , Finland

Turku University Hospital

Turku, , Finland

Vaasa Central Hospital

Vaasa, , Finland

Sørlandet sykehus HF

Arendal, , Norway

Oslo University Hospital, Ullevål Hospital

Oslo, , Norway

Martina Hansens Hospital

Sandvika, , Norway

St. Olafs Hospital HF

Trondheim, , Norway

Skånevård Sund, Region Skåne

Helsingborg, , Sweden

Kalmar County Hospital

Kalmar, , Sweden

Linköping University Hospital

Linköping, , Sweden

Varberg Hospital

Varberg, , Sweden

Countries

Finland; Norway; Sweden

References

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.

Reference Type: DERIVED

PMID: 31110087 (View on PubMed)

Other Identifiers

ACCURATE

Identifier Type: -

Identifier Source: org_study_id