Acute Rotator Cuff Tear Related to TraumaNCT02885714

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

A study testing Rotator cuff repair and supervised specific exercises in people with Acute Rotator Cuff Tear Related to Trauma, run by Turku University Hospital at 17 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 45 to 70 years
Conditions the study is for: Acute Rotator Cuff Tear Related to Trauma
What is being tested?: Rotator cuff repair and supervised specific exercises
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 180 participants
Where: 17 sitesin 3 countries
Study dates: Dec 2016to Jan 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age of patient over 45 and below 70 years
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)
Shoulder symptoms relating to rotator cuff tear = pain laterally on the shoulder and/or painful motion arc during abduction or flexion
MRI documented full thickness supraspinatus (ssp) tear

Who cannot join

Traumatic event of the shoulder due a criminal act of violence with legal consequences
A delay of more than 4 months after the onset of symptoms of trauma to the day of intervention
Arthroscopically documented partial thickness rotator cuff tear only
A large MRI documented full thickness rotator cuff tear, sagittal tear size at the level of footprint larger than 3cm
MRI or arthroscopically documented total width of infraspinatus (isp) or subscapularis (ssc) tear
MRI or arthroscopically documented fully dislocated biceps tendon (biceps out of the groove) with concomitant subscapularis tear

Show all 24Show fewer

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))
Marked fatty degeneration in any of the cuff muscles (more than Fuchs/Goutallier grade 2)
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.
Concomitant clinically detectable motoric nerve injury affecting the shoulder
Radiographically documented severe osteoarthritis of the glenohumeral joint, Samilson-Prieto 2 or above
Non-congruency of the glenohumeral joint in radiographs (Hamada stage 2 or above)
Clinical stiffness of the glenohumeral joint (severely limited passive range of motion: glenohumeral external rotation < 30 degrees, and abduction with stabilized scapula <60 degrees)
Previous surgery of the affected shoulder (affecting clavicle, scapula or upper third of the humerus)
Earlier sonographic or MRI finding of a rotator cuff tear
Previous symptoms of the ipsilateral shoulder requiring conservative treatment (glucocorticosteroid injections and/or physiotherapy) delivered by health care professionals during the last five years
Systemic glucocorticosteroid or antimetabolite medication during the last 5 years
Ongoing treatment for malignancy
ASA classification 3 or 4
Patient's inability to understand written and spoken Finnish, Norwegian or Swedish
History of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardise informed consent
Patients with a contraindication/noncomplience for MRI examination or use of electrocautery devices
Previous randomization of the contralateral shoulder into the ACCURATE trial
Patient's denial for operative treatment and/or participation in the trial

Trial locations and contacts

17 sites in 3 countries.

Country

City, postcode or hospital

17 sites in 3 countries

Finland9 sites

Helsinki University Hospital
Helsinki
Central Finland Central Hospital
Jyväskylä
Kuopio University Hospital
Kuopio
Oulu University Hospital
Oulu
Satakunta Central Hospital
Pori
Hatanpää Hospital
Tampere
Tampere University Hospital
Tampere
Turku University Hospital
Turku
Vaasa Central Hospital
Vaasa

Other trials in Finland

Norway4 sites

Sørlandet sykehus HF
Arendal
Oslo University Hospital, Ullevål Hospital
Oslo
Martina Hansens Hospital
Sandvika
St. Olafs Hospital HF
Trondheim

Other trials in Norway

Sweden4 sites

Skånevård Sund, Region Skåne
Helsingborg
Kalmar County Hospital
Kalmar
Linköping University Hospital
Linköping
Varberg Hospital
Varberg

Other trials in Sweden

About this study

Official title: ACCURATE Trial - Operative Treatment of Acute Rotator Cuff Tear Related to Trauma; a Placebo-controlled Efficacy Trial

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
Being tested: Placebo surgery and supervised specific exercises, Rotator cuff repair and supervised specific exercises

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Placebo surgery and supervised specific exercisesProcedure or surgery
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.
Rotator cuff repair and supervised specific exercisesProcedure or surgery
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 groups in NCT02885714
Study group	Role	What they receive
Group I	Placebo comparator	Placebo surgery + supervised specific exercises Receives: Procedure: Placebo surgery and supervised specific exercises
Group II	Active comparator	Rotator cuff repair + supervised specific exercises Receives: Procedure: Rotator cuff repair and supervised specific exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (7)

Constant Score
Shoulder specific outcome measure combining subjective and objective variables
Measured: 3 and 6 months, 1 , 2, 5 and 10 years
Numeric rating scale of patients' shoulder pain during the last week at rest, during activity and at night.
Subjective pain intensity measure. The numeric pain rating scale (pain NRS). Scale 0 to 10. 0 = no pain and 10 = worst possible pain.
Measured: 3 and 6 months, 1 , 2, 5 and 10 years
15D
Generic health-related quality of life instrument
Measured: 3 and 6 months, 1 , 2, 5 and 10 years
Subjective patient satisfaction
Patient reported scale for treatment satisfaction
Measured: 3 and 6 months, 1 , 2, 5 and 10 years
Rotator cuff integrity in MRI investigation
Measured: 2, 5 and 10 years
Development of osteoarthritic signs in radiographs
Measured: 2, 5 and 10 years
Development of cuff tear arthropathy in radiographs
Measured: 2, 5 and 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2016Jan 2025

First posted31 Aug 2016 (estimated)
Study startDec 2016
Primary completionJan 2025
Study completionJan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acute Rotator Cuff Tear Related to TraumaStudies of the same condition, open and under way.
More trials run by Turku University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02885714
Sponsor's protocol ID: ACCURATE
Status last verified: Apr 2025
First submitted: 19 Aug 2016
Last updated: 1 May 2025
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

Publications

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.
PubMed 31110087

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ACCURATE Trial - Operative Treatment of Acute Rotator Cuff Tear Related to Trauma; a Placebo-controlled Efficacy Trial
ClinicalTrials.gov ID: NCT02885714
Acronym / sponsor ID: ACCURATE
Conditions: Acute Rotator Cuff Tear Related to Trauma
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Turku University HospitalOther government
Study start: Dec 2016
Primary completion: Jan 2025 (actual)
Study completion: Jan 2025 (actual)
First posted: 31 Aug 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group I	Placebo comparator	Procedure: Placebo surgery and supervised specific exercisesPlacebo surgery + supervised specific exercises
Group II	Active comparator	Procedure: Rotator cuff repair and supervised specific exercisesRotator cuff repair + supervised specific exercises

Who may qualify

Ages: 45 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age of patient over 45 and below 70 years
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)
Shoulder symptoms relating to rotator cuff tear = pain laterally on the shoulder and/or painful motion arc during abduction or flexion
MRI documented full thickness supraspinatus (ssp) tear

Key exclusion criteria (24 listed)

Traumatic event of the shoulder due a criminal act of violence with legal consequences
A delay of more than 4 months after the onset of symptoms of trauma to the day of intervention
Arthroscopically documented partial thickness rotator cuff tear only
A large MRI documented full thickness rotator cuff tear, sagittal tear size at the level of footprint larger than 3cm
MRI or arthroscopically documented total width of infraspinatus (isp) or subscapularis (ssc) tear

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebo surgery and supervised specific exercisesThe 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 or surgery	Group I
Rotator cuff repair and supervised specific exercisesThe 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.	Procedure or surgery	Group II

Primary outcome

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.

7 secondary outcomes

Constant Score
Time frame: 3 and 6 months, 1 , 2, 5 and 10 years
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
15D
Time frame: 3 and 6 months, 1 , 2, 5 and 10 years
Subjective patient satisfaction
Time frame: 3 and 6 months, 1 , 2, 5 and 10 years
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
Derived from this study: PubMed 31110087Ryosa 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.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Juha Kukkonen, MD, PhD principal investigator

Satakunta Central Hospital

Anssi Ryösä, MD study chair

Turku University Hospital

Hanna Björnsson Hallgren, MD, PhD study chair

University Hospital, Linkoeping

17 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Rotator cuff repair and supervised specific exercises in people with Acute Rotator Cuff Tear Related to Trauma, run by Turku University Hospital at 17 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Finland, Norway, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02885714, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.