Back to resultsACCURATE Trial - Operative Treatment of Acute Rotator Cuff Tear Related to Trauma
Primary Purpose
Acute Rotator Cuff Tear Related to Trauma
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Placebo surgery and supervised specific exercises
Rotator cuff repair and supervised specific exercises
Sponsored by
About this trial
This is an interventional treatment trial for Acute Rotator Cuff Tear Related to Trauma
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Helsinki University Hospital
- Central Finland Central Hospital
- Kuopio University Hospital
- Oulu University Hospital
- Satakunta Central HospitalRecruiting
- Hatanpää Hospital
- Tampere University Hospital
- Turku University HospitalRecruiting
- Vaasa Central HospitalRecruiting
- Sørlandet sykehus HFRecruiting
- Oslo University Hospital, Ullevål HospitalRecruiting
- Martina Hansens HospitalRecruiting
- St. Olafs Hospital HFRecruiting
- Skånevård Sund, Region SkåneRecruiting
- Kalmar County HospitalRecruiting
- Linköping University HospitalRecruiting
- Varberg HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Group I
Group II
Arm Description
Placebo surgery + supervised specific exercises
Rotator cuff repair + supervised specific exercises
Outcomes
Primary Outcome Measures
Change in Western Ontario Rotator Cuff index (WORC) compared to baseline at two years.
Patient reported disease specific outcome measure for rotator cuff conditions.
Secondary Outcome Measures
Constant Score
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.
Subjective pain intensity measure. The numeric pain rating scale (pain NRS). Scale 0 to 10. 0 = no pain and 10 = worst possible pain.
15D
Generic health-related quality of life instrument
Subjective patient satisfaction
Patient reported scale for treatment satisfaction
Rotator cuff integrity in MRI investigation
Development of osteoarthritic signs in radiographs
Development of cuff tear arthropathy in radiographs
Full Information
NCT ID
NCT02885714
First Posted
August 19, 2016
Last Updated
October 25, 2021
Sponsor
Turku University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02885714
Brief Title
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
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 2016 (undefined)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2033 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turku University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Rotator Cuff Tear Related to Trauma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Placebo Comparator
Arm Description
Placebo surgery + supervised specific exercises
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
Rotator cuff repair + supervised specific exercises
Intervention Type
Procedure
Intervention Name(s)
Placebo surgery and supervised specific exercises
Intervention Description
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
Intervention Name(s)
Rotator cuff repair and supervised specific exercises
Intervention Description
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 Measure Information:
Title
Change in Western Ontario Rotator Cuff index (WORC) compared to baseline at two years.
Description
Patient reported disease specific outcome measure for rotator cuff conditions.
Time Frame
The change of WORC is also compared to baseline at 3 and 6 months, 1 , 2, 5 and 10 years
Secondary Outcome Measure Information:
Title
Constant Score
Description
Shoulder specific outcome measure combining subjective and objective variables
Time Frame
3 and 6 months, 1 , 2, 5 and 10 years
Title
Numeric rating scale of patients' shoulder pain during the last week at rest, during activity and at night.
Description
Subjective pain intensity measure. The numeric pain rating scale (pain NRS). Scale 0 to 10. 0 = no pain and 10 = worst possible pain.
Time Frame
3 and 6 months, 1 , 2, 5 and 10 years
Title
15D
Description
Generic health-related quality of life instrument
Time Frame
3 and 6 months, 1 , 2, 5 and 10 years
Title
Subjective patient satisfaction
Description
Patient reported scale for treatment satisfaction
Time Frame
3 and 6 months, 1 , 2, 5 and 10 years
Title
Rotator cuff integrity in MRI investigation
Time Frame
2, 5 and 10 years
Title
Development of osteoarthritic signs in radiographs
Time Frame
2, 5 and 10 years
Title
Development of cuff tear arthropathy in radiographs
Time Frame
2, 5 and 10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anssi Ryösä, MD
Phone
+35823138051
Email
anssi.ryosa@tyks.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Ville Äärimaa, Adj.Prof.
Phone
+35823130000
Email
ville.aarimaa@tyks.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juha Kukkonen, MD, PhD
Organizational Affiliation
Satakunta Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anssi Ryösä, MD
Organizational Affiliation
Turku University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hanna Björnsson Hallgren, MD, PhD
Organizational Affiliation
University Hospital, Linkoeping
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stefan Moosmayer, MD, PhD
Organizational Affiliation
Martina Hansens Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Teresa Holmgren, PT, PhD
Organizational Affiliation
University Hospital, Linkoeping
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mats Ranebo, MD
Organizational Affiliation
Kalmar County Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Berte Bøe, MD, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ville Äärimaa, Adj.Prof.
Organizational Affiliation
Turku University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Helsinki University Hospital
City
Helsinki
Country
Finland
Individual Site Status
Not yet recruiting
Facility Name
Central Finland Central Hospital
City
Jyväskylä
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juha Paloneva, Adj.Prof.
Facility Name
Kuopio University Hospital
City
Kuopio
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antti Joukainen, MD, PhD
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tapio Flinkkilä, Adj.Prof.
Facility Name
Satakunta Central Hospital
City
Pori
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juha Kukkonen, MD, PhD
Phone
+358 2 62771
Email
jupeku@utu.fi
Facility Name
Hatanpää Hospital
City
Tampere
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janne Lehtinen, Adj. Prof.
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antti Launonen, MD, PhD
Facility Name
Turku University Hospital
City
Turku
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anssi Ryösä, MD
Phone
+35823138051
Email
anssi.ryosa@tyks.fi
First Name & Middle Initial & Last Name & Degree
Ville Äärimaa, Adj.Prof.
Phone
+35823130000
Email
ville.aarimaa@tyks.fi
Facility Name
Vaasa Central Hospital
City
Vaasa
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pauli Sjöblom, MD
Facility Name
Sørlandet sykehus HF
City
Arendal
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sigurd Liavaag, MD, PhD
Facility Name
Oslo University Hospital, Ullevål Hospital
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Berte Bøe, MD, PhD
Email
berte2@mac.com
Facility Name
Martina Hansens Hospital
City
Sandvika
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Moosmayer, MD, PhD
Phone
+47 90723909
Email
st.moos@online.no
Facility Name
St. Olafs Hospital HF
City
Trondheim
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernd Wünsche, MD
Facility Name
Skånevård Sund, Region Skåne
City
Helsingborg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Knut Aagaard, MD
Facility Name
Kalmar County Hospital
City
Kalmar
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mats Ranebo, MD
Phone
+46 480 81432
Email
matsra@ltkalmar.se
Facility Name
Linköping University Hospital
City
Linköping
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanna Björnsson Hallgren, MD, PhD
Phone
+46 709-473276
Email
hanna.bjornsson.hallgren@regionostergotland.se
Facility Name
Varberg Hospital
City
Varberg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sven Gredevik, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31110087
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.
Results Reference
derived
Learn more about this trial
ACCURATE Trial - Operative Treatment of Acute Rotator Cuff Tear Related to Trauma
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