Outcomes of Massive Rotator Cuff Tendon Tear Treatment.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorTartu University Hospital
About this trial
Rotator cuff tear is the leading cause of shoulder pain in the elderly. There isn't enough evidence nor clinical guidelines to guide the treatment of massive rotator cuff tears, specially irreparable tears. Arthroscopic partial repair has been widely used and superior capsular reconstruction (SCR), either with allograft, autograft or augmentation with long head biceps brachii tendon (LHBBT), has been recently added. It is showing promising results, but lacking high quality evidence.
This is a prospective clinical study to compare the outcomes of different surgical methods for massive rotator cuff tendon tears. Minimal follow-up time will be two years. In this trial, massive rotator cuff tears will be anatomically repaired if possible. For irreparable tears a method will be randomly assigned intra-operatively once a tear is determined to be irreparable - either partial repair or partial repair with superior capsular reconstruction using the long head biceps brachii (LHBB) tendon. Patients who are eligible for the study but refuse operative treatment, will serve as conservative study group.
The hypothesis is that massive rotator cuff tears that are reparable will have the best functional outcomes. For irreparable tears, augmentation with LHBBT will give superior results over partial repair.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Massive rotator cuff tendon tear: grade III according to Davidson and Burkhart 2010 classification, diagnosed on MRI, and LHBB tendon is intact.
Primary rotator cuff pathology AND
Symptoms have not lasted more than 6 months.
In case of trauma, traumatic event no more than 6 months ago.
Disqualifiers
Previous rotator cuff surgery of the index shoulder.
Acute or chronic osteomyelitis.
Inflammatory joint disease (rheumatoid arthritis/ (pseudo)gout arthritis).
Uncontrolled diabetes.
Trial design
Design model
Parallel
Treatments tested in this trial
Arthroscopic rotator cuff partial repair with superior capsular augmentation with LHBBT
Procedure/SurgeryResidual rotator cuff defect will be reconstructed using LHBBT.
Arthroscopic rotator cuff partial repair
Procedure/SurgeryRotator cuff will be repaired with remaining residual defect.
Arthroscopic complete rotator cuff repair
Procedure/SurgeryArthroscopic complete repair as a standard procedure.
Suture anchor(s)
DeviceArthroscopic rotator cuff tendon(s) repair using suture anchor(s).
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: Arthroscopic rotator cuff partial repair with superior capsule augmentation with LHBBTExperimental treatment 2 interventions
Group B: Arthroscopic partial rotator cuff repairActive comparator 2 interventions
Group C: Arthroscopic rotator cuff repairOther 2 interventions
Group D: Rotator cuff tear conservative treatmentNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in shoulder strength
Measured by the change in rotator cuff strength isokinetic testing (abduction, internal and external rotation).
Time frame
Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit2
Change in shoulder range of motion.
Measured by the change in shoulder range of motion (abduction, internal and external rotation).
Time frame
Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit3
Functional outcome according to the American Shoulder and Elbow Surgeons (ASES) score.
Measured by the change in joint functional score. The higher the score, the better the outcome. The patient self-assessment (pASES) includes 6 pain items and 10 functional items that are shoulder specific (Angst, 2008). The pASES form has 3 sections: pain, instability, activities of daily living (ADLs) (Goldhahn, 2008). Pain section: 4 questions with yes/no responses, 1 question covering number of pain tablets per day, and a VAS (visual analogue scale) from 0 (no pain) to 10 (worst pain). Instability section: 2 questions (1. Response yes/no about feelings of instability, 2. Quantify instability from 0 (stable) to 10 (very unstable)). Activities of daily living (ADLs): Each shoulder is included (affected/non affected), 10 items, with a 4 point ordinal scale, range: 0 (unable to perform activity) to 3 (no difficulty in doing activity) (Goldhahn 2008).
Time frame
Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit4
Functional outcome according to the Constant-Murley score (CMS).
Measured by the change in joint functional score. The higher the score, the higher the quality of the function. The test is divided into four subscales: pain (15 points), activities of daily living (ADL) (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points).
Time frame
Pre-operative baseline, 6-months, 12-months and 24-months follow-up visitSecondary outcomes
1
Integrity of surgically repaired rotator cuff tendons on MRI studies using Sugaya classification (2005).
Integrity of surgically repaired rotator cuff tendons on post-operative MRI studies. Classified into five categories (from intact tendon to full tear): Type I: sufficient thickness with homogeneously low intensity; Type II: sufficient thickness with partial high intensity; Type III: insufficient thickness without discontinuity; Type IV: the presence of a minor discontinuity; Type V: the presence of a major discontinuity.
Time frame
postoperatively 6 months, 12 months and 24 months2
Change in quality of life
Measured by the change in score according to EEK-2 (emotsionaalse enesetunde küsimustik, Emotional State Questionnaire) score. The higher the score, the higher the risk of having emotional state disabilities. The overall score ranges from 0-112, but it is divided into six categories that are assessed separately.
Time frame
Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit3
Change in kinesiophobia score
Change in kinesiophobia score according to Tampa Scale for Kinesiophobia. The higher the score, the higher the degree of kinesiophobia. Results consist of a total raw score (range between 17 and 68) and two subscale scores (activity avoidance and somatic focus).
Time frame
Pre-operative baseline, 6-months, 12-months and 24-months follow-up visitLocations
Sponsors and contacts
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Tartu University Hospital
Lead sponsor
University of Tartu
Collaborator
Source ClinicalTrials.gov
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