An observational study in Rotator Cuff Tear, sponsored by Panam Clinic. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-02.
Sponsored by Panam Clinic · Observational
The primary goal will be to compare the early postoperative recovery outcomes and complications from a series of surgical treatments for massive or irreparable rotator cuff tears. The secondary goal will be to assess factors that impact the outcomes of these reconstructions for irreparable posterosuperior rotator cuff tears.
Prospective, Non-Randomized Cohort Study The surgeons will decide which surgical reconstruction technique should be used to treat patients who have a massive (2+ tendons) or irreparable (Grade 3 or higher fatty infiltration into infraspinatus tendon) rotator cuff tear in the primary or revision setting. Surgical options include arthroscopic superior capsular reconstruction (SCR), arthroscopic assisted latissimus dorsi transfer (aaLDT), or arthroscopic assisted lower trapezius transfer (aaLTT), with arthroscopic biceps tendoesis/tenotomy as a control group.
Each patient will receive an X-ray and MRI to indicate reparable subscapularis tear, teres minor pathology, grade of muscle fatty infiltration, AHI, CSA, Hamada grade, and arthritis grade.
Patients will be assessed pre-operatively and again post-operatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months to collect patient reported outcomes and complications. Assessments will include clinical and shoulder motion evaluations to gauge shoulder range of motion and pathology, as well as questionnaires that evaluate the patients shoulder mobility, ability, pain, and surgical satisfaction. Any adverse events post surgery will also be recorded at the defined assessment time intervals (6 wks, 3m, 6m, 12m, 24,m) and will specifically monitor temporary or permanent nerve injuries, hematomas, superficial and deep infections, recurrent moderate/severe pain, tendon or graft rupture, and humeral head superior migration.
Graphical comparisons will be made of the patient's recovery for each surgical technique as well as an analysis of patient specific factors based on their demographics forms which could influence the recovery curves.
631 studies on the registry are indexed under Rotator Cuff Injuries; 156 are open to participants now.
This study's planned enrollment of 30 is below the median of 70 across 145 observational studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →Panam Clinic is the lead sponsor of 16 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients presenting at the Pan Am Clinic to the contributing surgeons with an irreparable rotator cuff tear
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
massive (2+ tendons) or irreparable (see below) rotator cuff tears in the primary or revision setting.
Exclusion criteria:
Visual analog scale for pain
10 cm scale with 0 = no pain and 10= extreme pain
Time frame: 24-months
Simple shoulder test
A validated score of items whereby patients indicate ability to perform or not with a lower score equal to worse outcomes. Maximum 12
Time frame: 24-months
American Shoulder and Elbow Score
Validated shoulder and elbow outcome with a maximum score of 30, with 0 being poor outcome and 30 being the most positive outcome
Time frame: 24-months
Veterans Rand - 12
A validated general health survey with 0 as a poor outcome and 100 as a positive outcome.
Time frame: 24-months
Western Ontario Rotator Cuff score
A validated measure with 0 as a poor score and 100 as a positive score.
Time frame: 24-months
Started Apr 2019 (actual). Primary completion is estimated for Apr 2026, 84 months after the start.
Of 57 non-industry observational studies under Rotator Cuff Injuries, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 67. This study's planned 84 months is above that.
Counting every sponsor, half of 72 studies reached it within 46 months; a quarter within 17 and three quarters within 165.
How these figures are worked out, and which studies are left out of them.
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