Rotator Cuff Tear
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Pan Am Clinic
Panam Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* massive (2+ tendons) or irreparable (see below) rotator cuff tears in the primary or revision setting. * Definition of irreparable: grade 3 or higher fatty infiltration into the infraspinatus
Exclusion criteria
* Protected populations: prisoners, military, non-English speakers, age \<18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analog scale for pain | 24-months | 10 cm scale with 0 = no pain and 10= extreme pain |
| Simple shoulder test | 24-months | A validated score of items whereby patients indicate ability to perform or not with a lower score equal to worse outcomes. Maximum 12 |
| American Shoulder and Elbow Score | 24-months | Validated shoulder and elbow outcome with a maximum score of 30, with 0 being poor outcome and 30 being the most positive outcome |
| Veterans Rand - 12 | 24-months | A validated general health survey with 0 as a poor outcome and 100 as a positive outcome. |
| Western Ontario Rotator Cuff score | 24-months | A validated measure with 0 as a poor score and 100 as a positive score. |
Countries
Canada
Contacts
Primary ContactSheila McRae, PhD
Outcome results
None listed