Clinical trial NCT03878862: Surgical Management of Irreparable RC Tears
Official title: Surgical Treatment of Massive and Irreparable Rotator Cuff Tears
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rotator Cuff Tear
Lead sponsor: Panam Clinic
Sponsor class: OTHER
Collaborators: name: Pan Am Clinic
First posted: 2019-03-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting at the Pan Am Clinic to the contributing surgeons with an irreparable rotator cuff tear

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual analog scale for pain
timeFrame: 24-months
measure: Simple shoulder test
timeFrame: 24-months
measure: American Shoulder and Elbow Score
timeFrame: 24-months
measure: Veterans Rand - 12
timeFrame: 24-months
measure: Western Ontario Rotator Cuff score
timeFrame: 24-months
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Pan Am Clinic
state: Manitoba
Study officials:
References: